Thursday, pain drug maker Endo Pharmaceuticals (ENDP) revealed that the U.S. Food and Drug Administration has denied approval for the New Drug Application for its testosterone undecanoate injection Aveed for hypogonadism.
In its complete response letter to the New Drug Application, the FDA stated that the proposed Risk Evaluation and Mitigation Strategy for the drug is not sufficient. The company said the FDA has requested information to address the agency's concerns regarding serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.
Hypogonadism is a condition in men characterized by the body's failure to produce normal amounts of the hormone testosterone. An estimated four to five million men in the U.S. suffer from hypogonadism, of which only less than 10% are currently receiving treatment with testosterone therapy. Aveed is known as Nebido outside the U.S. and was expected to be the first three-month testosterone preparation available in the U.S.
Nebido was discovered and developed by Bayer Schering Pharma AG and was subsequently approved in 86 countries, including more than 50 countries across Europe, Asia Pacific, and Latin America. Endo Pharma acquired the license to Aveed from Bayer Schering through the acquisition of Indevus Pharmaceuticals, a company specializing in conditions in urology and endocrinology, earlier this year.
Chadds Ford, Pennsylvania-based Endo said it is currently evaluating the complete response letter and did not comment on future actions.
ENDP is losing $0.89 or 3.97%, and is trading at $21.53 on a volume of 2.70 million shares on the Nasdaq.
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