- Two Food and Drug Administration advisory committees on Tuesday determined that one of Endo Pharmaceuticals' marketed opioid drugs carries too high a risk of abuse despite its potential health benefits.
- The joint panel, comprised of 27 voting members from the Drug Safety and Risk Management (DSaRM) and Anesthetic and Analgesic Drug Products (AADP) advisory committees, evaluated Opana ER's (oxymorphone hydrochloride extended release) safety compared to other oxymorphone products, its risk-benefit profile, and possible consequences to patients if the FDA imposed regulatory action on the drug.
- In an 18 to eight vote, the joint panel concluded the benefits of Opana ER did not outweigh the risks. One member abstained from voting. The decision comes as the U.S. grapples with a nationwide opioid abuse epidemic. As of 2012, an estimated 2.1 million people in the country suffer from disorders related to prescription opioids, according to the National Institute on Drug Abuse.
Opioid overdoses led to more than 33,000 deaths in the U.S. in 2015, or about 90 deaths per day. Roughly half of those overdoses came from prescription opioids, according to the Centers for Disease Control.
With such alarming figures, patients, advocacy groups and lawmakers have placed much of the blame of medicine developers and distributors and their roll in keeping the prescription opioid supply flowing.
In March alone, two West Virginia counties and a city in Washington state have launched lawsuits against companies including Amerisource Bergen, Cardinal Health, CVS Health Corp., McKesson Corp., Purdue Pharma and Walgreens Boots. New York City Mayor Bill de Blasio lambasted the pharmaceutical industry's role in the epidemic earlier this week, and announced a plan to funnel $38 million a year to help address opioid addiction and other health concerns.
While the FDA is not bound to the advisory committees' vote, it usually follows such advice. Assuming the agency heeds the vote, it could seek a number of reforms for Opana ER, with the most severe being the drug's removal from market. That would be a big loss for Endo, as Opana ER is the company's most profitable pain management drug. The treatment raked in almost $160 million in 2016, more than 10% of the company's U.S. branded pharmaceuticals revenue, according to Endo's annual financial filings.
"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," Matthew Davis, head of branded pharmaceuticals R&D for Endo, said in a March 14 statement.