GW Pharmaceuticals’ Epidiolex cannabis drug for epilepsy to be available within six weeks as DEA lowers restriction
GW Pharmaceuticals Plc (Nasdaq:GWPH), a biotech focused on developing novel therapeutics from its proprietary cannabinoid (CBD) product platform, along with its US subsidiary Greenwich Biosciences, announced Thursday that its Epidiolex cannabis-based oral solution-based drug for epilepsy has been transferred to Schedule V, the lowest restriction classification, by the US Drug Enforcement Administration (DEA).
Epidiolex, which was approved by the US Food and Drug Administration (FDA) in June 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.
The pharma company’s stock jumped nearly 8% to $176.11 on Nasdaq.
READ: GW Pharma to present more data on cannabidiol-based epilepsy drug this week
“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,” said GW Pharmaceuticals CEO Justin Gover.
The drug company CEO said that with the final step in the regulatory process completed, the company was working hard to make Epidiolex available within the next six weeks.
“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,” said Grover.
Contact Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/205894/gw-pharmaceuticals-epidiolex-cannabis-drug-for-epilepsy-to-be-available-within-six-weeks-as-dea-lowers-restriction-205894.html
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