- In an unprecedented, but not unexpected action, the FDA has notified Endo International's (NASDAQ:ENDP) Pharmaceuticals unit that it wants opioid pain med OPANA ER (oxymorphone HCl) removed from the market due to its abuse potential.
- The medication was first approved in 2006 and was replaced by an abuse-deterrent formulation 2012 designed to make the drug resistant to physical and chemical manipulation. The new version met the regulatory standards for approval, but the data failed to show that the reformulation would reduce abuse/misuse to a meaningful degree.
- The agency has asked the company to voluntarily withdraw the product from the market. If it balks at doing so, the regulator will withdraw approval.
- In March, a joint meeting of FDA advisory committees voted 18 - 8 that the benefits of OPANA ER no longer outweigh the risks.
- OPANA ER generated sales of $35.7M in Q1, representing 3.4% of the company's total revenues and 4.9% of U.S. Generic Pharma sales.
- Shares are down 14% after hours on robust volume.
- Insys Therapeutics (NASDAQ:INSY) is down 4% in sympathy.
- Previously: Endo International gets Ad Comm thumbs down on opioid OPANA ER (March 15)
- Now read: Earnings Preview: Valeant Pharmaceuticals (NYSE:VRX)
Original article