Applications For Cannabis-Derived Products Up Sharply In Past 10 Years, FDA Says

WASHINGTON, D.C. – The Food and Drug Administration reports it is seeing a sharp rise in applications for products derived from cannabis, according to Forbes.

Since the early 1970’s, the FDA said it has received over 800 investigational new drug (IND) applications involving cannabis.  But about 400 of them were received in just the past 10 years, marking a 300 percent increase.

The data was contained in a paper written by Cassandra Taylor and Schuyler Pruyn of the Center for Drug Evaluation and Research.  The authors reported there has been increasing interest in the “evaluation of cannabis and cannabis-derived products (CCDPs) in human clinical trials”.

Among the applications, 53% were reported to be for research in the field of addiction and pain medicine, while 19% were for neurological conditions, 14% for immunology and inflammation and 9% for psychiatry.

Commercial drug developers and academic researchers submit applications to the FDA for INDs, which are required to conduct clinical trials in humans and transport a drug to trial sites.

To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. As of last year, the agency had approved one cannabis-derived drug product: Epidiolex (cannabidiol), and three synthetic cannabis-related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). These approved drug products are only available with a prescription from a licensed healthcare provider.

While the number of applications has been rising, the FDA said it also seeing increasingly varied methods for delivery of the cannabis used in clinical trials beyond cigarettes.  In the past decade, “the variety of product types being researched dramatically expanded to include an array of oral products, including baked goods, botanical extracts, capsules and tablets, oils, purified (or semi-purified) extracts, sweets (e.g., candies), tinctures, as well as vaporized products,” they said.

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