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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, seve


... that was back in June 2018 and still the only marijuana drug approved by the FDA 1/.

note: It is estimated that $18 million was spent and a five years effort by GW Pharmaceuticals plc to rigorously test Epidiolex to obtain FDA approval. The standards used by the FDA will also apply for approval of any CBD Hemp drug. Current unsubstantiated claims by marketeers of CBS benefits will not stand the test of effectiveness unless the FDA signs off.

1/ The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CBD Hemp will never be an effective drug without the FDA seal of approval. The noise from Wall Street, the Peanut Gallery and the other kind claiming that CBD hemp is safe from FDA meddling because of the 2018 Farm Bill are lost in the sauce.

Look at history for the truth.

In June 2018, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. CBD is a chemical component of the Cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms). Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others.

Lennox-Gastaut syndrome begins in childhood. It is characterized by multiple types of seizures. People with Lennox-Gastaut syndrome begin having frequent seizures in early childhood, usually between ages 3 and 5. More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with Lennox-Gastaut syndrome require help with usual activities of daily living. “The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.” Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.

About the Company .... GW Pharmaceutical plc GWRH $104.85

click https://finance.yahoo.com/quote/GWPH?p=GWPH&.tsrc=fin-srch

GW Pharmaceutical plc , focuses on discovering, developing, and commercializing cannabinoid prescription medicines using botanical extracts derived from the Cannabis plant. Its lead product is Epidiolex, an oral medicine for the treatment of refractory childhood epilepsies, as well as for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms. The company also develops and markets Sativex, an oromucosal spray for the treatment of spasticity due to multiple sclerosis. In addition, it develops various product candidates for the treatment of glioblastoma, neonatal hypoxic-ischemic encephalopathy, and schizophrenia. Further, the company has license and development agreements with Almirall S.A.; Bayer HealthCare AG; Ipsen Biopharm Ltd; and Neopharm Group. It primarily operates in Europe, the United Kingdom, the United States, Canada, and Asia. GW Pharmaceuticals plc was founded in 1998 and is based in Cambridge, the United Kingdom.

GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise. GW has developed an oral formulation of purified cannabidiol (CBD), approved as EPIDIOLEX® in the U.S. by the U.S. Food and Drug Administration (FDA) for seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome, two rare and severe early-onset, drug-resistant epilepsy syndromes. This is the first cannabis plant-derived medicine ever approved by the FDA and it has been rescheduled by the U.S. DEA to a schedule V. The medicine was launched in the US as a prescription medicine by our US operating subsidiary, Greenwich Biosciences Inc., on November 1, 2018. This product has received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX® for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.* GW successfully developed the world’s first prescription medicine derived from the cannabis plant, a complex botanical mixture called Sativex® (delta-9-tetrahydrocannibinol and cannabidiol) in Europe; nabiximols in the US, over ten years ago, which is now approved in over 25 countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop Sativex and is preparing to file and NDA in the United States by the end of 2019.

The company has a deep pipeline of additional clinical stage cannabinoid product candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions.


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