GW Pharmaceuticals PLC (NASDAQ: GWPH) shares made a solid gain on Thursday after it received a critical update from the U.S. Drug Enforcement Administration (DEA).
Essentially, the agency transferred Epidiolex (cannabidiol) to Schedule V, its lowest restriction classification.
Epidiolex, which was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.
This was the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.
Medicines in Schedule V have a proven medical use and low potential for abuse. DEA’s decision to move Epidiolex to Schedule V was based on non-clinical and clinical data that evaluated the medicine’s potential for abuse and applies only to CBD products approved by the FDA.
Justin Gover, GW’s CEO, commented:
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.
Shares of GW Pharma were last seen up about 6% at $173.83, with a consensus analyst price target of $172.11 and a 52-week trading range of $96.42 to $179.65.