Navigation Links
Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of NMED-1077

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.

About NMED-1077

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.

About Neuromed

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

    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.

SOURCE Neuromed Pharmaceuticals Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Nfocus Neuromedical Announces Acquisition of StarFire Medical
2. Nfocus Neuromedical Receives CE Mark for the CardioVasc(TM) Stent-Graft and Delivery System
3. Neuromed Appoints Jeffrey Arcara and Gene Wright to Senior Management Team
4. Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077
5. Ashland Completes Acquisition of Hercules
6. Conseco Completes Transfer of Senior Health Insurance Company of Pennsylvania to Independent Trust
7. Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders
8. Cardium Completes $6.0 Million Financing
9. PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eFlow for CF
10. TomoTherapy Completes Acquisition of Linear Accelerator Manufacturer in China
11. Phyhealth Completes $250,000 Funding
Post Your Comments:
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... ... 24, 2016 , ... Those who have experienced traumatic events may suffer from ... avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid this ... coping following a traumatic event. , Trauma sufferers tend to feel a range of ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its first-ever ... Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding work ... Practice and Pediatric Emergency Medicine Practice. , “With this award, we recognize ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... 2016 Capricor Therapeutics, Inc. ... biotechnology company focused on the discovery, development and ... enrollment in its ongoing randomized HOPE-Duchenne clinical trial ... of its 24-patient target. Capricor expects the trial ... of 2016, and to report top line data ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
Breaking Medicine Technology: