VANCOUVER, BC and CONSHOHOCKEN, PA, Nov. 20 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has completed enrollment in the pivotal Phase 3 chronic low back pain clinical trial of NMED-1077 (OROS(R) Hydromorphone) for the treatment of chronic moderate-to-severe pain in opioid tolerant patients.
"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," said Dr. Christopher Gallen, President and Chief Executive Officer. "If approved, this will be the only long-acting hydromorphone available in the U.S. market with a single dose providing around the clock pain relief for patients."
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 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(R) Hydromorphone in the U.S., Neuromed is conducting a second pivotal Phase 3 trial for the treatment of osteoarthritic pain. Patient enrollment for this second trial is ongoing.
The pivotal Phase 3 clinical trials of NMED-1077 are being studied under Special Protocol Assessment (SPA) agreements 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 a privately held biopharmaceutical company in business to develop new and improved pain medicines. Neuromed has three programs aimed at addressing this important unmet medical need. Its lead product, NMED-1077 (OROS(R) Hydromorphone), is an extended release formulation of hydromorphone in Phase 3 clinical development. Neuromed is also developing oral drug candidates to block N-type calcium channels, a new and important target directly involved in pain signaling. Its third program is focused on producing promising T-type calcium channel blockers aimed at treating pain, epilepsy and hypertension. For more information visit our website at www.neuromed.com.
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: regarding this press release, contact: Balraj Bains, Manager,
Communications, Neuromed Pharmaceuticals, Telephone: (604) 909-3371 or
(604) 909-2530, E-mail: firstname.lastname@example.org