CONSHOHOCKEN, PA and VANCOUVER, BC, Oct. 15 /PRNewswire/ -Neuromed Pharmaceuticals, a biopharmaceutical company developing new andimproved chronic pain drugs, announced today it has successfully reached anagreement with the U.S. Food and Drug Administration (FDA) under the SpecialProtocol Assessment (SPA) process for the planned pivotal Phase 3 clinicaltrial 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 thedesign and size of clinical trials intended to form the primary basis tosupport approval of a New Drug Application.
"The Special Protocol Assessment provides Neuromed with a clearly definedpathway for our Phase 3 trial to support regulatory approval of NMED-1077,"said Dr. Christopher Gallen, Neuromed's President & CEO. "We believe aonce-daily version of hydromorphone can be a significant benefit for patientswith moderate to severe pain who require pain relief with opioids around theclock."
The Phase 3 trial of NMED-1077 is designed as a randomized withdrawal,placebo-controlled, double-blind trial which is being conducted at multiplecenters in the U.S. The primary outcome measure is pain intensity at endpointassessed by patients with an 11 point Likert Numerical Rating Scale (NRS). Thestudy will target enrollment of 272 patients into the double-blind randomizedwithdrawal phase, and will evaluate the safety and efficacy of NMED-1077 inthe 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 tobegin enrollment in its first Phase 3 clinical trial of NMED-1077 later thisyear.
Neuromed acquired, from ALZA Corporation, the U.S. marketing rights toNMED-1077, an extended release formulation of hydromorphone. Hydromorphone isa Schedule II opioid that has been widely used for many years under the brandname DILAUDID(R) and is also available from various generic manufacturers.Current formulations of hydromorphone marketed in the U.S. are immediaterelease, requiring dosing several times per day. NMED-1077 employs the OROS(R)PUSH-PULL(TM) osmotic delivery system to release hydromorphone at a controlledrate over an extended period. OROS(R) Hydromorphone has been approved inGermany and other European countries and is marketed by Janssen-Cilag underthe name JURNISTA(TM).
NMED-1077 is an investigational product and is not approved by the FDA foruse in the U.S. NMED-1077 has been studied in more than 1,000 patients inanalgesic trials. The most common adverse events seen in clinical trials todate are opioid-related events such as constipation, nausea, somnolence,headache, vomiting and dizziness. Respiratory depression is the most importanthazard of opioid preparations including NMED-1077.
Neuromed is also evaluating two pathways for the development of newclasses of oral pain drugs. In collaboration with Merck, Neuromed isresearching compounds designed to block the N-type calcium channel, a targetlinked to pain signal transmission. Separately, Neuromed is also developingT-type calcium channel blockers for the treatment of acute and chronic pain aswell as other potential disorders such as hypertension and epilepsy.
Neuromed is a privately held biopharmaceutical company in business todevelop safer and more effective pain drugs. We are combining ourpharmaceutical expertise in research, development and commercialization toimprove existing pain treatments as well as develop new pain medicines. Formore information visit www.neuromed.com.
Neuromed cautions you that statements included in this press release thatare not a description of historical facts may be forward-looking statements.Forward-looking statements are only predictions based upon currentexpectations and involve known and un