FDA approval

On June 25, GW Pharmaceuticals (GWPH) announced that it received FDA approval for Epidiolex (cannabidiol)—its oral solution. Epidiolex is a treatment option for patients two years and older who suffer from seizures due to Dravet Syndrome and Lennox-Gastaut Syndrome. These two syndromes are severe and rare forms of epilepsy. The syndromes are very difficult to treat. They’re characterized by developmental delays, varied types of seizures, and increased risk of the complication of sudden unexpected death in epilepsy. Epidiolex is the first FDA approved drug containing a marijuana derivative, CBD (cannabidiol).

GW Pharmaceuticals expects to launch Epidiolex in the United States within 90 days of securing FDA approval. Currently, CBD is classified as a Schedule I substance under the Controlled Substances Act. In June, GW Pharmaceuticals claimed that it expected the Drug Enforcement Administration to reclassify CBD within 90 days based on the FDA’s recommendations. GW Pharmaceuticals plans to ship Epidiolex from its inventory in the US distribution network after it reschedules CBD.

GWPH Prepares to Launch Epidiolex in the US MarketEpilepsy market opportunity

GW Pharmaceuticals has estimated the prevalence of epilepsy in the United States to be ~2.2 million—470,000 are children. Approximately 36% of the epilepsy patients are pharmacoresistant, which implies that they continue to suffer from seizures despite multiple medications.

Childhood-onset epilepsy is categorized into multiple orphan syndromes. Most of the syndromes don’t respond sufficiently to existing treatment options. Patients continue to suffer from seizures in adulthood. There aren’t any FDA approved therapies indicated for most of these specific syndromes.

Epilepsy syndromes like Dravet Syndrome and Lennox-Gastaut Syndrome are highly refractory to existing treatment regimens. The syndromes usually require patients to opt for polytherapy. Physicians haven’t been satisfied with existing treatment options. There’s definitely a significant unmet demand for Epidiolex.

Next, we’ll discuss GW Pharmaceuticals’ commercial initiatives to launch Epidiolex in the United States.

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