Indevus is facing a major setback in its efforts to gain approval for Nebido. The drug treats male hypogonadism, a condition in which the testicles fail to produce enough testosterone. Indevus said it expects the FDA to formally request more safety information on the drug, which will include another Phase III trial. According to Indevus' release, the FDA wants data related to a reaction immediately following the injection--a known rare complication of oil-based depot injections. Indevus attributes the reaction to "improper injection technique." The additional trial will delay the drug's approval by 18 months. Wall Street was greatly displeased by the news and Indevus' stock took a 67 percent plunge in early trading.
"We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of Nebido given the large European experience. Rare coughing reactions have been well-described in the European product labeling of Nebido... From our verbal discussion with the FDA, we are not aware of any other approvability issues," said CEO and chairman Glenn L. Cooper in a statement.
- see Indevus' release on the delay
- read this article for more