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Pharmaceutical Company Gets FDA Approval For Marijuana Plant Derived Drug

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FDA medical marijuana epidiolex gw pharmaceuticalsHow do you feel about the pharmaceutical industry entering the medical marijuana scene? Do you think that a pharmaceutical company can produce better medical marijuana products than what are currently out there? Are you scared of a pharmaceutical takeover of the medical marijuana industry? A major pharmaceutical company received approval this week from the Food and Drug Administration (FDA) for a plant derived medicine called Epidiolex. Do you think this is good or bad? Do you think it will increase support for cannabis research by our federal government? Below is a press release from GW Pharmaceuticals, the creator of Epidiolex:

GW Pharmaceuticals plc (AIM: GWP, Nasdaq: GWPH, “GW”) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Epidiolex®, our product candidate that contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome. Epidiolex is an oral liquid formulation of a highly purified extract of CBD, a non-psychoactive molecule from the cannabis plant. Following receipt of this orphan designation, GW anticipates holding a pre-IND meeting with the FDA in the near future to discuss a development plan for Epidiolex in Dravet syndrome.

Dravet syndrome is a rare pediatric epilepsy syndrome with a distinctive but complex electroclinical presentation. Onset of Dravet syndrome occurs during the first year of life with clonic and tonic-clonic seizures in previously healthy and developmentally normal infants. Prognosis is poor and patients typically develop intellectual disability and life-long ongoing seizures. There are approximately 5,440 patients with Dravet in the United States and an estimated 6,710 Dravet patients in Europe. These figures may be an underestimate as this syndrome is reportedly underdiagnosed.

In addition to GW’s clinical development program for Epidiolex in Dravet syndrome, which is expected to commence in 2014, GW has also made arrangements to enable independent U.S. pediatric epilepsy specialists to treat high need pediatric epilepsy cases with Epidiolex immediately. To date in 2013, a total of seven “expanded access” INDs have been granted by the FDA to U.S. clinicians to allow treatment with Epidiolex of approximately 125 children with epilepsy. These children suffer from Dravet syndrome, Lennox-Gastaut syndrome, and other pediatric epilepsy syndromes. GW is aware of further interest from additional U.S. and ex-U.S. physicians to host similar INDs for Epidiolex. GW expects data generated under these INDs to provide useful observational data during 2014 on the effect of Epidiolex in the treatment of a range of pediatric epilepsy syndromes.

“I, together with many colleagues in the US who specialize in the treatment of childhood epilepsy, very much welcome the opportunity to investigate Epidiolex in the treatment of Dravet syndrome. The FDA’s timely approval of the orphan drug designation for Epidiolex in Dravet syndrome is a key milestone that comes after many years of reported clinical cases that suggest encouraging evidence of efficacy for CBD in this intractable condition,” stated Dr. Orrin Devinsky, Professor of Neurology, Neurosurgery and Psychiatry in New York City. “With GW now making plans to advance Epidiolex through an FDA development program, we have the prospect for the first time of fully understanding the science of CBD in epilepsy with a view to making an appropriately tested and approved prescription medicine available in the future for children who suffer from this debilitating disease.”

“GW is proud to be at the forefront of this important new program to treat children with Dravet Syndrome and potentially other forms of intractable childhood epilepsy. For families in these circumstances, their lives are significantly impacted by constant and often times very severe seizures in children where all options to control these seizures have been exhausted,” stated Dr. Stephen Wright, GW’s R&D Director. “GW intends to advance a full clinical development program for Epidiolex in Dravet syndrome as quickly as possible, whilst at the same time helping families in the short term through supporting physician-led INDs to treat intractable cases. Through its efforts, GW aims to provide the necessary evidence to confirm the promise of CBD in epilepsy and ultimately enabling children to have access to an FDA-approved prescription CBD medicine.”
“This orphan program for Epidiolex in childhood epilepsy is an important corporate strategic priority for GW. Following receipt of today’s orphan designation, GW now intends to commence discussions with the FDA regarding the US regulatory pathway for Epidiolex,” stated Justin Gover, GW’s Chief Executive Officer. “GW intends to pursue this development in-house and retains full commercial rights to Epidiolex.”

About Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition – generally a disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication.

About GW Pharmaceuticals

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 22 countries. Sativex is also 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 in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.

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72 Comments

  1. “A lie can travel half way around the world while the truth is putting on its shoes.” Charles Spurgeon, brainyquote

  2. Kushington Budz III on

    Join the campaign to abolish garbage weed The No MiD movement,.. IG kushingtonbudziii

  3. Since there has never been a fatal drug overdose with Marijuana, my only thought is that the parmaceutical people will make a dose that could kill! Keep it simple and let those grow it or purchase it via a simple, yet easy interface with the farmers or whatever. I’m sure the Drug Companies can make an effective pill!

    Jack

  4. It takes forever to get a book published – if at all. Your blog addresses this? I’ll have to check it out.

  5. If the pharmaceutical companies can produce a controlled dosage, high-purity medication based on CBD to treat a specific disease or symptom, that’s great! They will probably have big, immaculate greenhouses that produce plants we would consider useless. I believe recreational cannabis will be more like the wine business than big pharma.

  6. This is Great! I’m glad the FDA has approved this medication and hopefully this WILL encourage the Feds to look into the possibility that marijuana can be used as medicine.

  7. i’m a neuroscientist who’s studied cannabinoids. They have been doing tons of cannabinoid (not cannabis) research here in the states. They will never do cannabis research because pharmaceuticals are more profitable and easier to regulate. Marijuana has a black market and we can and will grow it ourselves. Thus, they’re going after the bigger market.

  8. The production of more extra-strength and unnatural cannabinoid-based pharmaceuticals will lead to more deaths like Marinol versus none cannabis. Oh, and does anyone remember Rimonabant, the CB1 antagonist sold in Europe as the most effective weight loss drug ever until the found out it caused suicide and depression and pulled it? The entourage effect of multiple cannabinoids, terpenes and flavanols in cannabis enhance bioavailability and prevent overdose. Natural is safer!

  9. There are ways to exponentially boost how much CBD hits your brain from the weed you already smoke or eat. I’m a scientist with years of industry experience with supplements, drug delivery and cannabinoids. I’m outraged that simple, cheap tricks that could reduce the need for expensive, high doses of CBD products are being hidden from the public. I’m trying to get funding to write my book so the sick people who need this medicine can actually afford it (including myself).

  10. Sorry, I don’t understand the comparison. I just wonder what language (if any) the warning labels will carry, as decided upon by the FDA. We will be able to compare any warnings in current cannabis studies of the real thing against whatever warnings the big-pharma brand will carry. Or did you really want to talk about AEDs?

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