GW Pharma aiming for FDA approval for CBD drug this year, again

British cannabis company GW Pharmaceuticals is hoping the U.S. Food and Drug Administration will sign off on its CBD-based epilepsy treatment, Epidiolex, as soon as this year.

According to The Washington Post, GW is hoping to get the green light from the FDA to classify Epidiolex as a prescription drug, despite the fact it’s derived from marijuana.

To that end, GW released results this week from a scientific study, which, the company argues, proves the drug is effective in treating patients with Lennox-Gastaut Syndrome, a form of epilepsy.

The study found that over a 14-week period, 44% of study participants saw a “significant reduction” in the number of seizures they suffered, the Post reported.

GW Pharmaceuticals has been trying to gain FDA approval for Epidiolex for over two years but has had no success thus far.

The company even organized two separate clinical trials in 2016 – one was released in March and another in September.

Both found that Epidiolex can be effective for epileptic children who suffer from Dravet Syndrome, another form of intractable epilepsy.

GW had hopes in early 2016 of starting widespread U.S. sales of Epidiolex by the end of 2017.

Though that didn’t come to fruition, the company is aiming to begin sales in the second half of 2018, according to the Post.

After the two trials results were released in 2016, GW Pharmaceuticals’ stock price soared.

The company is traded on the Nasdaq under the ticker symbol GWPH.

2 comments on “GW Pharma aiming for FDA approval for CBD drug this year, again
  1. Christopher Simmons on

    The USA FDA is as corrupted as the DEA. Big Pharma has over $150 Million in lobbying money on Capitol Hill to keep cannabis illegal on Schedule 1 of the DEA. Corrupt US politicians like Jefferson Beauregard Sessions and obese Chris Christie are in bed with Big Pharma and spend their undying efforts to keep this medicinal plant “illegal “! A big chunk of the DEA’s budget would be slashed if they de Scheduled or removed cannabis, so that cannot happen!!!!!

    Reply
  2. John Antonellis on

    What’s really difficult to understand is how the DEA can not de-schedule marijuana after The National Academies of Sciences, Engineering and Medicine released a report 1/17 which upon review of the ailment chronic pain it found strong evidence that it has a medicinal benefit. These agencies have to be accountable to someone, thought it was the citizens of this country.

    Reply

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