Wednesday, 18 July, 2018

FDA Approves First Cannabis-Derived Drug For Medical Use

FDA approves first cannabis-based drug The US pharmacies were allowed to sell the drug out of marijuana
Melissa Porter | 26 June, 2018, 22:15

As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.

"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands.

Epidiolex, made by British biopharma company GW Pharmaceuticals, uses purified cannabidiol (CBD), which is one of more than 80 active compounds in the cannabis plant.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017.

A company representative said the list price for the medication had not been set yet. Epidiolex contains only cannibidiol, one of hundreds of molecules found in the marijuana plant, and treats only two extremely rare forms of pediatric epilepsy affecting less than 45,000 children. She says this is a step forward for other families suffering all across the country. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high.

"Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA's drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients", FDA Commissioner Scott Gottlieb, said in a statement today. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.

It's not clear how quickly the drug will be available for prescription.

Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. A bill was introduced to the House a year ago to legalize the use of marijuana, but it has yet to reach the floor for vote. But GW said it expects that the DEA will reschedule CBD within 90 days.

The European Medicines Agency is expected to rule on the therapy in early 2019.