New River Pharmaceuticals Inc. Conducts End-Of-Phase II Meeting With FDA For NRP290

New River Pharmaceuticals Inc. announced that company officials conducted an end- of-phase II meeting on Thursday with staff members of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration to discuss NRP290, under development as a potential treatment for acute pain. A derivative of hydrocodone, NRP290 has undergone two pharmacokinetic clinical studies.

RJ Kirk, New River's chairman and CEO, commented, "This is certainly an exciting time for New River. This week's discussions with the FDA will help us finalize our efficacy and safety studies and define our regulatory strategy as we advance NRP290 into late-stage testing."

We believe our proprietary Carrierwave™ technology can be applied in various ways to improve existing drugs. We refer to our Carrierwave™ compounds as Conditionally Bioreversible Derivatives (CBDs). We create a new molecule—a derivative—made of the active pharmaceutical ingredient of a drug such as an amphetamine or opioid, covalently attached to an adjuvant. We design the new molecules to be pharmacologically inactive and only activated ("bioreversed") when taken as directed.

Their lead compounds in amphetamines and opioids are designed to confer overdose protection by restricting the release of the active pharmaceutical ingredient from the CBD at greater than therapeutically prescribed amounts. The CBDs are also designed to be less prone to abuse and addiction by limiting the "rush" or "high" available from the active pharmaceutical ingredient released by the CBD and limiting the ability of abusers to obtain greater doses of the active ingredient through alternative routes of administration or extraction techniques. As a result of these characteristics, we believe that some of our CBDs may be subject to fewer restrictions by the DEA on their manufacture, distribution, prescribing and dispensing.

Extended release opioids will be a great help to people with chronic pain.
NRPH closed down friday at 45.82 or 29 cents per share.