GW Pharmaceuticals continued its streak of good luck. The London-based drugmaker posted another set of positive phase 3 data for Epidiolex, an experimental cannabis drug being used to treat seizures in a rare form of epilepsy called Lennox-Gaustaut Syndrome (LGS).
Different doses yielded different results, according to GW’s announcement. A 20-mg dosage of the drug taken daily contributed to a 42 percent drop in monthly seizures compared to 17 percent for participants taking placebo. Volunteers taking 10mg a day experienced an estimated 37 percent monthly drop in seizures while the placebo portion of this group stayed at 17 percent.
Common adverse events varied between diarrhea and upper respiratory infections, but the pattern remained consistent with previous trials. Overall, the drug was generally well tolerated.
This new data bodes well for GW, reported Reuters.
A trove of positive data like this could help the 18-year-old firm support its case for regulatory approval potentially making Epidiolex the first U.S. approved prescription drug extracted from cannabis.
The U.S. Food and Drug Administration has already granted Epidiolex an orphan drug designation for LGS and a similar disorder called Dravet syndrome giving GW a formidable therapeutic candidate in a market that is just starting to develop.
A marketing application is expected to be submitted to the FDA in the first half of next year.
By Ryan Bushey - Drug Discovery & Development/Sept. 27, 2016
Dear Drugs-Forum readers: We are a small non-profit that runs one of the most read drug information & addiction help websites in the world. We serve over 4 million readers per month, and have costs like all popular websites: servers, hosting, licenses and software. To protect our independence we do not run ads. We take no government funds. We run on donations which average $25. If everyone reading this would donate $5 then this fund raiser would be done in an hour. If Drugs-Forum is useful to you, take one minute to keep it online another year by donating whatever you can today. Donations are currently not sufficient to pay our bills and keep the site up. Your help is most welcome. Thank you.
Epidiolex, GW Pharma's New Cannabis Drug for Rare Seizures, Set for Marketing Phase