Neuromed Pharmaceuticals announced positive results from a phase 3 clinical trial of its lead investigational drug, Exalgo (hydromorphone HCl) extended-release tablets, which was previously NMED-1077 and OROS(R) Hydromorphone.  Neuromed is seeking approval of Exalgo 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 pivotal phase 3 clinical trial of Exalgo was a double-blind, placebo-controlled study employing a randomized withdrawal design, conducted at 65 centers in the U.S. The study randomized 268 opioid tolerant patients with chronic moderate to severe low back pain for treatment of up to twelve weeks.  The primary efficacy endpoint was the mean change from baseline to week 12 (or last visit) of average weekly pain intensity scores compared to the placebo group, measured using an 11-point Likert Numerical Rating Scale (NRS) obtained from patient diaries. The study showed statistically significant (p<0.0001) results in the protocol specified primary efficacy endpoint.

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