Cannabis and cannabinoids
Drug development company MMJ PhytoTech has said it plans to initiate clinical studies of new capsule formulations derived from cannabis for the treatment of MS later this year.
Their phase 1, safety-oriented clinical studies have been approved by various ethics committees and public health organisations in America. The company has been actively investigating a new capsule that reportedly offers advantages over smokeable cannabinoid formulations, as oral administration is much more controllable and user-friendly.
Furthermore, the company says it is confident that their capsules can withstand room temperature storage for extended periods of time. In this way, the need for refrigeration is eliminated resulting in lower shipping and storage costs.
The company believes these advantages will give rise to a low cost cannabinoid alternative with potentially high patient compliance. The safety of these Tetrahydrocannabinol and Cannabidiol capsules will be tested in a small group of volunteers to test for adverse effects. They are expected to have a low frequency of side effects and, if proven as such, the company plans to conduct Phase 2 clinical studies to investigate the efficacy and optimal dosing schedule for MS patients. After the studies are complete, the company will hope to develop Phase 3 clinical trials to assess efficacy, effectiveness and safety of the drug in around 1,000 MS patients.
Source: Multiple Sclerosis News Today © BioNews Services 2015 (27/08/15)
Human trials for marijuana chewing gum(27/08/15)
Cannabis-focused biotech company AXIM Biotechnologies has launched clinical trials on humans for medical cannabis chewing gum as a treatment for multiple sclerosis.
The gum, MedChew RX, contains five milligrams of cannabidiol — a non-psychoactive component of cannabis — and five milligrams of THC — a psychoactive cannabinoid.
Medical marijuana chewing gum “should allow for predictable and controlled release of the active ingredients,” George Anastassov, chief executive of AXIM, said in a statement.
It should not be socially stigmatising, should have a pleasant taste and consistency and no undesirable side effects, he added. “Chewing gum meets all these criteria.”
AXIM already has a cannabinoid chewing gum product, known as CanChew, on the market, however it does not contain THC and does not offer any medical claims.
The psychoactive component of THC is an effective way to treat patients with degenerative conditions, in addition to the medicinal properties of cannabidiol, which can be used to treat neurological conditions such as epilepsy and multiple sclerosis.
Additionally, the act of chewing helps preserve cognition and memory, as well as promotes overall oral health, Anastassov told MarketWatch.com.
While the current trials of the gum are only for MS patients, Anastassov says Axim hopes to expand the range of conditions it can be prescribed for.
“For multiple sclerosis, the market for treatment is quite large,” Anastassov says. “Eventually, we will try to enlarge the conditions for this medication, such as pain.”
He says pain is one of the most predominant symptoms patients of a wide variety of conditions including MS live with from globally, and there have been few game-changing drugs in the pharmaceutical market to help treat it.
There is no cure for MS, but current treatments work to speed recovery from attacks, slow disease progression and manage symptoms, according to the Mayo Clinic. The most common treatments used to manage symptoms are physical therapy, muscle relaxants and medications to reduce fatigue, depression and pain.
The Phase 1 trial of the gum is slated to begin in the second quarter of 2016. Though medical marijuana is legal in 23 states and the District of Columbia, it is classified on the federal level as a schedule I drug, which gives it the same illegal status as heroin and LSD and is considered to have no accepted medical use.
While America’s Food and Drug Administration has yet to approve any product containing cannabis, it has approved Marinol — which contains dronabinol, a synthesized form of THC — for anorexia, chemotherapy and AIDS patients. The FDA’s website says it will continue to assess the effectiveness of marijuana for medical use, and will work with companies on medical cannabis research.
If the gum is approved by the FDA, it could be available in all 50 states, even if they have not legalized medical marijuana. “That’s why we’re going through the FDA,” Anastassov says. “There’s no ambiguity as to where it’s legal.”
Source: Market Watch Copyright ©2015 MarketWatch, Inc (27/08/15)
Effects of cannabis on cognition in patients with MS: A psychometric and MRI study.
OBJECTIVE: To determine functional and structural neuroimaging correlates of cognitive dysfunction associated with cannabis use in multiple sclerosis (MS).
