Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of...( VANCOUVER BC and CONSHOHOCKEN PA Nov....),Health

VANCOUVER, BC and CONSHOHOCKEN, PA, Nov. 20 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has completed enrollment in the pivotal Phase 3 chronic low back pain clinical trial of NMED-1077 (OROS(R) Hydromorphone) for the treatment of chronic moderate-to-severe pain in opioid tolerant patients.

"The completion of patient enrollment brings us closer to reaching our goal of providing a highly effective once-daily pain medication for patients with chronic moderate-to-severe pain," said Dr. Christopher Gallen, President and Chief Executive Officer. "If approved, this will be the only long-acting hydromorphone available in the U.S. market with a single dose providing around the clock pain relief for patients."

The design of the Phase 3 trial of NMED-1077 is a randomized withdrawal, placebo-controlled, double-blind trial which is being conducted at multiple centers in the U.S. The study is evaluating the safety and efficacy of NMED-1077 in 269 opioid tolerant patients for the treatment of chronic low back pain. While the FDA indicated in an Approvable Letter that one successful adequate and well-controlled clinical trial will be needed to support approval of OROS(R) Hydromorphone in the U.S., Neuromed is conducting a second pivotal Phase 3 trial for the treatment of osteoarthritic pain. Patient enrollment for this second trial is ongoing.

The pivotal Phase 3 clinical trials of NMED-1077 are being studied under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). A SPA is a procedure by which sponsors and the FDA reach agreement on the design and size of clinical trials intended to form the primary basis to support approval of a New Drug Application.

About NMED-1077

Neuromed acquired from ALZA Corporation the U.S. marketing rights to NMED-1077, an extended release formula
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