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

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."


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SOURCE INSYS Therapeutics, Inc.
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