American Academy of Neurology has released some new data on GW Pharmaceuticals’ medical marijuana “investigational medicine Epidiolex® (pure cannabidiol, or CBD)”. The study, the results of which “will be presented at the American Academy of Neurology’s 67th Annual Meeting in Washington, DC, April 18 to 25, 2015″, involved 213 people (toddlers to adults; median age 11) who had severe epilepsy that did not respond to other treatments. The participants had 12 different types of severe epilepsy, including Dravet syndrome and Lennox-Gastaut syndrome.
Of the people who completed the 12 week study, the number of seizures decreased by 54% from beginning to end of the study. Those with Dravet syndrome and Lennox-Gastaut syndrome showed similar improvements.
A total of 12 people (6%) experienced side-effects which made them stop taking the medical marijuana liquid extract medicine. The most common side-effects were “drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent)”.
The study was performed by Dr. Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center and a Fellow of the American Academy of Neurology.
This is a significant step in backing up the abundant anecdotal evidence on the benefits of cannabis and cannabis extracts for those with severe forms of epilepsy.
In just 12 weeks, GW Pharmaceuticals’ Epidiolex® (pure cannabidiol, or CBD) reduced the number of seizures, on average, by half. And this is for patients who weren’t responding to other available treatments.
We need to eliminate the Federal Prohibition on cannabis and open the floodgates of research on this plant. Just from what little research that has been done to date, it’s given hope back to so many who had run out of it long ago.
The Press Relesase from the American Academy of Neurology is quoted below:
Medical Marijuana Liquid Extract May Bring Hope for Children with Severe Epilepsy
WASHINGTON, DC – A medicinal liquid form of marijuana may show promise as a treatment for children with severe epilepsy that is not responding to other treatments, according to a study released today that will be presented at the American Academy of Neurology’s 67th Annual Meeting in Washington, DC, April 18 to 25, 2015.
The study involved 213 people, ranging from toddlers to adults, with a median age of 11 who had severe epilepsy that did not respond to other treatments. Participants had Dravet syndrome and Lennox-Gastaut syndrome, epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy.
The participants were given the drug cannabidiol, a component of marijuana that does not include the psychoactive part of the plant that creates a “high.” The drug is a liquid taken daily by mouth. Participants all knew they were receiving the drug in the open-label study, which was designed to determine whether the drug was safe and tolerated well.
Researchers also measured the number of seizures participants had while taking the drug. For the 137 people who completed the 12-week study, the number of seizures decreased by an average of 54 percent from the beginning of the study to the end. Among the 23 people with Dravet syndrome who finished the study, the number of convulsive seizures had gone down by 53 percent by the end of the study. For the 11 people with Lennox-Gastaut syndrome who finished the study, there was a 55 percent reduction in the number of atonic seizures, which cause a sudden loss of muscle tone.
A total of 12 people, or 6 percent, stopped taking the drug due to side effects. Side effects that occurred in more than 10 percent of participants included drowsiness (21 percent), diarrhea (17 percent), tiredness (17 percent) and decreased appetite (16 percent).
Study author Orrin Devinsky, MD, of New York University Langone Comprehensive Epilepsy Center and a Fellow of the American Academy of Neurology, said that these are early findings and larger, placebo-controlled, double-blind trials are needed to measure the effectiveness of the drug. “So far there have been few formal studies on this marijuana extract,” Devinsky said. “These results are of great interest, especially for the children and their parents who have been searching for an answer for these debilitating seizures.”
The study was supported by GW Pharmaceuticals.
To read the AAN’s systematic review regarding epilepsy and brain disorders, please visit http://www.neurology.org/content/82/17/1556.full. To learn more about epilepsy, please visit www.aan.com/patients.
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.
And this is the Press Release from GW Pharmaceuticals:
GW Pharmaceuticals Notes New Epidiolex Data Released by the American Academy of Neurology
London, UK, 13 April 2015: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today noted that the American Academy of Neurology (AAN) issued a press release today on GW’s investigational medicine, Epidiolex® (pure cannabidiol, or CBD).
Data in the AAN release are from physician-led FDA authorized Epidiolex “expanded access” programs for children and young adults with treatment-resistant epilepsy that have exhausted available treatment options. The data provide treatment effect information on a total of 137 patients who have at least 12 weeks of Epidiolex exposure. Safety data is provided on 213 patients, representing these 137 patients plus additional patients still in their first 12 weeks of treatment.
Additional data will be presented in a poster at the AAN Annual Meeting on 22 April at 6.15pm EDT, at which time GW will make an additional disclosure.
“We are pleased that the American Academy of Neurology has chosen to highlight the importance of the Epidiolex expanded access data and look forward to more detailed information at the forthcoming AAN Annual Meeting being made available by the physicians leading this program,“ stated Justin Gover, GW’s Chief Executive Officer.
FDA authorized expanded access programs facilitate access to investigational drugs for treatment use in patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives. Patients in the Epidiolex expanded access program included those with Dravet syndrome and Lennox-Gastaut syndrome (LGS), epilepsy types that can lead to intellectual disability and lifelong seizures, as well as 10 other types of severe epilepsy. Many have extreme and rare forms of epilepsy including several patients with major congenital structural brain abnormalities.
In parallel with the expanded access program, GW is advancing its formal clinical development program in order to seek FDA approval for Epidiolex in the treatment of Dravet syndrome and Lennox-Gastaut syndrome, two rare and catastrophic forms of epilepsy. GW recently commenced the first of two Phase 3 trials in Dravet syndrome and expects to commence Phase 3 trials in LGS in the second quarter of 2015.
The full text of the AAN announcement is available at: https://www.aan.com/pressroom
Note regarding expanded access studies
Expanded access studies are uncontrolled, carried out by individual investigators, and not typically conducted in strict compliance with Good Clinical Practices, all of which can lead to a treatment effect which may differ from that in placebo-controlled trials. These studies provide only anecdotal evidence of efficacy for regulatory review. These studies contain no control or comparator group for reference and these patient data are not designed to be aggregated or reported as study results. Moreover, data from such small numbers of patients may be highly variable. Information obtained from these studies, including the statistical principles that we have chosen to apply to the data, may not reliably predict data collected via systematic evaluation of the efficacy in company-sponsored clinical trials or evaluated via other statistical principles that may be applied in those trials. Reliance on such information to design our clinical trials may lead to Phase 2 and 3 trials that are not adequately designed to demonstrate efficacy and could delay or prevent our ability to seek approval of Epidiolex. Expanded access programs provide supportive safety information for regulatory review. Physicians conducting these studies may use Epidiolex in a manner inconsistent with the protocol, including in children with conditions beyond those being studied in GW-sponsored trials. Any adverse events or reactions experienced by subjects in the expanded access program may be attributed to Epidiolex and may limit our ability to obtain regulatory approval with labeling that we consider desirable, or at all.
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company’s investigational drug Epidiolex®, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®, Epidiolex®, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes Sativex in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer, as well as compounds in Phase 1 and 2 trials for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
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