Endo Pharmaceuticals had a not so good week this week. The FDA has asked the company to remove its opioid pain medication, Opana ER, from the market. The firm stated that the “benefits of the drug may no longer outweigh its risks.”
This is the very first time the FDA has asked a company to remove an opioid pain drug because of the public health consequences of abuse.
FDA Commissioner Scott Gottlieb said the firm “is looking broadly at the whole policy framework” used for the painkillers.
Despite Endo Pharmaceuticals reformulating the drug in 2012 so that it would be harder to snort, people are still injecting it and it has even led to a major HIV outbreak in 2015. There was also a hepatitis C outbreak in Indiana according to officials.
It was an 18-to-8 decision by the FDA advisory committee that led to requesting Endo take the drug off the market.
Janet Woodcok, the FDA’s Center for Drug Evaluation and Research Director said on Thursday, “The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.”
It has not been made clear if the company will remove the drug but the FDA has said that if Endo doesn’t, it would take steps to formally require its removal by withdrawing agency approval.
Endo said in a statement that the company is reviewing the FDA’s request but has defended the product and said it “remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
Disclaimer: We have no position in Endo Internat (NASDAQ: ENDP) and have not been compensated for this article.