GW Pharmaceuticals PLC (NASDAQ: GWPH)
The U.S. Drug Enforcement Agency has transferred a cannabis-based drug manufactured by GW Pharmaceuticals PLC to the lowest restriction classification, according to a statement released by the company on Thursday.
The drug, known as Epidiolex, is now classified as a Schedule V substance. The agency approved Epidiolex four months ago for treating Dravet and Lennox-Gastaut syndromes in patients aged 2 years or older.
Epidiolex is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol. Unlike marijuana and other schedule I substances, this new antiepileptic drug does not make people high.
The drug will be available in the market within the next six weeks. Other similar cannabidiol products are still awaiting regulatory approval for a Schedule I status.
Shares of the company rallied more than 10% to hit a record high of $179.65. The number of shares traded reached 1.9 million in the afternoon session, roughly four-times the full-day average.
GW Pharmaceuticals CEO Comments
“We are pleased that the DEA has placed EPIDIOLEX in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians. With this final step in the regulatory process completed, we are working hard to make EPIDIOLEX available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” stated Justin Gover, Chief Executive Officer of the company.
GW Pharmaceuticals PLC Profile
GW Pharmaceuticals plc, a biopharmaceutical company, engages in discovering, developing, and commercializing cannabinoid prescription medicines using botanical extracts derived from the Cannabis plant. The company operates through three segments: Commercial, Sativex Research and Development, and Pipeline Research and Development.
Its lead product is Epidiolex, an oral medicine which is in Phase III clinical development for the treatment of refractory childhood epilepsies, as well as for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms. The company also develops and markets Sativex, an oromucosal spray for the treatment of spasticity due to multiple sclerosis.
In addition, it develops various product candidates, which are in Phase I and II clinical development for the treatment of glioma, neonatal hypoxic-ischemic encephalopathy, adult epilepsy, and schizophrenia. Further, the company has license and development agreements with Otsuka Pharmaceutical Co. Ltd.; Almirall S.A.; Bayer HealthCare AG; Ipsen Biopharm Ltd; and Neopharm Group.
It primarily operates in Europe, the United States, Canada, and Asia. GW Pharmaceuticals plc was founded in 1998 and is based in Cambridge, the United Kingdom. – Yahoo Finance
