Endo Health Solutions ($ENDP) has lost its latest bid to gain FDA approval of a long-acting testosterone injection called Aveed, which Reuters notes has failed to gain a market green light from the U.S. agency at least two previous times.
The complete response marks the latest setback for Malvern, PA-based Endo. Earlier this month the FDA denied the company's citizen petition to block the sale of generic versions of its Opana ER pain medication and balked on the company's request for a label update that highlighted the abuse-prevention properties of Opana ER, which faces competition from copycat versions.
There's more: On the eve of announcing the latest setback for Aveed, Endo disclosed that two top executives, CFO Alan Levin and COO Julie McHugh, were leaving the company. McHugh, who is leaving immediately, won't stick around for the company's next attempt to gain approval for the drug against hypogonadism, a condition characterized by lack of sex hormone production.
In the FDA's complete response letter, the agency harped on the insufficient REMS plan from Endo and advised that the company add a medication guide and other elements to cut the risk of severe adverse reactions to the injected therapy, according to the company's release. Yet the company saw no mention of additional clinical study requirements, and Endo's chief scientist Ivan Gergel said the company plans to respond to the agency's requests by the end of the third quarter.
As Reuters noted, FDA advisers last month shot down Endo's plan to reduce risks of taking Aveed. The treatment combines testosterone and castor oil. The FDA has raised concerns about the oil triggering blockages to blood vessels in the lungs.
- here's the company's release
- see Reuters' article