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Sativex regulatory approval in Switzerland(27/11/13)

GW Pharmaceuticals plc, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced that it has received regulatory approval for its prescription medicine Sativex(R) in Switzerland. A full marketing authorization has been granted by the Swissmedic authorities in the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. Launch timing is dependent on completion of pricing and reimbursement procedures. Sativex will be commercialized in Switzerland by GW's European partner, Almirall S.A.

"This approval in Switzerland marks yet another regulatory success for Sativex, which is now approved in a total of 23 countries," stated Justin Gover, Chief Executive Officer of GW. "We now look forward to working with our partners, Almirall, towards this launch so as to enable MS patients in Switzerland to benefit from this important new treatment."

Sativex is approved for use in the treatment of MS spasticity in 23 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait.

Source: GW Pharmaceuticals plc (27/11/13)

Mutual recognition procedure for Sativex® in France announced(21/10/13)

GW Pharmaceuticals plc, today announced the successful closing of the European Mutual Recognition Procedure (MRP) in France for Sativex(R) oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS) and a resulting recommendation for approval by the French authorities.

The next step in the regulatory process is to work with the French National Agency of Medicine and Health Products Safety (ANSM) to finalize any country-specific requirements. Following completion of this next step, it is then expected that France will issue a national marketing authorisation. Launch timing in France is dependent on completion of subsequent national pricing and reimbursement procedures. Sativex will be commercialized in France by GW's European partner, Almirall S.A.

"The successful completion of this regulatory process for Sativex in France maintains our positive regulatory track record for Sativex, which is already approved in 22 countries, and provides further endorsement of the important role Sativex can play in meeting a substantial unmet need of people with Multiple Sclerosis," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "We look forward to working with our partners, Almirall, towards the launch of Sativex in this important European country." Sativex is approved as a treatment for MS spasticity in 22 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden, Italy and Finland with launches currently in preparation for a further 8 European countries, as well as Australia, New Zealand and Kuwait.

In the United States, GW announced in August 2013 that it had opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex(R) for the treatment of MS spasticity. GW expects the U.S. Phase 3 trial to commence in 2014.

Sativex is also currently in Phase 3 clinical trials as a treatment for cancer pain. This represents the lead target indication for the product in the United States.

Source: GW Pharmaceuticals plc (21/10/13)

GW Pharma says new studies reinforce efficacy, safety of Sativex(02/10/13)

GW Pharmaceuticals PLC said new test data had reinforced the efficacy and safety profile of its Sativex drug for treatment of Multiple Sclerosis spasticity.

It said the latest results from several studies show that the drug's effectiveness is maintained long term with no additional safety concerns identified in clinical practice.

It will present the data Wednesday at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Copenhagen.

Sudies in specialist MS centres across the EU showed improvements in spasticity were confirmed by more than 70% of patients, but also by physicians and carers, with Sativex was generally well tolerated, GW Pharma said in a statement.

Another study conducted in three German centres showed the drug had no adverse effects on driving ability, the MS spasticity and spasms count improved and the treatment was again well tolerated.

Sativex is a cannaboid which is administered in spray form. It has been launched in 11 countries including the UK, Spain, Italy and Germany, and has approvals for a further 11 countries.

GW Pharma shares were up 2.4% at 86.78 pence Wednesday morning.

By Steve McGrath; stevemcgrath@alliancenews.com; @SteveMcGrath1

Source: Copyright 2013 Alliance News Limited. All Rights Reserved. (02/10/13)

US Investigational new drug application (IND) for Sativex® phase 3 clinical program for MS spasticity(14/08/13)

GW Pharmaceuticals plc announced today that it has opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of spasticity due to Multiple Sclerosis (MS). Sativex is currently approved in 22 countries outside the U.S. as a treatment for MS spasticity.

The proposed U.S. Phase 3 program will be conducted under the agreement with GW’s licensing partner for Sativex®, Otsuka Pharmaceutical Co. Ltd. Under the terms of GW’s agreement with Otsuka, Otsuka is responsible for wholly funding the MS Phase 3 clinical program, as is the case with the current Phase 3 cancer pain program.

As part of its MS spasticity IND application, GW requested feedback from the FDA on key features of the proposed single Phase 3 trial protocol. GW expects to work with the FDA over the coming months to incorporate FDA feedback and to finalize the protocol design, which may include a request for Special Protocol Assessment (SPA). GW expects the Phase 3 trial to commence in 2014.

