Pharmaceutical firm Endo Intl (ENDP 11.82 -1.96) trades -14.22% lower today, erasing all of yesterday’s +11.8% affair following news that the US FDA has issued a request to ENDP to voluntarily withdraw its opioid pain medication, OPANA ER (oxymorphone hydrochloride), from the market.
First approved in 2006, recent postmarketing data on OPANA ER has revealed a significant shift in the route of abuse of OPANA ER from nasal to injection following the product's reformulation. The newer formulation was introduced in 2012, when ENDP replaced the original formulation of with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.
However, it became evident to the FDA that injection abuse of the reformulated OPANA ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). The FDA’s decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated OPANA ER no longer outweigh its risks.
ENDP commented that while the benefits of opioids in general in treating and managing pain are widely recognized, the misuse and abuse of said products have increased greatly in the U.S. Further, despite the FDA's request to withdraw OPANA ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. The company, as expected, 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.
All indications point to OPANA ER as a declining asset among ENDP’s pain management treatments. For instance, in Q4 (Feb 28), ENDP reported OPANA ER revenues had dipped 11% on a year-over-year basis to about $38.89 million. That being said, it’s not surprising that the ENDP is in retreat mode with a key, albeit declining, asset requested to be removed from shelves by the FDA.