Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on...( CONSHOHOCKEN PA and VANCOUVER BC ...),Health

CONSHOHOCKEN, PA and VANCOUVER, BC, Oct. 15 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has successfully reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the planned pivotal Phase 3 clinical trial of NMED-1077 (OROS(R) Hydromorphone) for the treatment of chronic pain. 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.

"The Special Protocol Assessment provides Neuromed with a clearly defined pathway for our Phase 3 trial to support regulatory approval of NMED-1077," said Dr. Christopher Gallen, Neuromed's President & CEO. "We believe a once-daily version of hydromorphone can be a significant benefit for patients with moderate to severe pain who require pain relief with opioids around the clock."

The Phase 3 trial of NMED-1077 is designed as a randomized withdrawal, placebo-controlled, double-blind trial which is being conducted at multiple centers in the U.S. The primary outcome measure is pain intensity at endpoint assessed by patients with an 11 point Likert Numerical Rating Scale (NRS). The study will target enrollment of 272 patients into the double-blind randomized withdrawal phase, and will evaluate the safety and efficacy of NMED-1077 in the treatment of chronic low back pain.

The FDA has completed its review of Neuromed's Investigational New Drug (IND) application for NMED-1077 and the IND is now open. Neuromed plans to begin enrollment in its first Phase 3 clinical trial of NMED-1077 later this year.

Neuromed acquired, from ALZA Corporation, the U.S. marketing rights to NMED-1077, an extended release formulation of hydromorphone. Hydromorphone is a Schedule II opioid that has been widely used for many years under the brand n
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