Cancer pain remains the initial target indication for Sativex in the U.S. and it is intended that MS spasticity would represent a future second indication for the U.S. market. GW and Otsuka are currently undertaking a Phase 3 clinical trial program for Sativex in cancer pain and results from two pivotal Phase 3 trials are expected in 2014.

“With results from our U.S. Phase 3 program in cancer pain due next year, this new Phase 3 IND provides us with the opportunity to broaden the future U.S. market potential for Sativex to include MS spasticity. As such, this new IND represents an important extension of GW’s and Otsuka’s ambitions for Sativex in the U.S.,” stated Justin Gover, Chief Executive Officer of GW. “We now look forward to working with the FDA to gain agreement on the required program to enable a future filing of an NDA for the MS indication.”

Source: GW Pharmaceuticals plc (14/08/13)

Sativex has no long-term negative effect on MS cognition(05/08/13)

GW Pharmaceuticals plc announced top-line results from a 12 month placebo-controlled study of Sativex in patients with spasticity due to Multiple Sclerosis (MS). The study results confirm the reassuring safety profile of Sativex and provide further evidence of long-term efficacy.

The study was a 12 month multicentre, double-blind, randomised parallel group, placebo-controlled study in 121 patients with MS spasticity. The study was required as a post-approval commitment by the UK regulatory authority, the Medicines and Healthcare products Regulatory agency (MHRA), with the primary objective of evaluating whether Sativex may have long term adverse effects on cognitive function or mood. The primary endpoint was the change in cognitive function as assessed by the total Paced Auditory Serial Addition Test (PASAT) score from baseline to end of treatment. Mood was assessed by the Beck Depression Inventory-II.

There was a slight improvement in the PASAT score from the beginning to the end of the study in both the Sativex and placebo groups, thus confirming that there is no evidence of long-term cognitive impairment in patients taking Sativex compared with those taking placebo. Similarly, the change in mood over the 12 month period was more or less identical in the Sativex and the placebo group, confirming no untoward effect on mood.

The key efficacy secondary endpoints were the global impression of change scores as assessed by the patient, physician and carer. Each of these endpoints was highly significantly in favour of Sativex (p<0.0001, p=0.001 and p=0.004 respectively).

Detailed data from this study is due to be presented at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on 2-5 October in Copenhagen, Denmark.

Dr Stephen Wright, GW's R&D Director, said, "We are pleased to report positive and wholly reassuring results from this 12 month placebo-controlled study in patients with MS spasticity. We have now shown that Sativex does not impair cognition either in short-term or in long-term use in well designed, randomised, placebo controlled clinical trials. These data not only confirm the good tolerability of Sativex in long-term use but also provide further evidence of efficacy consistent with that seen in previous shorter duration clinical trials."

Source: Market Watch Copyright © 2013 MarketWatch, Inc (05/08/13)

New regulatory application for MS cannabis spray Sativex® approval in France(22/07/13)

GW Pharmaceuticals plc announced that it has submitted an application under the European Mutual Recognition Procedure (MRP) seeking to expand the marketing authorisation for Sativex® into France for the treatment of spasticity due to Multiple Sclerosis (MS).

This new regulatory application follows a Decree signed by the French Minister of Health in June 2013, which amended national legislation in France so as to permit a prescription cannabis-based medicine, subject to approval by ANSM, the French regulatory authority. As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.

Sativex is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is currently available on prescription in the UK, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy with launches currently in preparation for a further 8 European countries, as well as Australia and New Zealand.

"Sativex meets a significant unmet medical need for patients with Multiple Sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," stated Justin Gover, Chief Executive Officer of GW Pharmaceuticals. "The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe. We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with Multiple Sclerosis."

Almirall, an international pharmaceutical company with headquarters in Spain, is the exclusive distribution partner for Sativex in the European Union (excluding the United Kingdom) and E.U. accession countries, as well as Switzerland, Norway, Turkey and Mexico.

Source: GW Pharmaceuticals plc (22/07/13)

Cannabis spray Sativex® launched in Italy for MS spasticity(08/07/13)

GW Pharmaceuticals & Almirall S.A. anounced today that Sativex® is now available in Italy as a prescription medicine for use in the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. The launch follows receipt of full marketing authorization for Sativex® by the Italian health authorities in May. The medicine is reimbursed by the Italian authorities as a Class H (hospital dispensed) medicine. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex® price in Spain.

