FDA Panel’s Approval Of Epilepsy Drug Paves Way For U.S.’s First Cannabis-Derived Prescription Medicine

The New York Times: F.D.A. Panel Recommends Approval Of Cannabis-Based Drug For Epilepsy
A Food and Drug Administration advisory panel on Thursday unanimously recommended approval of an epilepsy medication made with an ingredient found in marijuana. If the agency follows the recommendation, as is expected, the drug would be the first cannabis-derived prescription medicine available in the United States. (Kaplan, 4/19)

The Washington Post: First Marijuana-Derived Drug Poised For FDA Approval After Winning Support From Advisers
The drug, Epidiolex, would be administered in a syrup form and is made from a purified ingredient in cannabis called cannabidiol, or CBD. It is intended to treat severe seizures in children caused by rare forms of epilepsy called Lennox-Gastaut and Dravet syndromes. Most patients with those diseases have uncontrolled daily seizures despite treatment, putting them at high risk for developmental disabilities, serious injury and premature death, the FDA staff said in background materials released this week. (McGinley, 4/19)

The Associated Press: US Experts Back Marijuana-Based Drug For Childhood Seizures
FDA regulators are due to make their decision by late June. Approval would technically limit the drug, called Epidiolex, to patients with hard-to-treat forms of epilepsy. 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. More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. The FDA has approved synthetic versions of another cannabis ingredient for other medical purposes. (Perrone, 4/19)

Stat: Panel Recommends FDA Approval Of Epilepsy Drug Derived From Marijuana
In sometimes emotional testimony, the parents of children with the conditions urged the panel and FDA to get the drug to the market. They described how they have to watch their children constantly, and the horror of their children’s seizures, which can be so violent they break bones. They explained the developmental setbacks their children faced and the problems with other medications and therapies they had tried. “She couldn’t go outside, she couldn’t do anything that other kids do,” said Stephen Carlin, who showed videos of his daughter, Zora, who has Dravet syndrome, having seizures. (Joseph, 4/19)

In other news —

Politico: Schumer To Introduce Bill To Decriminalize Marijuana
Senate Minority Leader Chuck Schumer (D-N.Y.) said on Thursday that he would introduce legislation to decriminalize marijuana at the federal level, marking a significant shift in policy for the Democratic leader and lending the movement to lower government barriers to the drug a powerful ally. (Lima, 4/19)

The New York Times: Turning To Marijuana For A Runners’ High And More
The ultramarathoner Avery Collins, among the fastest in the world, , is not shy about appearing in photographs holding a bong. The first time he tried running after using marijuana, he said, he realized “it allowed me to be very present and not to worry as much about overall times and what’s going on with the run.” Mr. Collins, a 25-year-old from Colorado Springs, is one of a likely legion of athletes who use marijuana as part of their training — although he’s one of the few fast enough to get an endorsement deal from an edibles company. (Miller, 4/20)

The Philadelphia Inquirer: Marijuana Growers Seek To Extinguish Pa.'s Cannabis Research Program
Calling it “disruptive” and “unlawful,” a group of Pennsylvania marijuana growers and retailers wants to snuff out the state’s pioneering research program before it is launched. The first of its kind in the nation, the research program would allow eight of the state’s teaching hospitals to contract with a cannabis producer. (Wood, 4/19)