METHODS: In a cross-sectional study, 20 subjects with MS who smoked cannabis and 19 noncannabis users with MS, matched on demographic and neurologic variables, underwent fMRI while completing a test of working memory, the N-Back. Resting-state fMRI and structural MRI data (lesion and normal-appearing brain tissue volumes, diffusion tensor imaging metrics) were also collected. Neuropsychological data pertaining to verbal (Selective Reminding Test Revised) and visual (10/36 Spatial Recall Test) memory, information processing speed (Paced Auditory Serial Addition Test [2- and 3-second versions] and Symbol Digit Modalities Test), and attention (Word List Generation) were obtained.
RESULTS: The cannabis group performed more poorly on the more demanding of the Paced Auditory Serial Addition Test tasks (i.e., 2-second version) (p < 0.02) and the 10/36 Spatial Recall Test (p < 0.03). Cannabis users had more diffuse cerebral activation across all N-Back trials and made more errors on the 2-Back task (p < 0.006), during which they displayed increased activation relative to nonusers in parietal (p < 0.007) and anterior cingulate (p < 0.001) regions implicated in working memory. No group differences in resting-state networks or structural MRI variables were found.
CONCLUSIONS: Patients with MS who smoke cannabis are more cognitively impaired than nonusers. Cannabis further compromises cerebral compensatory mechanisms, already faulty in MS. These imaging data boost the construct validity of the neuropsychological findings and act as a cautionary note to cannabis users and prescribers.
Pavisian B1, Macintosh BJ, Szilagyi G, Staines RW, O'Connor P, Feinstein A.
Sources: Neurology. 2014 Apr 30. [Epub ahead of print] & Pubmed PMID: 24789863 (06/05/14)
Cannabis may help with some MS symptoms(29/04/14)
Cannabis sprays and tablets can improve some symptoms of multiple sclerosis, a study shows. But the effect of cannabis on epilepsy and other brain conditions is less clear, and side effects are common.
What do we know already?
Cannabis (also called marijuana) contains around 60 chemicals that affect the brain. Some of these chemicals cause the ‘high’ that people get when they use cannabis as an illegal drug. But these chemicals can also have other effects, which may be helpful for conditions that affect the brain and nervous system, such as multiple sclerosis (MS), Parkinson’s disease, and epilepsy.
Some people smoke cannabis to help with these conditions. Researchers have also developed mouth sprays and tablets with cannabis extracts. Sprays and tablets don’t have some of the health risks associated with smoking cannabis, such as lung diseases.
However, it’s not clear how well any of these forms of cannabis work for people with these medical conditions, as studies have had different results.
How was the new study done?
Researchers searched for the best studies done so far on the effects of cannabis on several conditions affecting the brain and nervous system. These included multiple sclerosis, Huntington’s disease, Tourette’s syndrome, cervical dystonia (abnormal neck movements), and epilepsy. They also searched for studies on using cannabis to help with the movement problems (called dyskinesias) caused by treatment for Parkinson’s disease. They then summarised the studies’ results, to see what conclusions they might draw.
What does the new study say? The researchers found 34 studies in total. Several of these looked at using cannabis for multiple sclerosis. Overall, they found that cannabis sprays and tablets improved some symptoms, including twitching muscles (spasms) and some types of pain (such as pain related to spasms). Cannabis sprays also seemed to help with bladder problems causing people to urinate often. However, cannabis sprays and tablets did not help with tremors (this is when a part of the body shakes).
There wasn’t enough research to say whether cannabis treatments might help with Huntington’s disease, Tourette’s syndrome, cervical dystonia, and epilepsy. However, the research did suggest that cannabis tablets do not help with movement problems caused by treatment for Parkinson’s disease.
Most of the studies looked at taking cannabis by sprays or tablets. There were few useful studies looking at whether smoking cannabis in pipes or cigarettes helped with symptoms.
