There was a dispute over the use of marijuana in epileptic patients, as the use of a special marijuana strain from the Stanley Brothers in 2013 found widespread media attention to the seizures in Charlotte, a Colorado child with Dravet's syndrome, to fight off epilepsy.
So far, the Food and Drug Administration (FDA), the regulator responsible for the verification of scientific data and licensing or rejecting drugs on their merits, had remained on the use of marijuana in epilepsy patients , That changed this week when GW Pharmaceuticals (NASDAQ: GWPH) gave Epidiolex, a purified oral formulation of cannabidiol (CBD) a thumbs-up.
Great Marijuana News
Because the FDA is a science-based organization that approves drugs because of its proven ability to be safe and effective in well-controlled trials, the OK is a great validation that CBD can help epileptic patients ,
CBD is one of 60 cannabinoids found in the marijuana plant. It's the same chemical that the Stanley Brothers focused on making hemp from Charlotte's Web. It is also the major cannabinoid in other marijuana strains that have been developed for medicinal purposes, including Katelyn Faith, Harlequin and Remedy.
Unlike tetrahydrocannabinol (THC), CBD is not psychoactive, so it causes no euphoric highlights. Instead, CBD seems to control seizures by interacting with multiple neurotransmitters and neuromodulators.
It is not fully understood why CBD treats epilepsy so effectively, but GW Pharmaceuticals research suggests CBD benefits as a "cumulative anticonvulsant effect, modulating a number of endogenous systems, including but not limited to neuronal inhibition (synaptic and extrasynaptic GABA). Channels), modulation of intracellular calcium (TRPV, VDAC, GPR55) and possible anti-inflammatory effects (adenosine). "
Regardless of its mechanism of action, Epidiolex's ability to reduce seizures in epileptics is remarkable. In clinical studies with hundreds of patients with Dravet's syndrome and Lennox-Gastaut syndrome, two types of childhood epilepsy, patients saw a drop in seizures by about 40%.
GW Pharmaceuticals Researched About Marijuana Since the 1
990s However, the efficacy of marijuana-containing medications has not been clearly demonstrated for years.
The company received European approval for a THC-based drug called Sativex to control muscle spasms in patients with multiple sclerosis. However, large placebo-controlled cancer pain trials in 2015 did not support proof of Sativex's efficacy.
Since Sativex is not yet approved in the US, Epidiolex will be the company's first marijuana drug available in America. It remains to be seen how far the use of Epidiolex will increase, but it can be argued that it will be a bestseller.
Epidiolex is initially approved for Dravet syndrome and Lennox-Gastaut syndrome only; However, physicians may prescribe FDA-approved drugs off-label so that Epdiolex could gain broader use in epilepsy. If so, it could turn gold into a goldmine for GW Pharmaceuticals and its investors.
There are 2.2 million Americans suffering from epilepsy, including 470,000 children, and seizures are inadequately controlled in about one-third of patients despite widespread use Antiepileptic drugs
The Drug Enforcement Agency (DEA) still executes marijuana as a Schedule I drug. But after this approval, Epidiolex could ensure more favorable planning and, if so, could reduce access barriers. The DEA has 90 days to issue a provisional final rule regarding the scheduling of Epidiolex; While there's nothing to say what the agency will do, GW Pharmaceuticals would consider a Schedule IV decision a big win. A decision on Schedule II would be a loss, as the Schedule II drugs are not that easy to replenish.
Overall, the approval of Epidiolex is a major advance for the medical marijuana movement. It is likely to gain support among physicians and patients in this difficult-to-treat patient population, and it paves the way for more companies to conduct their own clinical trials in other indications. How big a commercial hit for Epidiolex is, however, will not be known for a long time. Investors could cautiously approach this marijuana stock with cautious optimism.