Endo Pharmaceuticals announced that the U.S. FDA has informed the company that FDA no longer sees a need to convene a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review Endo’s New Drug Application (NDA) for the new oral formulation of long-acting oxymorphone.
Dr. Ivan Gergel, Endo Pharmaceuticals’ executive vice president of research and development said, We remain committed to being a leader in the field of pain management and a partner to physicians to support the safe and appropriate use of opioids. FDA has informed us that it has gleaned sufficient information from previous advisory committee meetings to enable the division to reach a decision on our application without additional external expert input. We view this action as a positive step.
The new formulation of long-acting Oxymorphone designed to be crush-resistant, is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and was developed in partnership with Grunenthal GmbH. The action date set by FDA under the Prescription Drug User Fee Act (PDUFA) is Jan. 7, 2011.
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiary HealthTronics Inc., please visit www.endo.com.