Marijuana-based drug gets positive review from US agency

WASHINGTON (AP) – A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday.

British drugmaker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis – one that doesn’t get users high – as a medication for rare, hard-totreat seizures in children. If successful, the company’s liquid formula would be the first government-approved drug derived from the cannabis plant in the US.

The Food and Drug Administration’s approval would technically limit the treatment to a small group of epilepsy patients. But doctors would have the option to prescribe it for other uses and it could spur new pharmaceutical research and interest into other cannabis-based products. Man-made versions of a different marijuana ingredient have previously been approved for other purposes.

The FDA posted its review of the experimental medication Epidiolex ahead of a public meeting Thursday when a panel of outside experts will vote on the medicine’s safety and effectiveness. It’s a non-binding recommendation that the FDA will consider in its final decision by late June.

Patients taking the treatment had fewer seizures, according to the FDA’s internal review posted online. Scientists concluded that GW Pharmaceutical’s submission “appears to support approval” despite some potential side effects including risks of liver injury.

More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. In 2016, the agency recommended against easing federal restrictions on marijuana. The US continues to classify marijuana as a high-risk substance with no medical use, alongside other illicit drugs like heroin and LSD.

For years, desperate patients and parents have pushed for wider access to medical marijuana products for a host of conditions including pain, posttraumatic stress disorder and epilepsy, with only anecdotal stories and limited studies on their side.

But studies conducted by GW Pharmaceuticals have begun to change that picture.

Across three studies involving more than 500 patients, Epidiolex generally cut the number of monthly seizures by about 40 percent, compared with reductions between 15 and 20 percent for patients taking a dummy medicine.