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Neuromed Announces Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial
Date:3/23/2009

CONSHOHOCKEN, PA and VANCOUVER, BC, March 23 /PRNewswire/ - Neuromed Pharmaceuticals, Inc. today announced positive results of a pivotal phase 3 clinical trial of its lead investigational drug, Exalgo (hydromorphone HCl) Extended-Release Tablets (CII) (previously NMED-1077 and OROS(R) Hydromorphone). The trial met its primary efficacy endpoint, the mean change from baseline to week 12 (or last visit) of average weekly pain intensity scores, and the results were statistically significant (p(less than)0.0001). The primary efficacy endpoint was agreed upon with the U.S. Food and Drug Administration (FDA) during the Special Protocol Assessment (SPA) process(1).

Neuromed is seeking approval of Exalgo in the U.S. for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The FDA has stated in an Approvable Letter that one successful adequate and well-controlled clinical trial will be needed to support approval of Exalgo.

"The successful completion of our pivotal phase 3 clinical trial brings us closer to reaching our goal of providing an effective once-daily pain medication for opioid tolerant patients with moderate to severe pain requiring around-the-clock opioid analgesia for an extended period of time," said Dr. Christopher Gallen, President and Chief Executive Officer of Neuromed. "We have now successfully completed a major milestone of our development plan and are on schedule to submit our FDA application planned for the second quarter of 2009."

Martin E. Hale, M.D., Principal Investigator of the pivotal phase 3 clinical trial stated, "Hydromorphone is a clinically proven analgesic that is not currently available in a long acting oral formulation. Exalgo, if approved, will provide an additional option in the treatment of chronic moderate to severe pain in opioid tolerant patients."

Study Design and Results


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SOURCE Neuromed Pharmaceuticals Ltd.
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