A data monitoring committee has recommended the continued study of BioSante's LibiGel as a treatment for sexual dysfunction in women following the review of positive safety data from a Phase III clinical trial. The good news caused BioSante's shares to go up 5 percent in premarket trade, Reuters notes.
The DMC reviewed all unblinded adverse events in the safety study, including all serious adverse events and adverse cardiovascular and breast cancer events. To date, there have been no deaths, six adjudicated cardiovascular events and four breast cancers reported. The LibiGel Phase III development program will therefore continue as planned. BioSante is targeting mid-2011 for the submission of a new drug application to the FDA, according to a company statement.
"This is very good news for BioSante and for women since LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in surgically menopausal women," Stephen Simes, BioSante's president and CEO, says in a statement. "We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need, also referred to as female sexual dysfunction (FSD)."
BioSante also is conducting two double-blind, placebo-controlled LibiGel Phase III efficacy trials. The drug's development program got a boost last year through BioSante's merger with Cell Genesys. BioSante estimated at the time that the merger will bring in between $20 million and $25 million to help fund development of the drug.
- read BioSante's release
- check out Reuters' coverage