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INSYS Therapeutics Updates Timing Of NDA For Dronabinol Oral Solution


7/8/2014 6:55:41 AM

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PHOENIX, AZ--(Marketwired - July 08, 2014) - Insys Therapeutics, Inc. (NASDAQ: INSY), a specialty pharmaceutical company that is developing and commercializing innovative drugs and novel drug delivery systems, today announced the successful completion of a human abuse study for Dronabinol Oral Solution, its proprietary, orally administered liquid formulation of the synthetic cannabinoid dronabinol in development for the treatment of chemotherapy induced nausea and vomiting (CINV) and anorexia associated with weight loss in patients with AIDS.

Insys completed the clinical portion of the New Drug Application (NDA) for Dronabinol Oral Solution during the third quarter of 2013, as previously announced. The human abuse study was required by the U.S. Drug Enforcement Agency (DEA) for scheduling classification purposes. The Company now intends to file this NDA in the third quarter of 2014.

"We are very excited about Oral Dronabinol Solution, which is the culmination of significant research and which we believe has distinct advantages over the current formulation of dronabinol in a soft gelatin capsule, including more consistent bioavailability, faster onset of action and more flexible dose," said Michael L. Babich, President and Chief Executive Officer.

Dronabinol is currently available only in a soft gelatin capsule form. According to Symphony Health Solutions, total prescriptions of Dronabinol grew 5% in 2013 as compared to 2012. While the capsule is available in only three strengths (2.5mg, 5 mg and 10 mg), Insys' Dronabinol Oral Solution presents an opportunity for physicians to titrate more effectively.

"Even though the Dronabinol capsule product is off-patent and has no promotion behind it, the Symphony Health Solutions data indicates growth in prescriptions. We believe this growth is a result of heightened awareness of medical marijuana, which may not be tolerable by certain patients and for which Dronabinol capsules offer an alternative." Babich continued, "The many advantages of our Dronabinol Oral Solution should, assuming FDA approval, enable us to convert and expand this underserved market."

Insys is committed to Cannabinoid research and has an advanced manufacturing facility approved by FDA and DEA to produce pharmaceutical grade active pharmaceutical ingredient (API) Cannabinoids. Insys recently received Orphan Drug designation for its pharmaceutical Cannabidiol (CBD) candidate for Lennox-Gastaut Syndrome and Dravet Syndrome in pediatric populations, and is aggressively pursuing development of these indications.

About Insys Therapeutics, Inc.
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of 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 breakthrough 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 third quarter of 2014 and believes the oral solution formulation has distinct advantages over the current formulation of dronabinol in a soft gel capsule. The company is developing a pipeline of sublingual sprays, as well as pharmaceutical CBD. For more information please visit www.insysrx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding our expectations related to filing an NDA for an oral liquid formulation of Dronabinol in the third quarter of 2014; the potential approval and scheduling of oral liquid formulation of Dronabinol by DEA and FDA; the advantages of oral liquid formulation; our belief that we are uniquely positioned to penetrate and expand the existing market of the oral liquid formulation; our belief that we are the only U.S.-based company with the capacity to produce pharmaceutical cannabinoids in scalable quantities; and the development of our pipeline of sublingual sprays and pharmaceutical CBD. 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.




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