The FDA finally weighs on marijuana, and it's a Go – The Motley Fool

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There has been a debate about the use of marijuana in epileptic patients since the use of a special strain of marijuana made by the Stanley Brothers has attracted the attention media in 2013 to help control seizures in Charlotte, a Colorado child with Dravet syndrome. Until now, the Food and Drug Administration (FDA), the regulator charged with reviewing scientific data and approving or rejecting drugs based on their merits, had remained silent on the issue. Use of marijuana in epileptic patients. That changed this week when he gave a boost to GW Pharmaceuticals & nbsp; (NASDAQ: GWPH) Epidiolex, a purified oral formulation of cannabidiol (CBD).

Big Marijuana News

Because the FDA is a scientific organization that approves drugs based on their proven ability to be safe and effective in well-controlled trials, it is a great validation that CBD can help epileptic patients.

Marijuana Growing in a GW The FDA has not approved the use of CBD purchased in medical marijuana dispensaries, but its nodding allows doctors to prescribe and patients to take Epidiolex at the same time. Nationwide, without fear of reprisal. even in states where marijuana is still illegal. </p> <p> One of the 60 cannabinoids found in the marijuana plant, CBD is the same chemical on which the Stanley brothers focused when developing Charlotte's web from hemp. It is also the main cannabinoid found in other varieties of marijuana that have been designed for medical use, including Katelyn Faith, Harlequin and Remedy. </p> <p> Unlike tetrahydrocannabinol (THC), CBD is not psychoactive, so it does not cause euphoric. In contrast, CBD appears to control seizures by interacting with several neurotransmitters and neuromodulators. </p> <p> It is not fully understood why CBD treats epilepsy so effectively, but research from GW Pharmaceuticals suggests that the benefits of CBD are the result of an anticonvulsant effect a number of endogenous systems including, but without limiting it, neuronal inhibition (synaptic and extrasynaptic GABA channels), intracellular calcium modulation (TRPV, VDAC, GPR55) and possible anti-inflammatory effects (adenosine). "</p> <p> Regardless of its mechanism of action, the ability of Epidiolex to reduce seizures in epileptics is remarkable .In clinical trials involving hundreds of patients with Dravet syndrome and Lennox syndrome -Gastaut, two types of infantile epilepsy, patients saw a 40% decrease in seizures </p> <h2> GW Pharmaceuticals conducted research on marijuana.The medicine has been blended since the 1990s. At present, his attempts to prove the efficacy of marijuana-derived drugs have been mitigated. </p> <p> The company has obtained European approval for a THC-based drug, Sativex, to control muscle spasms in patients with multiple sclerosis.However, large placebo-controlled trials in cancer pain failed to prove Sativex in 2015. </p> <p> Because Sativex was not Not yet approved in the United States, Epidiolex will be the first marijuana drug available in America. It remains to be seen how widespread the use of Epidiolex will be, but an argument can be made that it will be a bestseller. </p> <p> Epidiolex is initially approved only for Dravet syndrome and Lennox-Gastaut syndrome; However, doctors may prescribe FDA-approved drugs off-label, so Epdiolex could gain more widespread use in epilepsy. If so, this could result in a windfall for GW Pharmaceuticals and its investors. </p> <p> 2.2 million Americans suffer from epilepsy, including 470,000 children, and seizures are poorly controlled in about one third of patients, despite the widespread use of </p> <div class= A researcher in a lab coat studies a marijuana plant in a greenhouse

SOURCE OF IMAGE: GETTY IMAGES.

What to look at now

The Drug Enforcement Agency (DEA) still classifies marijuana as a drug. Schedule I Drug But following this approval, Epidiolex could get more favorable programming, and if it does, it could reduce barriers to access. The DEA has a period of 90 days to issue a final final rule regarding the programming of Epidiolex; Although it is impossible to say what the agency will do, GW Pharmaceuticals would consider an IV schedule decision as a big win. A Schedule II decision would be a waste, because Schedule II drugs can not be so easily filled.

Overall, the approval of Epidiolex is a big step forward for the medical marijuana movement. He is likely to gain support from doctors and patients in this difficult-to-treat patient population, and he helps companies run their own clinical trials in other indications. However, the size of Epidiolex will not be known for a while. Investors may want to approach this marijuana stock with cautious optimism

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