The Food and Drug Administration (FDA) has, for the third time, declined approval of the long-acting testosterone undecanoate injection product (Aveed, Endo Pharma Solutions) for the treatment of men with hypogonadism.
The US agency has issued a complete-response letter for the product, in which it stipulates that to support approval of a new drug application for Aveed, there would need to be updates to the risk evaluation and mitigation strategy (REMS), Endo Pharma Solutions said in a press release yesterday.
The decision comes as little surprise: last month, Aveed was discussed during a joint meeting of the FDA's Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee.
The vote on safety at that time was evenly split: 9 felt it was a safe therapy for testosterone replacement, while 9 said it was not. However, only 1 panel member felt the REMS put forth by the company was adequate.
Specifically, the FDA has now requested that the REMS include a medication guide as well as elements to ensure safe use to mitigate the risks and severe complications related to postinjection reactions, which are the US agency's major concern with regard to the product.
No Long-Acting Testosterone Products Available in United States
Testosterone undecanoate is a long-acting depot formulation of testosterone in castor oil and benzyl benzoate. The proposed indication is for adult men with conditions associated with a deficiency or absence of testosterone.
Testosterone undecanoate intramuscular injection has been approved for marketing in more than 90 countries. However, there are no long-acting forms of testosterone-replacement therapy currently available in the United States.
The FDA first denied approval of long-acting testosterone undecanoate in 2008, citing safety concerns, and then again in 2009 for safety concerns and questions about the risk/benefit profile.
The concerns stem largely from immediate postinjection reactions, some severe, that have been reported in clinical trials and postmarketing experience, primarily pulmonary oil microembolism and anaphylactic reactions. No deaths have been reported after postinjection reactions, but resuscitations and hospitalizations have been required in some cases.
Endo Pharma Solutions notes that yesterday's complete-response letter from the FDA does not include requests for the company to perform additional clinical studies.
"We appreciate the clarity around the path forward for Aveed," said Ivan Gergel, chief scientific officer of Endo Health Solutions. "We plan to submit a complete response by the end of the third quarter of 2013. We look forward to making this treatment option available to appropriate male patients in the US diagnosed with hypogonadism."
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Cite this: FDA Rejects Long-Acting Testosterone Injection for Third Time - Medscape - May 31, 2013.