US: First FDA-approved marijuana drug available across all US states
The first marijuana-based medication approved by the US Food and Drug Administration (FDA), Epidiolex, is now available as prescription medicine across all 50 US states. The drug was approved by the FDA in June. In September, the US Department of Justice classified the drug as a Schedule V substance, thereby clearing its use. Ironically, marijuana remains a Schedule I substance. Here's more.
FDA commissioner expresses support for marijuana-based drugs
"The FDA will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and stand ready to work with product developers who are interested in bringing patients safe and effective, high quality products," said FDA Commissioner Dr. Scott Gottlieb.
What is Epidiolex used for?
Epidiolex is a twice-daily oral medication for two particular epileptic syndromes. It can be used to treat Dravet Syndrome, a rare, genetic brain dysfunction that sets in after the first year of life, and Lennox-Gastaut Syndrome, a form of epilepsy wherein multiple types of seizures start affecting children from an early age, usually 3-5 years. Epidiolex can be prescribed to patients aged two years and above.
Epidiolex is an effective drug, not a miracle drug
Epidiolex, manufactured by GW Pharmaceuticals, was approved by the FDA after "adequate and well-controlled clinical trials" demonstrated its efficacy. The large-scale trials demonstrated that that Epidiolex, on an average, reduced convulsive seizures by about 25% to 28%, compared to a placebo. Researchers said that some patients saw dramatic improvements, most patients saw moderate improvement, while some patients saw no improvement.
Clinical trials lead investigator points out limitations
"...It's not a miracle drug. It's an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it's not a miracle cure," said Dr. Orin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone Health, and lead investigator of clinical trials.
Epidiolex is expensive, but should fall under insurance
According to GW Pharmaceuticals, the average list price for Epidiolex is around $32,000 a year. While that's expensive, the company hopes that the cost of procuring the drug will be covered by most insurance companies. As far as side effects go, Epidiolex is better than its counterparts, and its side effects include sleepiness, decreased appetite, diarrhea and an increase in liver enzymes.
