Each 1000mg injection of Nebido would only need to be provided once every 12 weeks, as compared to the current injectable therapies which typically require an injection every two to three weeks, according to the filing.
The NDA submission follows the June 2007 announcement of positive results from the company's Phase III pharmacokinetic trial for Nebido. In addition to the data from this US trial, the NDA includes the results of the European clinical trials database (originally generated by the company's partner, Bayer Schering Pharma AG, Germany) which has formed the basis for the approval of Nebido in over 75 countries to date.
The US testosterone therapy market is currently estimated to be in excess of $550 million. Of the approximately 340,000 men currently receiving therapy, approximately 130,000 utilize the existing injectable therapies that must be given every two to three weeks.