Indevus Pharmaceuticals got slapped down hard this morning. The Lexington, MA-based company said today it expects the FDA to formally ask for more safety data that will require a new clinical trial before it will approve Nebido, a long-lasting testosterone replacement therapy for men with low levels of the male sex hormone. Shares of the company (NASDAQ: IDEV) sunk 66 percent to $1.40 at noon.
The FDA’s beef with Nebido is that, if injected improperly, it can cause rare, short-term coughing episodes, Indevus said today in a statement. The company’s clinical trials found one coughing episode out of 500 patients. In that case, the side effect resolved within 10 minutes and didn’t require medical attention, Indevus said. “We are very surprised and disappointed by the position the FDA is taking,” said Glenn Cooper, Indevus’ CEO, in the statement.
Indevus isn’t giving up, intending to pump more resources into another study to satisfy the FDA, Cooper said. That should take 18 months, followed by another 6-month review period by the agency before it can be cleared for sale in the U.S. (Indevus already has several other drugs for endocrinology and neurology applications on the market.)
Since Nebido is already approved in Europe and the side effect is described in the product label, the decision “flies in the face of logic,” because the FDA has power to require new surveillance of drug safety once a drug is on the market, said David Miller, president of Biotech Stock Research, an independent research firm in Seattle, in a note to clients this morning. It may be that “this division of FDA has decided they are uncomfortable approving new drugs,” that treat low testosterone levels, Miller wrote.