FDA News

FDA panel rules Opana ER’s risks outweigh benefits

An FDA advisory committee recently voted 18-8, with one abstention, that the benefits of the opioid Opana are not as substantial as the risks, according to an agency spokesperson.

The drug’s manufacturer continues to assure that Opana (oxymorphone hydrochloride extended release, Endo Pharmaceuticals) can be helpful for pain management.

"[We] remain 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," Matthew W. Davis, MD, RPh, senior vice president, research and development, Endo Pharmaceuticals, said in a press release. “Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options.”

The FDA stated that members of the FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committee discussed reports of a thrombotic thrombocytopenic purpura-like illness and HIV transmission connected to IV abuse of the drug before taking its vote.

According to the Endo release, some of the committee members expressed a desire for Opana to stay on the market with “additional regulatory restrictions to mitigate the risks” of the drug.

Moving forward, the FDA will assess potential next steps including safety labeling changes, modifying the Risk Evaluation and Mitigation Strategies program and/or removing Opana from the market for safety reasons. As of press time, an FDA spokesperson told Healio Family Medicine there are no meetings or votes on this scheduled.

Endo stated that it will work with the FDA as it completes its evaluation.

The United States’ is currently experiencing an “opioid epidemic,” with multiple data sources suggesting ED visits, inpatient stays and other medical emergencies connected to opioid use continue to rise. Taking steps to curb opioid abuse has been a focus over the last several months for the FDA, which has approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.

Further reading : http://www.endo.com/news-events/press-releases

Disclosure: Healio Family Medicine was unable to confirm relevant financial disclosures prior to publication.

An FDA advisory committee recently voted 18-8, with one abstention, that the benefits of the opioid Opana are not as substantial as the risks, according to an agency spokesperson.

The drug’s manufacturer continues to assure that Opana (oxymorphone hydrochloride extended release, Endo Pharmaceuticals) can be helpful for pain management.

"[We] remain 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," Matthew W. Davis, MD, RPh, senior vice president, research and development, Endo Pharmaceuticals, said in a press release. “Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options.”

The FDA stated that members of the FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committee discussed reports of a thrombotic thrombocytopenic purpura-like illness and HIV transmission connected to IV abuse of the drug before taking its vote.

According to the Endo release, some of the committee members expressed a desire for Opana to stay on the market with “additional regulatory restrictions to mitigate the risks” of the drug.

Moving forward, the FDA will assess potential next steps including safety labeling changes, modifying the Risk Evaluation and Mitigation Strategies program and/or removing Opana from the market for safety reasons. As of press time, an FDA spokesperson told Healio Family Medicine there are no meetings or votes on this scheduled.

Endo stated that it will work with the FDA as it completes its evaluation.

The United States’ is currently experiencing an “opioid epidemic,” with multiple data sources suggesting ED visits, inpatient stays and other medical emergencies connected to opioid use continue to rise. Taking steps to curb opioid abuse has been a focus over the last several months for the FDA, which has approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.

Further reading : http://www.endo.com/news-events/press-releases

Disclosure: Healio Family Medicine was unable to confirm relevant financial disclosures prior to publication.