A Food and Drug Administration (FDA) panel has given the green light to a marijuana-derived prescription medication that could be used to treat rare forms of epilepsy. Given that the panel's Dr. John Mendelson has called this "a breakthrough drug" for an often debilitating disease, many patients will likely embrace it.
The acceptable safety risks included liver injury, which it said can be managed and monitored.
The FDA will reportedly decide by the end of June if it'll approve Epidiolex. 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.
While 30 states already allow for the use of cannabis to treat a variety of ailments such as chronic pain, post-traumatic stress disorder, arthritis and epilepsy, the plant is not FDA-approved.
The FDA has previously approved synthetic versions of some chemicals found in marijuana for specific objective including cancer pain relief.
Several patients and parents at Thursday's meeting spoke about the benefits of Epidiolex.
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During the public hearing to review Epidiolex, 16-year-old Sam Vogelstein of Berkeley, California, told the panel, "I had seizures for 10 years. there were times I had seizures 100 times a day".
"I just went to South Africa for two weeks without my parents on a school trip", said Vogelstein, who lives in Berkeley, Calif.
It's not yet clear why the medicine reduces seizures.
The medicine's active ingredient is cannabidiol - a chemical found in cannabis.
CBD oil is now sold online and in small shops across the USA, but its legal status remains murky.
Cannabidiol, also called CBD, does not produce a high, unlike tetrahydrocannabinol, or THC.
Bottom line looks stellar for the drug maker from where Piros is standing: "The overall tone of the meeting was positive, with the FDA having identified no obstacles to approval". Executives for the British drugmaker GW Pharmaceuticals say their goal is to provide a more standardized, research-backed version. The varying levels of leftover THC that were observed would be something the DEA would consider in an assessment of the drug's potential for abuse should the drug win approval, Barbara Carreno, a DEA spokesperson, confirmed to BioPharma Dive. Wall Street analysts estimate it could cost more than $25,000 per year.