MELBOURNE, Australia—Acrux, a small Australian pharmaceutical company whose shares have never made a profit, is about to hit the big time after trial results of Axiron, a spray-applied testosterone treatment currently in development, exceeded benchmarks set by the U.S. Food and Drug Administration (FDA).
The Phase 3 trial “exceeded all of our expectations,” Acrux CEO Richard Treagus said in a conference call. “We believe this will generate significant revenue for our company from 2010 onwards.”
As seen from the extraordinary success of erectile dysfunction drugs such as Viagra and Cialis, products that address sexual potency are almost guaranteed to generate vigorous sales. Acrux stocks have already tripled this year in anticipation of the latest trials.
Other highlights from the latest Axiron trial included:
- 76 percent of subjects in the normal range after 15 days of treatment;
- Mood, sexual desire, sexual activity, sexual performance all showed significant improvement from baseline;
- For 75 percent of subjects, a single application to each armpit was the optimal dose;
- No treatment-related serious adverse events and a good skin safety profile;
- FDA agreed that Acrus may submit a new drug application in the U.S., with a target submission of late 2009.
If it has not done so already, the Acrux marketing department also might want to consider adopting the advertising slogan, “Spray It On, Get It On.”
For more information, visit the Acrux website.