Neuromed's pivotal Ph III NMED-1077 trial completes enrollment

Neuromed Pharmaceuticals, a US biopharmaceutical company, has completed enrollment in the pivotal Phase III chronic low-back pain trial of NMED-1077 (hydromorphone extended-release) for long-term, moderate-to-severe pain in opioid-tolerant patients.

Company chief executive Christopher Gallen said that, if approved, this will be the only long-acting hydromorphone available in the US market with a single dose providing round-the-clock pain relief. The agent employs the OROS PUSH-PULL osmotic delivery system to release the schedule II opioid at a controlled rate over an extended period. It has been approved in Germany and other European countries, where it is sold by Janssen-Cilag as Jurnista.

The randomized-withdrawal, placebo-controlled, double-blind trial is being conducted at multiple centers in the USA, involving 269 patients. 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 Hydromorphone in the USA, Neuromed is conducting a second pivotal Phase III study for osteoarthritic pain. Patient enrollment for this second trial is ongoing. The firm licensed the product from fellow USA-based ALZA, a unit of health care major Johnson & Johnson, in a deal involving an upfront payment of $30.0 million (Marketletter May 7).