- Category: News
- Published on Thursday, 24 February 2011 16:34
- Written by L. Tacita
- Hits: 551
The first enrollment for Libigel Phase III trials was completed this week and the company announced the next wave will begin soon. As before, the company hopes to get long-term data about the health effects of the drug in post-menopausal women. FDA regulations require the company know about the potential long-term effects of the drug before a company can gain FDA approval.
“LibiGel is in development for the treatment of female sexual dysfunction(FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product,” the company said in a press release to Business Wire.
Biosante has enrolled 2,869 women in the study, which will take five years to fully complete. It is not known if this will affect the companys plans to apply for FDA approval of the drug in 2013. Official statements from the company have focused on using the drug in post-menopausal women with declining libido. No press releases have mentioned the word Asexual and the studies do not mention the effects of premenopausal women.
Press releases have focused on the investing side of the product rather than the medical side. The market for a female viagra is valued at over $2 billion, according to Forbes.com.