On June 2, 2014 the FDA designated Insys Therapeutics’ (INSY) cannabidiol an Orphan Drug for the treatment of Lennox-Gastaut syndrome. (See FDA Site) The firm submitted its Type II Drug Master File to the FDA on May29. A copy of the Insys release on the filing is provided below.
Insys Therapeutics Submits Drug Master File for Cannabidiol Active Pharmaceutical Ingredient (API)
PHOENIX, AZ–( May 29, 2014) – Insys Therapeutics, Inc. (NASDAQ: INSY) today announced it has submitted a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for its cannabidiol (CBD) active pharmaceutical ingredient 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 program 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 program 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.
About Insys Therapeutics, Inc. Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative products for supportive care of cancer and pain patients. Using its proprietary sublingual spray technology and its capability to develop pharmaceutical cannabinoids, the company addresses the clinical shortcomings of existing commercial products. The company currently markets two products, Subsys, which is sublingual Fentanyl spray for break through cancer pain, and a generic version of Dronabinol (THC) capsules. The company plans to file a New Drug Application (NDA) for an oral liquid formulation of Dronabinol in the second half of 2014 and believes it is a clinically superior product to current Dronabinol capsules. The company is developing a robust pipeline of sublingual sprays, as well as pharmaceutical CBD.
Forward-Looking Statements This press release contains forward-looking statements, including statements regarding our expectations related to filing at least one Investigational New Drug application with the Food and Drug Administration in the second half of 2014 for pharmaceutical CBD, our plan to pursue the development of treatments for Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome related to epilepsy, the potential benefits of our pharmaceutical CBD therapies to patients and our intention to pursue orphan drug designation for all indications that qualify for orphan drug status. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. For a description of these risks facing the company, please see the risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2013 and any subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
Contact: Lisa M. Wilson In-Site Communications, Inc. Investor Relations 212-452-2793