GW Pharmaceuticals CEO Justin Gover said that with the ‘final step’ in the regulatory process completed, the company was working hard on a quick roll-out
GW Pharmaceutical 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).
The UK-based, US-listed company has developed treatments for Dravet and Lennox-Gastaut syndromes – two rare types of childhood epilepsy that are highly treatment-resistant.
Epidiolex, which was approved by the US Food and Drug Administration (FDA) in June 2018 for the treatment of seizures associated with Lennox-Gastaut and Dravet syndromes 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.
“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,” GW Pharmaceuticals CEO Justin Gover said in a statement.
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.
Medicines in Schedule V have a proven medical use and low potential for abuse. It is worth noting that other non-FDA-approved CBD preparations still remain in Schedule I so Epidiolex is a path breaker. Some examples of Schedule V drugs are cough preparations such as Robitussin AC, and a number of commonly prescribed anti-epilepsy drugs such as VIMPAT, BRIVIACT, and Lyrica.
Cantor Fitzgerald reiterates $211 price target
According to TheFly.com, analysts at Cantor Fitzgerald described the Epidiolex DEA rescheduling as the ‘best possible outcome’ for GW Pharmaceuticals. Analyst Elemer Piros reiterated an Overweight rating and $211 price target on GW Pharmaceuticals stock.