Many people had side effects when using cannabis. These included weakness, feeling sick, mood changes, dizziness, fatigue, thoughts of suicide, and hallucinations. Overall about 7 in every 100 people using cannabis stopped their treatment because of side effects, compared with 2 in every 100 people using a dummy (placebo) treatment.
Studies also suggested that people with multiple sclerosis were more likely to have a worsening of their thinking abilities (cognitive declines) if they used cannabis.
How reliable is the research?
This review of studies should provide an accurate summary of what the current research tells us. The findings on using cannabis tablets and sprays for multiple sclerosis should be reliable, as these were based on several good-quality studies.
However, we need much more research to know whether cannabis treatments are effective and safe for the other conditions. We also need studies that compare cannabis with other treatments for these conditions.
What does this mean for me?
If you have multiple sclerosis, these findings suggest that cannabis sprays and tablets may improve some of your symptoms. But you need to weigh these possible improvements against the chance of side effects. It is also illegal to possess most kinds of cannabis in the UK, although a cannabis spray called Sativex is available on prescription.
If you have epilepsy, Huntington’s disease, Tourette’s syndrome, or cervical dystonia, we don’t yet have enough research to know whether cannabis treatments are helpful or safe. However, if you have movement problems caused by treatment for Parkinson’s disease, studies do suggest that cannabis tablets are unlikely to help.
Source: WebMD ©2009-2014 WebMD UK Limited and Boots UK Limited (29/04/14)
AAN endorses cannabis for MS(27/03/14)
The American Academy of Neurology has issued new evidence-based complementary and alternative medicine guidelines for multiple sclerosis.
HealthDay News -- The American Academy of Neurology is recommending oral cannabis extract to help ease spasticity symptoms and pain in patients with multiple sclerosis, along with other therapies, in new evidence-based complementary and alternative medicine (CAM) recommendations.
Vijayshree Yadav, MD, of the Oregon Health & Science University in Portland, and other members of the AAN's Guideline Development Subcommittee, conducted a literature search to develop the recommendations, which are published online in Neurology.
Clinicians may offer oral cannabis extract (Level A) or tetrahydrocannabinol (Level B) for spasticity symptoms and pain (excluding central neuropathic pain), but should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term; Level C).
Sativex oromucosal cannabinoid spray (nabiximols) can be suggested for spasticity symptoms, pain and urinary frequency (Level B), but clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Furthermore, the spray is not currently FDA-approved and is unavailable in the United States, the researchers noted.
"In the United States, caution should be exercised with regard to extrapolation of results of trials of standardized oral cannabis extracts (which are unavailable commercially) to other nonstandardized, nonregulated cannabis extracts (which may be commercially available in states with medical marijuana laws)," Yadav and colleagues wrote.
Magnetic therapy is probably effective for fatigue, but probably ineffective for depression (Level B). Among common supplements, clinicians can counsel patients that fish oil is probably ineffective for relapses, disability, fatigue, magnetic resonance imaging lesions, and quality of life (Level B). Ginkgo biloba is ineffective for cognition (Level A), but possibly effective for fatigue (Level C). Reflexology is possibly effective for paresthesia (Level C).
Possibly ineffective therapies (Level C) include Cari Loder for disability, depression and fatigue, and bee sting therapy for relapses, disability, fatigue and lesion burden/volume.
"Clinicians should exercise caution regarding standardized versus nonstandardized cannabis extracts and overall CAM quality control/nonregulation," the researchers wrote. "Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown."
Reference 1.Yadav V et al. Neurology. 2014; 82(12): 1083-1092.
Source: Copyright © 2014 Haymarket Media, Inc. All Rights Reserved (27/03/14)
Medical marijuana may be useful in treating chronic pain and spasticity but less effective for other conditions, according to the results of a review published in the Journal of the American Medical Association.
The researchers singled out 79 clinical trials for inclusion in their analysis. The studies tested the effects either of medical marijuana itself or drugs that contain plant-derived or synthetic compounds found in marijuana, including studies of dronabinol, a U.S. Food and Drug Administration-approved medication that contains synthetic tetrahydrocannabinol. The authors said that they found and included only two studies that evaluated medical marijuana itself, rather than a derivative medication.
