INSYS Therapeutics, Inc. Announces Completion of Efficacy Trial for Fentanyl Sublingual Spray

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Jan 25, 2010, 04:01 ET

PHOENIX, Jan. 25 /PRNewswire/ -- INSYS Therapeutics, Inc. announced today the successful completion of the Phase III efficacy clinical trial for its fentanyl sublingual spray product candidate. The product is being developed for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant cancer patients and the Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study. Dose levels of 100 – 1600 mcg were tested in the trial. In the double-blind portion of the trial, patients treated ten episodes of breakthrough cancer pain. The primary efficacy endpoint is Summed Pain Intensity Differences at 30 minutes after dosing (SPID30).

Dr. Richard Rauck, a principal investigator in the Phase III study observed: "Cancer patients suffering significant breakthrough pain found the sublingual (under the tongue) spray of fentanyl produces very fast, effective, and reproducible pain relief. Patients tolerated the spray very well and were extremely pleased with its overall pain-relieving effect and general lack of side effects."

Of the 97 patients that completed the trial, 93% elected to continue treatment in the extension study. Dr. Janet Bull, Chief Medical Officer at Four Seasons in Flat Rock, N.C. adds: "I feel our patients with breakthrough cancer pain have experienced faster onset of pain relief and improved quality of life from this medication. This new delivery system of an oral spray has the potential to offer quick relief for patients suffering from cancer pain."

About Fentanyl Sublingual Spray

INSYS' sublingual spray provides quick administration of fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). The single unit dose device is formulated with the opioid narcotic fentanyl for delivery to the oral mucosa. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain.

About INSYS Therapeutics, Inc.

INSYS Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative products that address chemotherapy-induced nausea and vomiting (CINV), pain management and other central nervous system disorders. We develop new formulations and delivery methods for existing drugs in order to achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery and increased patient compliance. Our drug development programs are based on existing compounds with known or proven safety, efficacy and commercialization histories. We are focused on leveraging our expertise in the expanding synthetic cannabinoid derivatives and specialized opioid markets to build a portfolio of proprietary products that address the limitations of existing therapies.