New River presents study results for possible pain reliever, receives $50 million milestone

By Rebecca Melvin

Princeton, N.J., Feb. 7 - New River Pharmaceuticals Inc. presented phase 1/2 study results on a compound under development to treat moderate to severe pain, and announced that it had received a $50 million milestone payment from Shire plc, according to a company release.

The Radford, Va.-based biotechnology company's potential drug, NRP290, is intended to be a safer, abuse-resistance alternative to marketed opioids. It is a hydrocodone derivative under investigation as an alternative to Lortab, Vicodin and Vicoprofen.

The phase 1/2 study compared the bioavailability of two investigational formulations of NRP290 solution to Vicodin tablets in fasted-state healthy adults.

In the first comparison, the 90% confidence intervals for peak and overall exposure parameters of hydrocodone based on ln(Cmax), ln(AUClast) and ln(AUCinf) were within 80% to 125%.

In the second comparison, the 90% confidence intervals for peak of hydrocodone based on ln(Cmax) was within 80% to 125%. The upper limit of 90% confidence intervals for overall exposure parameters of hydrocodone based on ln(AUClast) and ln(AUCinf) were slightly higher (128.51% and 134.67%), according to the release.

While it is "difficult to recover or extract hydrolyzed hydocodone based on results to date," the company said that among its next steps in the second or third quarter is to request an end-of-phase 2 meeting with the Food and Drug Administration to finish efficacy and safety studies and define regulatory strategy.

Management also announced that the company had received a $50 million milestone payment from Shire plc, pursuant to a collaboration agreement for the development and commercialization of NRP104.

On Jan. 26, the FDA accepted for review New River's new drug application for NRP104, an investigational compound for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric populations, triggering the milestone payment.

New River presented its results at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference.

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