Aveed Faces Fresh Obstacle on Road to FDA Approval

Endo Pharmaceuticals has once again been denied approval by the Food and Drug Administration, or FDA, for Aveed, their long-acting testosterone undecanoate injection. The drug is designed to treat men with hypergonadism, a condition where the function of the testes is diminished and men do not produce enough testosterone.

This is the latest obstacle that the drug has faced since Endo Pharmaceuticals submitted a new drug application in August 2007. The FDA was concerned about post-injection reactions and denied the application in June 2008. In March 2009, Endo Pharmaceuticals sent additional safety data to the FDA in support of their application, but this failed to change the FDA’s position. The agency remained concerned about the risks of the drug, and in December of that year sent Endo a complete response letter (CRL).

The latest development is another CRL, this time after a vote was taken by two FDA committees. In April the FDAs Reproductive Health Drugs Advisory Committee met alongside their Drug Safety and Risk Management Advisory Committee to decide if Aveed was safe to treat men with low levels of testosterone. The outcome was a 9-9 tie as the issue of post-injection reactions came up again. Castor oil is used in the drug’s formulation, and the panel was concerned that this could cause a pulmonary oil micro embolism, which is a blood clot on the lungs. There were also questions about the use of benzyl benzoate as an ingredient as it has been known to cause anaphylaxis, a severe and potentially lethal allergic reaction.

In the latest CRL, the FDA outlined the steps needed before the agency could support a new drug application for Aveed. They did not ask Endo to conduct any further clinical studies, but they did request a revised Risk Evaluation Mitigation Strategy (REMS). Two components that they asked to see in the REMS are Elements to Assure Safe Use and a Medication Guide.

Ivan Gurgel, the chief scientific officer and executive vice president of research and development at Endo Health Solutions, saw the latest complete response letter as a positive step. In a statement, he said that the company was “encouraged” by the FDA feedback and appreciated the “clarity around the path forward.” He went on to add that the company planned to send a complete response to the FDA by the third quarter of 2013.

Related Reading:
Regulatory update May 30 http://www.drugs.com/nda/aveed_130531.html
FDA Advisory Committee notice http://www.fda.gov/AdvisoryCommittees/Calendar/ucm343879.htm
Pharma Times article http://www.pharmatimes.com/article/13-05-31/FDA_refuses_approval_for_Endo_s_Aveed_again.aspx