FDA panel approves marijuana-based epilepsy drug

CBD Medication Gets Initial Acceptance From US Health Officials

UPDATE 1-FDA panel unanimously backs GW Pharma's cannabis-based epilepsy drug

If the FDA follows the group's recommendation, the syrup-based medicine would become the first drug derived from cannabis to win federal approval in the U.S. The FDA is expected to make its decision by late June.

The committee recommended that Epidiolex, an oral solution, be approved for treatment of severe, early-onset forms of epilepsy in a small number of patients.

More than two dozen states now allow the use of marijuana for the treatment of various conditions, but the FDA has never approved it for medical use.

If approved, Epidiolex (cannabidiol) would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs), GW noted.

In addition, GW has said FDA-approved CBD-based products would only be available at specialty or retail pharmacies, not dispensaries.

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"Clinically meaningful and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials in LGS and DS", the FDA report detailed.

CBD oil is now sold online and in small shops across the USA, but its legal status remains murky. Unlike medical marijuana, which contains a compound that can produce a high, cannabidiol isn't psychoactive.

GW Pharmaceuticals declined to comment on the price of the drug ahead of an approval decision. The FDA has approved synthetic versions of another cannabis ingredient for other medical purposes. "There are likely to be drug interactions, but that's not uncommon for antiepileptic medications".

During the panel meeting on Thursday morning, FDA regulators focused on whether Epidiolex causes enzyme elevations characteristic of liver toxicity - but ultimately deemed the management of these risks could be straightforward with proper communication and labeling. It's seeking approval for two rare forms of childhood epilepsy - Dravet and Lennox-Gastaut syndromes. More common side effects included diarrhea, vomiting, fatigue and sleep problems.

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