Sativex, a cannabis-derived drug for treating muscle spasms in multiple sclerosis, could be available in Wales but blocked in England.
GW Pharmaceuticals, the British company that develops cannabis-based medicines, is facing the prospect of having its multiple sclerosis treatment blocked in England but available in Wales.
The Welsh medicines board has recommended the use of Sativex to treat medium to severe muscle spasms in multiple sclerosis and is awaiting final approval from the devolved Government, The Sunday Telegraph has learnt.
Sativex could, however, be blocked from routine use in England. Draft guidelines from the National Institute of Health and Care Excellence (Nice), issued in April, recommended against the use of Sativex in multiple sclerosis. If this remains unchanged in the final guidelines, expected in October, Sativex will not be available on the NHS in England.
Justin Gover, chief executive of GW Pharmaceuticals, said it was a “travesty” that different parts of the UK could have different guidelines on Sativex, a mouth spray made from compounds derived from the cannabis plant.
“We very much hope that it [Nice] will indeed endorse use of the medicine – it would make little sense if you could drive to Wales and get the drug but not in England,” he added.
The draft guidelines have also attracted criticism from neurologists and patient groups, who say Sativex and Famprya, another drug which could be blocked, can stop patients “screaming out” in pain.
Experts have questioned Nice’s cost-benefit methodology, saying it had vastly overestimated the doses needed for the effective management of symptoms.
Sativex has been licensed for use in the UK since 2010, but did not undergo a clinical assessment until this year, with Nice due to update its multiple sclerosis guidelines for the first time in a decade.
About 100,000 people in the UK currently have MS.
Source: The Daily Telegraph © Copyright of Telegraph Media Group Limited 2014 (11/08/14)
People with multiple sclerosis are on the verge of being denied two drugs that help alleviate pain as a result of new NHS recommendations.
Fampyra and Sativex have been licenced in recent years to help people who experience mobility problems and muscle spasms.
However, the National Institute of Health and Care Excellence (NICE) is due to reject the drugs as treatments for MS, with experts saying they are not cost-effective.
In a letter to the Daily Telegraph, a group of experts including the head of the MS Society and seven neurologists say NICE has not taken full account of the "life-changing" differences the two drugs make to sufferers' lives.
"NICE is proposing to block access to two potentially life-changing MS treatments which are licensed and proven to be effective at helping people walk more easily and control painful muscle spasms," they wrote.
"If this guideline remains unchanged, people will be forced to pay privately, or face the agonising daily frustration of living with painful and debilitating symptoms, knowing there are drugs that may help them, but that they can't get access to."
Fampyra helps treat mobility problems, while sativex can be used to treat muscle spasms. On a private prescription, they would cost an MS surferer between £200 and £350.
The experts said NICE has over-estimated how much medication people would need for the drugs to be effective.
It is estimated that of the 100,000 people in the UK with MS, 40,000 would benefit from Fampyra and Sativex.
Michelle Mitchell, chief executive of the MS Society, told the Telegraph: "We understand that NICE has to make difficult decisions which balance cost to the NHS with the efficacy of a given treatment. But we don't understand why NICE deliberately excluded organisations that represent people with MS from a process which resulted in a proposal that two relatively affordable drugs with proven efficacy should be not be used in the NHS."
Willy Notcutt, Consultant in Pain Management at James Paget University Hospital, Norfolk, added: "Many people, including doctors, don't really understand how unpleasant symptoms such as spasms are - for example someone screaming in pain whenever someone tries to wash them.
"For many of them these treatments are invaluable and make life worth living again."
NICE said organisations will have their chance to comment and that the guidelines will be revised if new evidence emerges in support of Fampyra and Sativex.
Source: International Business Times © Copyright 2014 IBTimes Co., Ltd (10/06/14)
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)
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 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; email@example.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)
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)
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)
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)