"As one of the largest markets in Europe, the launch of Sativex® in Italy is a key milestone in the commercialization of this important new medicine. Italy represents yet another addition to the growing number of countries in Europe in which Sativex® is now available to treat MS spasticity, a particularly debilitating symptom of MS that is not adequately treated with currently available medications," stated Justin Gover, Chief Executive Officer of GW. "With a total of 21 countries that have now approved Sativex® for use in the treatment of MS spasticity, and a further 9 countries in which regulatory submissions are ongoing, we look forward to a series of further commercial launches over the coming twelve months."

Source: GW Pharmaceuticals (08/07/13)

Sativex® commercialisation approval in Italy(07/05/13)

GW Pharmaceuticals plc has announced that it has received commercialisation approval for its prescription medicine Sativex® in Italy. A full marketing authorization has been granted by the authorities in Italy for the treatment of moderate to severe spasticity in Multiple Sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. This license to market Sativex® in Italy comes by way of the publication of Sativex® in the Italian Official Journal (Gazzetta Ufficiale) and reflects that regulatory, pricing and reimbursement approvals are now in place for an expected commercial launch in September by GW's partner, Almirall S.A. The reimbursed price of the medicine granted by the authorities in Italy is consistent with the reimbursed Sativex® price in Spain.

The publication of Sativex® in the Italian Official Journal triggers a €250,000 milestone payment from Almirall to GW.

"The approval in Italy brings the total to 21 countries that have approved Sativex® for use in the treatment of MS spasticity," stated Justin Gover, Chief Executive Officer of GW. "In granting reimbursement approval for Sativex®, we appreciate the foresight of the Italian authorities in recognizing the value of a medicine that treats a particularly debilitating symptom of MS that is not adequately treated with currently available medications. We now look forward to working with our partners Almirall towards commercial launch in this important market in a few months' time."

Source: GW Pharmaceuticals plc (07/05/13)

US patent allowance for MS drug Sativex® formulation spray device(22/04/13)

GW Pharmaceuticals plc has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/606,742, a patent application directed to the spray device of its Sativex® product formulation. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.

The patent claims a metered valve pump spray device consisting of a liquid cannabis extract, in propylene glycol and ethanol, which is adapted to spray a dose towards a patient's sublingual mucosa. The issued patent from this application is expected to expire in March 2021.

"This Notice of Allowance directed to the Sativex delivery device comes soon after the 13/607,897 Notice of Allowance directed to a method of sublingual delivery of the Sativex pharmaceutical formulation. Not only does GW have claims directed to the method of sublingual delivery of the Sativex formulation, but it also has claims directed to the device within which it is contained," stated Justin Gover, GW's Chief Executive Officer. "In total, we now have seven different patent families containing one or more pending or issued patents relating to Sativex."

GW's intellectual property portfolio includes multiple patent families with issued or pending claims directed to plants, plant extracts, extraction technology, pharmaceutical formulations, drug delivery and the therapeutic uses of cannabinoids, as well as plant variety rights, know-how and trade secrets.

GW's granted patents and pending applications (if they were to issue) in the US relating to Sativex would expire on various dates between 2021 and 2026, excluding possible patent term extensions.

In the US, Sativex is currently in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and elsewhere.

Source: GW Pharmaceuticals plc (22/04/13)

Cannabis-based oral spray approved for use in Ireland(12/04/13)

The Irish medical board has approved a cannabis-based spray, which can ease symptoms and significantly improve the quality of life of people suffering from illnesses like multiple sclerosis.

However the Medical Independent reports that the spray cannot be made available in the country until the government changes the current legislation around the Misuse of Drugs Act.

The legislation prohibits the production and possession of cannabis-based medicines in the same way as cannabis itself. The Department of Health has indicated that it will put forward proposals to change the law by the middle of 2013 but has said that it will be complex as it is wary of watering down drugs legislation.

It is estimated that between 10 and 30 per cent of MS patients in Europe smoke cannabis to ease the pain and other disabling symptoms of the disease and the Medical Independent reports that many sufferers in Ireland, waiting for the Sativex spray to become available, feel they have no option but to source it illegally.

Though it is not understood exactly how the chemicals in the medicine work, MS Ireland has said that many of the 8,000 people in Ireland who suffer from the disease could benefit from it.

