Endo Pharmaceuticals (ENDP) hit a roadblock related to the approval of Aveed. Recently, the company received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its injectable testosterone product Aveed for men diagnosed with low testosterone, also known as hypogonadism.

The FDA is concerned about the adverse events including post-injection anaphylactic reaction and pulmonary oil microembolism. In the CRL, the company has been asked to address these concerns. Additionally, the FDA has made it clear that it is not satisfied with the proposed Risk Evaluation and Mitigation Strategy (REMS) adopted by the company.

Aveed, known as Nebido outside the US, has been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America. The drug is sold outside the US by Germany’s Bayer AG (BAYRY). Endo licenses Aveed from Bayer.

For the past few months, Endo has been trying to build up its urology and endocrinology portfolio. In fact, Aveed was added to the company’s portfolio with the acquisition of Indevus Pharmaceuticals earlier this year. Thereafter, in August 2009, the company signed another agreement with UK-based ProStrakan Group Plc to acquire exclusive rights to commercialize Fortesta in the US, where the product is currently under FDA review. Fortesta is a 2% testosterone transdermal gel for testosterone replacement therapy in male hypogonadism. The drug is already available in Europe.

Hypogonadism is a common yet largely under-recognized and under-treated condition. It is estimated that about 13.8 million American men have testosterone levels that are below normal. However, only about 9% of these men are treated with testosterone replacement therapy.

Once launched, Fortesta and Aveed will compete with Auxilium Pharma’s (AUXL) Testim and Solvay Pharmaceuticals’ AndroGel.

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