Insys Therapeutics, Inc. has submitted a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for its cannabidiol (CBD) active pharmaceutical ingredient (API) and has been issued DMF# 28255. Insys recently announced plans to advance development of its pharmaceutical CBD program for the treatment of epilepsy in children and adults.
"Advancing our pharmaceutical CBD programme is one of our top priorities and the DMF brings us another step closer to filing an Investigational New Drug Application (IND) for CBD in the second half of 2014," said Michael L. Babich, president and chief executive officer. "We are pleased to submit this voluntary filing, which enables us to comply with regulatory requirements and demonstrate the safety, efficacy and quality of our CBD program." A DMF is not a required regulatory filing and is submitted to the FDA at the discretion of the company. It contains factual and complete information on a drug product's chemistry, stability, purity profile, packaging, and manufacturing process.
During the first half of 2014, Insys announced plans to advance its pharmaceutical CBD programme for the treatment of epilepsy. In pediatrics, Insys plans to pursue development of treatments for Lennox-Gastaut Syndrome and Dravet Syndrome, which are orphan indications. Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: peripheral neuropathy in taxol-treated patients; addiction in cocaine, heroin and opioids; and glioblastoma.
"We believe that our company is uniquely positioned to provide commercial volumes of CBD for use in research and approval of CBD pharmaceuticals for an array of indications. This DMF moves us closer to the development of our own drugs, as well as encourages research and development using our compound for other therapies," Babich added.
The company has the capability to manufacture pharmaceutical CBD in its Round Rock, Texas facility. Insys believes that it is the only U.S. company with the capacity to produce pharmaceutical CBD in large quantities for commercial use of drug development.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative products for supportive care of cancer and pain patients.