Source: thejournal.ie © Journal Media Ltd. 2013 (12/04/13)

MS medicaton Sativex® moved to Schedule 4 of UK Drugs Act(11/04/13)

Legal step lessens restrictions, recognises low potential for abuse and low risk of diversion.

GW Pharmaceuticals, the biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform, announced that Sativex®, its treatment for spasticity in Multiple Sclerosis, has today been rescheduled in the UK from Schedule 1 under the Misuse of Drugs Act to Schedule 4, Part 1. The move follows a recommendation to the Home Office by the Advisory Council on Misuse of Drugs (ACMD), which determined that Sativex® has a low potential for abuse and low risk of diversion.

This new, less restrictive scheduling means that Sativex® can be prescribed in the UK with no restriction on supply, recording, storage or destruction. The change confirms the distinction between Sativex® - with its evidence of quality, safety and efficacy as recognised by the Medicines and Healthcare products Regulatory Agency (MHRA) - and crude herbal cannabis, which will remain on Schedule 1 of the Act.

"This rescheduling is an important legal milestone for Sativex®, both in the UK and around the world. It provides a strong reference source for lawmakers and will help differentiate Sativex® and any future cannabinoid prescription medicines developed by GW from crude herbal cannabis," stated Dr. Geoffrey Guy, GW's Chairman. "Achieving a low restrictive scheduling for Sativex® was one of the fundamental goals that GW set out to achieve from inception and we are delighted that the extensive scientific data generated over the last decade has informed the UK government in making this important decision."

Source: GW Pharmaceuticals (11/04/13)

Sativex may be pulled in German price row(20/03/13)

GW Pharmaceuticals and Almirall may stop selling the cannabis drug Sativex in Germany after health authorities refused to agree a price that the companies view as acceptable.

GW - which developed the under-the-tongue spray as a treatment for spasticity in multiple sclerosis - said on Tuesday the German authorities had determined a price that was significantly lower than in other European countries.

"Our partners, Almirall, consider the German price to be unacceptable and plan to take all necessary steps to challenge the decision, which may include suspension or withdrawal of supply in Germany, whilst they pursue a reasonable solution," GW said in a statement.

GW said it expected to make a provision of 800,000 pounds($1.21 million) to reflect the impact of the pricing decision by the German National Association of Statutory Health Insurance Funds.

A spokesman declined to disclose the price that had been offered in Germany. In Spain, Sativex sells for 4.40 euros($5.70) per day and the cost is similar in Britain, he added.

The drug, which contains active cannabis ingredients, is also on sale in Denmark, Norway, Sweden, Canada and Israel.

Sativex has not yet been approved in the United States, where it is currently being tested in final-stage Phase III clinical trials for advanced cancer pain.

In anticipation of tapping into the U.S. market, GW also announced on Tuesday that it planned to list its shares on the Nasdaq market, in addition to London.

Source: Reuters © Thomson Reuters 2013 (20/03/13)

No strong evidence to back use of cannabis extract in Multiple Sclerosis(13/12/12)

There is no strong evidence to back the use of cannabis extract in the treatment of Multiple Sclerosis (MS), concludes a review of the available evidence on the first licensed preparation, published in the December issue of Drug and Therapeutics Bulletin (DTB).

Sativex, in the form of a mouth spray, contains the principal extracts—dronabinol and cannabidiol—found in the leaf and flower of the cannabis plant. It is the first cannabinoid preparation to be licensed for use in the treatment of muscle spasms in MS.

MS is estimated to affect around 100,000 people in the UK, and around one in every 1000 people will develop the condition in the UK.

An increase in muscle tone, or spasticity is a common symptom of the condition, causing involuntary spasms, immobility, disturbed sleep, and pain.

Complex combinations of drugs are sometimes needed to manage spasticity, but they don't work that well and have a range of unpleasant side effects.

Sativex is intended for use as a second line treatment in patients in whom these other options have failed. But the DTB review found that the trial data on which the success of Sativex is based, are limited.

Overall, the trials, on which the drug's approval was based, did show a small difference in the numbers of patients who in whom symptoms abated compared with those taking a dummy (placebo) preparation.

But in many of these studies, Sativex was used for relatively short periods—from six weeks to four months. And none included an active ingredient with which the effects of Sativex could be compared.

Two of the trials included doses that exceeded the 12 daily sprays for which the preparation is licensed. One trial did not have sufficient numbers of participants to validate the results.

