FDA Advisory Committees Find Benefits of Endo’s Opioid Drug Don’t Outweigh Risks

Advisory committees to the US Food and Drug Administration (FDA) have voted that the risk of abuse associated with Endo International’s opioid drug, Opana ER (oxymorphone hydrochloride extended release), outweighs its benefits. Members from the Drug Safety and Risk Management (DSaRM), and Anesthetic and Analgesic Drug Products (AADP) advisory committees, voted 18 to eight against the opioid drug.

The joint decision was made based on a number of factors, including the drug’s safety compared to other oxymorphone opioids, its risk-benefit profile, and the potential effect on patients if the drug were to be removed from the market. Despite one member of the committees abstaining from the vote, the majority of voters found that the benefits of Opana ER did not outweigh the risks.

According to the National Institute on Drug Abuse, 2.1 million people in the US suffered from prescription opioid abuse in 2012. The Centers for Disease Control and Prevention (CDC), reported that over 50 percent of 33,000 deaths attributed to opioid overdoses in 2015, were caused by abuse of prescription opioids.

In light of this opioid crisis, governments and regulators are cracking down on opioid drugs in an attempt to control the issue. Much of the blame has fallen upon drugmakers and distributers who supply opioid medications to hospitals, pharmacies and patients.

The FDA often follows the advice of these advisory committees, however they are not bound by law to do so. The FDA could decide to impart additional regulatory restrictions on the use of Opana ER, with the possibility that the opioid drug could be removed from the market altogether.

Currently, Opana ER is Endo’s highest-grossing pain management drug; in 2016, the drug brought in nearly $16 million in sales. For its part, Endo is committed to reduce abuse of the opioid medication by funding initiatives and implementing a pharmaceutical sterilization plan to reduce counterfeiting of the drug.

“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 Dr. Matthew W. Davis, 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.”