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INSYS Therapeutics, Inc. Announces Positive Phase III Efficacy Trial Results for Fentanyl Sublingual Spray
Date:3/8/2010

PHOENIX, March 9 /PRNewswire/ -- INSYS Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain.  All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes (SPID(5)) in a phase III breakthrough cancer pain trial using Fentanyl.

The primary endpoint of the study was to measure the summary of pain intensity difference at thirty minutes (SPID (30)) compared to placebo.  INSYS' SL Spray significantly improved mean SPID (30) scores compared with placebo (p<0.0001).  The SL spray significantly improved mean SPID values compared with placebo as early as 5 minutes (p=0.022), while all other endpoints starting at ten minutes showed the p value remaining at or less than 0.0001.  Given breakthrough cancer pain's rapid onset and often peak intensity at three to five minutes, it is vital to provide patients with a faster onset of action.

Dr. Richard Rauck, a principal investigator in the Phase III study observed, "The sublingual spray demonstrated very rapid, effective pain relief. Patients began to experience meaningful pain relief within five minutes. This observation was supported by the clinical research findings.  To date, no other transmucosal Fentanyl product has produced pain relief this quickly. This early finding is supported with continued pain relief at all subsequent time intervals.  An easy-to-use oral spray that can produce effective, potent and very rapid pain relief will be a tremendous advantage for our patients who experience moderate to severe cancer breakthrough pain."

Michael Babich, President and COO of INSYS, adds, "We are delighted to announce today's results as it validates our thesis that a delivery system that can be administered in seconds will be a benefit to patients suffering from this indication.  More importantly, the results seen at five minutes will benefit patients and doctors who may struggle to find a product that can work quickly as breakthrough pain's onset is quite rapid.  In addition, many patients may not be able to take other currently available drugs due to difficulty in swallowing, nausea or other gastrointestinal problems.  Our device and array of strengths (100 to 1600 mcg) will allow patients to be treated at their appropriate titrated level.  Finally, we were excited to see that 97% of the patients randomized to the double blind period completed the study, while 92% rolled over to the safety portion."

Background on Breakthrough Cancer Pain and the Fentanyl SL Spray

Breakthrough cancer pain is a common, debilitating feature of chronic pain, seen in approximately 75% of patients with cancer. It is a severe pain flare-up that "breaks through" the relief provided by around-the-clock analgesics. Unlike persistent cancer pain, breakthrough cancer pain is generally rapid in onset and can last a couple hours with the average episode averaging thirty minutes. Patients with cancer may experience between two and seven episodes of breakthrough cancer pain a day.  It is estimated that over a half-million people in the U.S. with cancer suffer from breakthrough pain, however, only about 25,000 receive a treatment approved for the condition.

INSYS' Fentanyl SL spray provides quick administration of Fentanyl, a potential treatment for breakthrough cancer 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, Inc. 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.

SOURCE INSYS Therapeutics, Inc.

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