Pharma, Startups

Sprout raises $5M for drug to boost sex drive in women and resubmits NDA in increasingly crowded market

Sprout Pharmaceuticals’ quest to get approval for what would be the first drug to treat […]

Sprout Pharmaceuticals’ quest to get approval for what would be the first drug to treat sexual dysfunction in premenopausal women made a big step today. It has resubmitted its NDA to the U.S. Food and Drug Administration, according to a statement, resetting the path for the drug when it was under development at Boehringer Ingelheim. It’s hoping to make it the first, or at least one of the first, drugs of it kind on the market

But in what’s becoming an increasingly crowded market of drug companies hoping for success despite a disappointing track record, some wonder whether a drug will cure hypoactive sexual desire disorder.

The Raleigh, North Carolina-based pharmaceutical company also raised $5 million to advance flibanserin as a treatment for HSDD, according to a Form D filing with the U.S. Securities and Exchange Commission. It expects the FDA to take action before the end of 2013, the statement said.

This time around, the company has gathered more efficacy and safety data to support its application since the FDA submitted a complete response letter to Boehringer Ingelheim in 2010. A phase 3 study of 1,000 women concluded that flibanserin produced statistically significant improvements in the number of satisfying sexual events (and an increase in sexual desire compared with a placebo).

Although it sounds a lot like Pfizer’s drug Viagra for women, it does not share the same mechanism of action.

Several drug companies have poured millions upon millions of dollars in pursuit of a treatment for this condition. There’s been little to dampen their desire despite years of development that produced lackluster results failing to make their drug’s performance  much better than a placebo. Among other companies competing in this market is BioSante (NASDAQ:BPAX), which has a low testosterone gel designed to be absorbed by he skin, called Libigel. But that too has had its own clinical trial shortcomings. Emotional Brain is hoping for better results this summer for its drug Lybridos.

Some have questioned whether hypoactive sexual desire disorder is simply the product of depression or boredom and see therapy or maybe just honest discussion as more practical alternatives.

 

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