[OneMedForum] BioSante Pharmaceuticals

Most people can rattle off the major drugs to treat male sexual dysfunction–Viagra, Cialis, Levitra. But ask somebody to name a drug for female sexual dysfunction, and you’ll probably get a blank stare. That’s because there are no drugs to treat decreased sexual desire in women.

BioSante Pharmaceuticals seeks to cater to this overlooked market with its pipeline of products for female sexual health, menopause, contraception and male hypogonadism. The company’s main products are LibiGel, a testosterone gel for women, and Elestrin, which is approved to treat menopause-related hot flashes.

LibiGel is in Phase III clinical trials for the treatment of female sexual dysfunction. Though testosterone is a male hormone, it is also present in women. Testosterone deficiency is known to decrease a patient’s sex drive. In a Phase II trial, LibiGel increased the number of satisfying sexual events by 238 percent compared to baseline. No serious adverse effects were observed, and LibiGel had a safety profile comparable to that of the placebo group. BioSante expects to submit a New Drug Application (NDA) for LibiGel in the middle of 2011. If approved, LibiGel would be the first product on the market to treat female sexual dysfunction.

The company’s other lead product, Elestrin, is already commercially available. Elestrin is a low-dose estradiol gel for the treatment of moderate to severe hot flashes related to menopause. Hot flashes are thought to be triggered by a drop in estrogen, believed to cause irregularities in the body’s temperature-regulating mechanism. Estradiol is identical to the estrogen that is naturally produced by the female body.

We talked with Stephen Simes, President and CEO of BioSante, at the 2010 OneMedForum. In this video, Simes discusses BioSante’s pipeline and financial status going into the new year.

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