Endo International has announced that the US Food and Drug Administration's (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted 18 to eight, with one abstention, that the benefits of reformulated Opana ER (oxymorphone hydrochloride extended release) no longer outweigh its risks.
While several of the Advisory Committee members acknowledged the role of Opana ER in clinical practice, others believed its benefits are now overshadowed by the continuing public health concerns around the product's misuse, abuse and diversion. During the Advisory Committee discussion following the vote, a number of Committee members expressed their preference that Opana ER remain on the market with additional regulatory restrictions to mitigate the risks.
The FDA convened these Advisory Committees to discuss pre- and post-marketing data about the abuse of Opana ER, the product's overall risk-benefit profile, as well as the abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products. While the FDA will consider the Committees' vote, any decision regarding whether to take regulatory action rests solely with the Agency. Endo believes that Opana ER remains an important clinical choice for appropriate patients and will evaluate the range of available options for maintaining access for legitimate use.
"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," said Matthew W. Davis, M.D., R.Ph., senior vice president, research & development, branded pharmaceuticals at Endo. "Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options. 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."
Endo International is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and US headquarters in Malvern, PA.