FDA accepts Indevus IND for Nebido for male hypogonadism

By Lisa Kerner

Erie, Pa., March 9 - Indevus Pharmaceuticals, Inc. said the Food and Drug Administration has accepted its Investigational New Drug application for Nebido, a long-acting injectable testosterone preparation for the treatment of male hypogonadism.

The company plans to start its pharmacokinetic study by the end of the month, according to a company news release.

"We are pleased that the FDA, upon review of the clinical and non-clinical data package from the work of our partner Schering AG, has agreed with the design of our proposed pharmacokinetic study," chairman, president and chief executive officer Glenn L. Cooper said in the release.

The primary endpoint will require assessment of the average serum testosterone levels (Cavg) at steady state, measured in hypogonadal men receiving Nebido via intramuscular injection every 12 weeks, officials stated.

Following FDA recommendations, Indevus will measure its endpoint at the fourth injection to confirm steady state levels.

The company anticipates submitting a New Drug Application to the FDA in the second quarter of 2007.

Invedus recently entered the hypogonadism market with the acquisition of Delatestryl, a short-acting injectable testosterone product, according to the release.

Indevus, a Lexington, Mass.-based biopharmaceutical company, acquires, develops and commercializes products targeting medical specialty areas, including urology, gynecology and men's health.

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