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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

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. Patients were considered to be opioid tolerant if they were on chronic opioid therapy at a dose equivalent to (greater than or equal to) 60 mg/day of oral morphine for a period of time.

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(less than)0.0001) results in the protocol specified primary efficacy endpoint. In addition, results from statistical analyses of multiple secondary efficacy endpoints were consistent with the primary efficacy endpoint.

The overall safety profile and reported adverse events in the study were consistent with that of other strong opioids. The most commonly reported adverse events in the study were nausea, constipation, vomiting, arthralgia, insomnia and headache.

    (1) A SPA is a procedure by which sponsors and the FDA reach agreement on
        the protocol design, primary efficacy endpoints, and the data
        analysis of clinical trials needed to support approval of a New Drug
        Application (NDA).

About Exalgo

Neuromed acquired from ALZA Corporation the U.S. marketing rights to Exalgo, an extended release formulation of hydromorphone. Hydromorphone is a Schedule II opioid that has been used for many years. Oral hydromorphone products currently available in the U.S. are immediate release formulations, requiring dosing several times per day. Exalgo, if approved, will employ the OROS(R) PUSH-PULL(TM) osm
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SOURCE Neuromed Pharmaceuticals Ltd.
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