The review revealed moderate-quality evidence to support medical marijuana use in treating chronic pain. The evidence also showed that the medications could help multiple sclerosis patients who suffer from spasticity. The researchers found low-quality evidence for the drugs' use in treating sleep disorders; nausea or vomiting related to chemotherapy; for producing weight gain in people with HIV; or for reducing symptoms of Tourette syndrome.
"There is evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity," lead author Penny Whiting, PhD, a senior research fellow at the University of Bristol told HealthDay.
"However, this needs to be balanced against an increased risk of side effects such as dizziness, dry mouth, nausea, sleepiness, and euphoria."
Source: Neurology Advisor Copyright © 2015 Haymarket Media, Inc (25/06/15)
Tags: MS, multiple sclerosis, cannabis, Medical marijuana, chronic pain, spasticity, research
Researchers in Spain have conducted a landmark study to shed light on how marijuana reduces the activity of motor neurons that lead to symptoms such as muscle weakness in people with MS.
Researchers at the University of Cadiz, led by Professor Bernardo Moreno, used synthetic analogues of the psychoactive compounds of marijuana to see how they affected motor neurons.
They looked, in particular, at movements of the tongue and how they responded to the drug.
'During the investigation, we used an animal model in which we studied the alterations produced by synthetic cannabinoids on the activity of the motor neurons,' the researchers wrote.
'In doing so, we discovered that these psychoactive compounds inhibit the information that reaches these neurons via the synapses.
'In other words, cannabinoids hinder the transmission of information between neurons.'
All of this could lead to problems speaking, breathing and swallowing food.
But the same reaction could also explain the beneficial effects that marijuana has on people with neurodegenerative diseases such as multiple sclerosis.
The scientists say that by reducing motor neuron activity, people with multiple sclerosis may have temporary relief from their symptoms.
Source: Daily Mail Online © Associated Newspapers Ltd 2015 (24/02/15)
The American Academy of Neurology (AAN) is calling for more research on the use of medical marijuana for brain, spine and nervous system disorders in a new position statement released by the AAN, the world’s largest association of neurologists with more than 28,000 members.
“The current medical marijuana legislation being passed by policymakers across the country, which promotes marijuana-based products as treatment options for various brain and nervous system disorders, is not supported by high-level medical research,” said position statement author Anup Patel, MD, with Nationwide Children’s Hospital in Columbus, Ohio, and a member of the AAN. “There may be some safety concerns for marijuana-based products, especially for long-term use in patients with these diseases, as to date it has not been well-studied.”
The AAN supports the reclassification of marijuana-based products by the federal government from their current status as a Schedule I drug to improve access for study of marijuana or cannabinoids under approved research protocols. The AAN does not advocate for the legalization of marijuana-based products for use in brain and nervous system disorders at this time, Patel stated, as further research is needed to determine the benefits and safety of such products.
This is especially important in the cases of people with underlying brain disorders and in children whose developing brains may be more vulnerable to the toxic effects of marijuana, according to the position statement. “We recognize that there may be potential use for these agents in the treatment of some brain and nervous system disorders, but there is not sufficient evidence to make any definitive conclusions regarding the effectiveness of marijuana-based products for many neurologic conditions at this time,” Patel said. In March 2014, the AAN published a guideline on complementary alternative therapies, such as medical marijuana, to treat multiple sclerosis (MS).
In April 2014, the AAN published a systematic review on the efficacy and safety of medical marijuana in selected brain and nervous system disorders, such as epilepsy, Parkinson’s disease, MS and Tourette syndrome. The position statement also notes that many cannabis preparations used in studies are not available in the United States. “It is not appropriate to extrapolate the results of trials of standardised preparations to other, non-standardised, non-regulated cannabis products that may be commercially available in states with laws supporting the use of medical marijuana,” Patel said. The position statement is available at www.aan.com.
The American Academy of Neurology, an association of more than 28,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer’s disease, stroke, migraine, multiple sclerosis, concussion, Parkinson’s disease and epilepsy.
Source: HealthCanal (18/12/14)