Neuromed Initiates Pivotal Clinical Trial For Chronic Pain
Neuromed Pharmaceuticals has dosed its first patient in its pivotal Phase 3 clinical trial of NMED-1077 (OROS Hydromorphone) for the treatment of chronic moderate-to-severe pain.
"The options for strong once-daily pain relief medications in the U.S. for patients with chronic moderate-to-severe pain are limited and we believe NMED-1077 has the potential to address this unmet medical need," said Dr. Christopher Gallen, Neuromed's President & CEO. "The commencement of our pivotal Phase 3 trial of NMED-1077 is a significant milestone for Neuromed."
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 will target enrollment of 272 patients and will evaluate the safety and efficacy of NMED-1077 in the treatment of chronic low back pain.
The pivotal Phase 3 clinical trial of NMED-1077 is being studied under an approved Special Protocol Assessment (SPA) agreement 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.
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. Current formulations of hydromorphone marketed in the U.S. are immediate release, requiring dosing several times per day. NMED-1077 employs the OROS PUSH-PULL osmotic delivery system to release hydromorphone at a controlled rate over an extended period. OROS Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA.
NMED-1077 is an investigational product and is not approved by the FDA for use in the U.S. NMED-1077 has been studied in more than 1,000 patients in analgesic trials. The most common adverse events seen in clinical trials to date are opioid-related events such as constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including NMED-1077.
Neuromed is also evaluating two pathways for the development of new classes of oral pain drugs. In collaboration with Merck, Neuromed is researching compounds designed to block the N-type calcium channel, a target linked to pain signal transmission. Separately, Neuromed is also developing T-type calcium channel blockers aimed at treating acute and chronic pain as well as hypertension and epilepsy.