FDA committees find OPANA ER's risks outweigh benefits

Two U.S. Food and Drug Administration committees recently voted 18 to 8, with one abstention, that Endo International’s OPANA ER (oxymorphone hydrochloride extended release) no longer has a positive risk-to- benefits ratio.
"Endo remains confident that the body of evidence established through clinical research demonstrates that OPANA ER has a favorable risk-benefit profile when used as intended in appropriate patients," Dr. Matthew Davis, Endo's senior vice president, said. "Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options.”
The decision, from the Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory committees, comes amid increasing public health concerns over misuse, abuse and diversion of the drug. The FDA will take the committee’s votes into consideration as it determines whether or not to take regulatory action on the drug; after the vote multiple committee members expressed their belief that the drug should be kept on the market but more strictly regulated.
“We plan to work collaboratively with the FDA as the Agency completes its evaluation of OPANA ER, while advocating to preserve the important benefits of the medicine for patients," Davis said.