CONSHOHOCKEN, PA and VANCOUVER, BC, Nov. 1 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has dosed its first patient in its pivotal Phase 3 clinical trial of NMED-1077 (OROS(R) 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(R) PUSH-PULL(TM) osmotic delivery system to release hydromorphone at a controlled rate over an extended period. OROS(R) Hydromorphone has been approved in Germany and other European countries and is marketed by Janssen-Cilag under the name JURNISTA(TM).
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.
About Neuromed
Neuromed is a privately held biopharmaceutical company developing safer and more effective pain drugs. We are combining our pharmaceutical expertise in research, development and commercialization to improve existing pain treatments as well as develop new pain medicines. For more information visit www.neuromed.com.
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OROS(R) and PUSH-PULL(TM) are trademarks of ALZA Corporation.
Neuromed cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Neuromed's forward-looking statements due to the risks and uncertainties inherent in Neuromed's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Neuromed does not assume any obligation to update any forward-looking statements.
CONTACT: Julie Jang, Director, Communications, Neuromed Pharmaceuticals, Phone: (604) 909-2547, Email: jjang@neuromed.com
CONTACT: Julie Jang, Director, Communications, Neuromed Pharmaceuticals,
Phone: (604) 909-2547, Email: jjang@neuromed.com