A third trial, which was properly designed, and did have sufficient numbers of participants, did not find any significant difference in symptom relief between those who took Sativex and those who didn't.

The preparation is also expensive, notes DTB, and costs around 10 times as much as other drugs used for the secondary treatment of MS muscle spasms.

As yet, the body that advised the NHS on its use of treatments, the National Institute for Health and Clinical Excellence (NICE) has not offered any advice on the use of cannabis extract either, although it is set to do so.

But the DTB review says that the strength of the evidence is insufficient to warrant its routine use. "We believe that such limitations make it difficult to identify the place of this product in clinical practice," it concludes. Commenting on the review, GP and DTB editor, James Cave, said the findings of the review were "disappointing."

"MS is a serious and disabling condition, and it would be great to say that this drug could make a big difference, but the benefit is only modest," he said.

Source: BMJ-British Medical Journal & Science Codex (13/12/12)

Positive new Sativex® data from Germany presented at ECTRIMS(12/10/12)

Almirall S.A. announced that results of the MObility ImproVEments with Spasticity in Multiple Sclerosis (MOVE) 2 observational study performed in Germany, with 300 patients, showed that one month's treatment with Sativex®(THC:CBD) oromucosal spray reduces moderate to severe multiple sclerosis spasticity (MSS) by 20% or more in 4 out of 10 patients previously unresponsive to conventional therapies. After three months, the improvement observed was 30% or more. Overall, 55% of the initial patients were eligible for continuing treatment beyond the third month.

This prospective, observational study is presented today at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France.

"An improvement on the numerical rating scale (NRS) of at least 30% after 3 months is considered clinically relevant. For patients, it translates into less disturbed sleep due to MSS spasms, less pain, improved bladder function and a greater ability to perform simple daily activities involving mobility. These findings from everyday clinical practice are aligned or superior to those reported in previous clinical trials with Sativex®, and were achieved with slightly fewer average daily doses," commented MOVE 2 lead investigator Professor Peter Flachenecker, Neurological Rehabilitation Centre Quellenhof, Bad Wildbad, Germany.

The MOVE 2 is a multicentre, prospective, observational study including 300 adults with moderate to severe MSS treated in 42 specialised MS centres throughout Germany. Mean MS spasticity NRS scores decreased by 25% compared to pre-treatment with Sativex®, with 41% of patients improving at least 30% from baseline (from 6.7 to 3.2 in this subgroup; p<0.0001). Quality of life measurements (MS QoL-54 scale) also improved from baseline in the third month's visit (p<0.01).

Sativex® was generally well tolerated. Adverse events were reported in 16.6% of the treated patients, being the most common ones dizziness, fatigue or drowsiness mostly transient and mild or moderate in intensity.

Other new data from Sativex®' ongoing registries in the UK (n=493, retrospective data collection, 18 months mean exposure) and Spain (n=103, 6 months prospective follow-up) which are being presented in this congress, further support these findings.

On top of the clinical relevance demonstrated in the MOVE 2, a recent publication from J. Slof shows that Sativex® is a cost effective treatment. In a Markov model from the German healthcare payer perspective, the incremental cost effectiveness ratio for Sativex® was €10,809. This is well below commonly accepted thresholds for cost effectiveness, such as the £30,000 (€38,000) specified by the UK National Institute for Health and Clinical Excellence (NICE).

In Europe, Sativex® is commercialised for the treatment of MS spasticity in the UK, Spain, Germany and Denmark. Launches are also currently in preparation in Italy, Austria, Iceland and Norway. In addition, regulatory authorization has been also received in Belgium, Sweden, the Netherlands, Portugal, Czech Republic and Slovakia with launches expected from the end of 2012 onwards.

In addition to MS spasticity, Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.

Source: GW Pharmaceuticals plc (12/10/12)

Cannabis sativa for spasticity due to MS: added benefit not proven(25/09/12)

An extract from the plant Cannabis sativa (trade name Sativex®) was approved in May 2011 for patients suffering from moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS). In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the new drug, which is used as a mouth spray, offers an added benefit over the optimized standard therapy.

However, no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.

Comparison of different possibilities for optimizing treatment

The extract from Cannabis sativa, which contains the active ingredient combination of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), is approved as add-on therapy to the already used antispastic drugs. Usually, drugs such as baclofen or tizanidine are given to treat muscle spasms. The cannabis extract can be considered when, despite an individual, patient-tailored use of these drugs, the symptoms caused by spasticity cannot be adequately relieved.

