As expected, the U.S. Food and Drug Administration on Monday approved GW Pharmaceuticals PLC-ADR (NASDAQ: GWPH)'s Epidiolex for the treatment of epilepsy, specifically for people who suffer with Lennox-Gastaut and Dravet syndromes. "Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite now available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal brain waves on EEG (electroencephalogram)".
A statement from the UK-based GW pharmaceutical company said, "First pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs". The drug, Epidiolex, is meant to treat seizures resulting from Dravet syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. These side effects are "sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections". Alan also expects that there will be more CBD products and other medications derived from cannabinoids on the market.
"This is an important medical advance", FDA Commissioner Scott Gottlieb said.More news: Foreign Minister Soini: US departure from UN Human Rights Council 'a setback'
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It does not qualify as medical marijuana as CBD is the relaxant chemical compound in cannabis, as opposed to THC, the element of the drugs that induces the feeling of being high. The drug contains only trace amounts of the psychoactive element THC and does not induce euphoria.
The company has not announced pricing for the drug, but Wall Street analysts previously predicted it could cost as much as $25,000 per year.
Even though there are numerous approved epilepsy drugs, Dr. Devinsky says there's a pressing need for something like Epidiolex because it has a completely different, and better tolerated, formula for patients. "But they're scared because they don't want marijuana", Hanson said. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.
GW Pharma has to wait to sell Epidiolex until the Drug Enforcement Administration decides what restrictions to place on the drug to ensure that it reaches only the patients for whom it is intended. They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely. "This is the approval of one specific CBD medication for a specific use", Gottlieb said. "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".