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news.Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, has completed enrollment in the pivotal Phase III chronic low back pain clinical trial of NMED-1077 for the treatment of chronic moderate-to-severe pain in opioid tolerant patients.
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The design of the Phase III trial of NMED-1077 is a randomized withdrawal, placebo-controlled, double-blind trial which is being conducted at multiple centers in the US. 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 Hydromorphone in the US, Neuromed is conducting a second pivotal Phase III trial for the treatment of osteoarthritic pain. Patient enrollment for this second trial is ongoing. The pivotal Phase III clinical trials of NMED-1077 are being studied under special protocol assessment agreements with the FDA.
Christopher Gallen, president and CEO, said: “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. If approved, this will be the only long-acting hydromorphone available in the US market with a single dose providing around the clock pain relief for patients.”