The G-BA specified an optimized standard therapy containing baclofen, tizanidine or drugs that are approved for the treatment of spasticity in underlying neurological diseases as the appropriate comparator therapy. At least two previous attempts at treatment were to have been made, in each of which different oral antispastic (spasmolytic) drugs had been used in an optimum way. Again, at least one product was to have contained the active ingredients baclofen or tizanidine. The aim of the assessment by IQWiG was to compare the additional administration of the Cannabis sativa extract with other available possibilities for optimizing treatment and to assess the added benefit.

Optimization of premedication was not planned in any of the studies

However the manufacturer deviated from this specification of the G-BA, without providing adequate justification for doing so. In its dossier, the manufacturer drew no conclusions about the extent and probability of the added benefit compared to the appropriate comparator therapy specified by the G-BA. The studies submitted by the manufacturer were not suitable for reaching conclusions on added benefit in comparison with an optimized standard therapy. This was because in none of these studies was it planned to optimize the antispastic premedication. Instead, this treatment was to be continued unchanged. Therefore there is no proof from the manufacturer's dossier of an added benefit of Cannabis sativa extract compared to the appropriate comparator therapy of the G-BA.

Source: Medical News Today MediLexicon International Ltd © 2004-2012 (20/09/12)

Post Script 27/11/12

In June this year, a resolution of the German Federal Joint Committee (G-BA) on the early evaluation of benefits for Sativex was positive. The G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. The G-BA determined that there was an indication of minor added benefit of Sativex® as an add-on therapy in MS-induced spasticity. This was in contrast to the previous evaluation by the IQWiG that had certified no additional benefit for technical reasons. The G-BA has now confirmed this position and certified an additional benefit to Sativex’s use in MS Spasticity management.(25/09/12)

Sativex long-term use: an open-label trial in patients with spasticity due to MS(14/08/12)

Summary: This new study from a research group in Scotland assesses the long term safety profile of regular Sativex use for spasticity in MS.

The report, which follows-up 146 patients using treatment for a mean duration of 334 days, administering a mean of 7.3 actuations per day, found that 36% withdrew in the first year, either due to adverse events of lack of efficacy. Most common adverse events were fatigue and dizziness. Serious adverse events were rare and included two psychiatric events in the same patient. No serious effects were seen with abrupt withdrawal and patients did not build up a tolerance to the drug in this study.

Abstract Sativex is an endocannabinoid system modulator principally containing Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD). During a 6-week randomised controlled trial, Sativex had a clinically relevant effect on spasticity associated with multiple sclerosis (MS).

Patients self-titrated oromucosal Sativex to symptom relief or maximum tolerated dose (maximum of 130 mg THC and 120 mg CBD daily).

The primary objective was to evaluate the safety and tolerability of long-term treatment by recording the incidence and severity of adverse events (AEs).

Secondary outcomes were to determine evidence of developing tolerance and to assess the long-term dosing profile of Sativex.

A validated 11-point Numerical Rating Scale of spasticity severity was used to assess efficacy. A total of 146 patients elected to enter this open-label follow-up safety trial.

Mean treatment exposure was 334 days (standard deviation, SD = 209 days), and patients administered on average 7.3 (SD = 4.42) actuations per day.

Fifty-two (36 %) patients withdrew from the study in the first year, 14 % due to AEs and 9 % due to lack of efficacy. Most AEs were mild/moderate in severity. Common (>10 %) treatment-related AEs were dizziness (24.7 %) and fatigue (12.3 %).

Serious AEs occurred in five patients (3.4 %), with two psychiatric events reported by one patient.

No psychoses, psychiatric AE trends, or withdrawal symptoms occurred following abrupt cessation of treatment.

Baseline symptoms including spasticity did not deteriorate but were maintained to study completion in those patients who did not withdraw. No new safety concerns were identified with chronic Sativex treatment, and serious AEs were uncommon.

There was no evidence of tolerance developing, and patients who remained in the study reported continued benefit.

Serpell MG, Notcutt W, Collin C.

Pain Clinic, Division of Developmental Medicine, Department of Anaesthetics, Gartnavel General Hospital, University of Glasgow, Glasgow, UK

Source: J Neurol. 2012 Aug 10 & Pubmed PMID: 22878432 (14/08/12)