FDA Gives Fast Track Status to GW Pharma’s Cannabinoid Treatment
June 6th, 2014
Policy, Top News
The U.S. Food and Drug Administration (“FDA”) hasn’t exactly won widespread praise among the investment community. Clinical trials are notorious for eating up millions of dollars and taking many years to complete, thereby raising the costs associated with pharmaceuticals and medical devices. But, the administration’s approach to cannabis may finally be taking a turn for the better.
Despite being classified as a Schedule I Controlled Substance federally, the FDA permitted GW Pharmaceuticals plc [stockquote symbol=”GWPH”] to conduct clinical trials demonstrating the efficacy of cannabinoids to treat a rare form of epilepsy. The company’s Epidiolex is designed to suppress seizures in patients with Dravet syndrome, a treatment-resistant form of childhood epilepsy.
The FDA announced this week that it would grant the drug Fast-Track status to accelerate its time to market. By targeting rare untreatable diseases, companies can access the FDA’s fast-track program designed to get important drugs to patients earlier than a traditional review process. The designation provides early and frequent communication with the FDA throughout the entire process.
While the news is certainly great for GW Pharmaceuticals plc, it’s also positive for other companies in the medical cannabis sector pursuing similar programs. The FDA’s support for cannabis comes after significant criticism from lawmakers and a stigma attached to the drug in the public’s eyes for many years. Recently, data has shown that cannabinoids may be very effective, however, in treating diseases.
In addition to epilepsy, many companies are pursuing cannabinoid treatments for conditions like pain management, cancer therapeutics, and neurological conditions like Alzheimer’s disease. The FDA’s fast-track designation for childhood epilepsy could also expedite other diseases that don’t have any existing treatments for which cannabinoids could prove highly efficacious and safe.
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
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