Likewise, current testosterone shots are too short-acting, requiring men to inject themselves weekly or bi-weekly. These products can also cause excessive spikes in testosterone levels, leading to unwanted side effects.
Indevus' answer to these problems is Nebido, a long-acting testosterone injection that lasts three months and doesn't cause the nasty hormonal spikes of current injectables. Nebido was filed with the Food and Drug Administration at the end of August. The agency should decide on the drug's approval by the end of next summer. With just four shots a year, Nebido would allow men to treat their hypogonadism without worrying about fluctuating testosterone levels and freeing them up from having to apply a daily gel. At the ThinkEquity conference, Indevus estimated there are about 130,000 men using current testosterone injections. When Nebido is approved, these men should be easily switched over. After that, Indevus plans to target the approximately 210,000 men currently using gels or patches. The company doesn't expect to convert a majority of gel users, but there will be a significant number of men who prefer four easy injections per year. Nebido is already approved and used in Europe, where it is marketed by Bayer Schering without any significant safety issues. One concern raised at last week's conference, however, was the fact that a long-acting testosterone therapy might prove problematic for men who are found later to have rising PSA levels, a danger sign for prostate cancer. (Testosterone "feeds" prostate cancer cells, which is why prostate cancer patients usually go on testosterone-dampening therapy.)


