FDA reviews NDA for Exalgo for chronic pain

Covidien, Neuromed Pharmaceuticals, and CombinatoRx announced that the FDA has heard presentations and public testimony and discussed the New Drug Application (NDA) submitted for Exalgo (hydromorphone HCl) extended release tablets for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Exalgo is an investigational opioid formulation that utilizes OROS Push-Pull (from ALZA Corporation), a unique, extended-release oral osmotic delivery system designed to release the hydromorphone at a consistent rate, thus allowing for once daily dosing.

For more information please call (484) 533-6900 or visit www.neuromed.com.