Debra Borchardt
Shares of GW Pharmaceuticals (GWPH) jumped on positive news in a Food & Drug Administration (FDA) report issued on Tuesday. The stock jumped 11% to trade at $134.14. The FDA briefing document said that GW’s drugs had positive results in treating patients with the rare Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS).
The report stated, “The applicant has provided positive results from three randomized, double-blind, placebo-controlled trials conducted in patients with LGS and DS. The design of the studies and primary endpoints are consistent with other studies that have been used to support drug approvals for epilepsy indications, including LGS. The studies are adequate and well-controlled. The statistically significant and clinically meaningful results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with LGS and DS.”
In addition to the comments of positive results, the briefing also noted the safety of the drug. It said, “The risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are debilitating, and life-threatening disorders.” The conclusion also stated that while the review is ongoing, the data in the application appears to support approval of cannabidiol for treatment of seizures associated with LGS and DS.
CBD is a cannabinoid that comes from the cannabis sativa plant and is structurally unrelated to other drugs approved for treatment of seizures. The controlled substances staff evaluated the abuse potential for CBD and concluded that CBD has negligible abuse potential. The staff found that CBD didn’t produce overt behaviors similar to those produced by drugs of abuse. The receptor sites associated with abuse potential like opioids, sedatives or hallucinogens had no significant affinity for CBD.
Another measure for drug abuse was whether the drug encourages self-administration. For example, cocaine has a high degree of self-administration, but CBD did not.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet Thursday, April 19 to review GW’s application for approval for its cannabidiol oral solution for patients that are at least two years old.
