Sprout Pharmaceuticals’ Female Viagra Closer to Becoming Publicly Available

The experimental drug flibanserin, made by Sprout Pharmaceuticals, is at the center of a regulatory controversy.

The experimental drug flibanserin, made by Sprout Pharmaceuticals, is at the center of a regulatory controversy.

Sprout Pharmaceuticals has developed what they’re calling the Viagra for women. The new drug, named Flibanserin, purports to treat hypoactive sexual desire disorder (low sex drive, in other words) in pre-menopausal women. So far, $50M has been raised in preparation for the drug’s launch, and the Food & Drug Administration (FDA) has approved its benefits/risk profile.

The drug, now known as ADDYI, has had a long road thus far:  The drug was first rejected in 2010, when it was determined that the risks outweighed the dubious (at the time) benefits. Sprout began working on the drug in 2011, after being sold by the drug’s initial developer Boehringer Ingelheim. In December 2013, the FDA had rejected the drug for the second time.

In February 2014, the FDA wanted to see more tests done, specifically how the drug behaved when used with other medications. (Almost 10% of women taking the pill reported sleepiness during the trial.) The company resubmitted New Drug Application (NDA) this past February. The “little pink pill” was approved by an FDA advisory committee (done one step before final FDA approval), provided that more safety restrictions were added.

So far, Flibanserin/ADDYI has been tested on 11K+ women, and claims to be the “one of the most studied women’s health products in history.” Here’s what Sprout found after some recent trials:

In three 24-week randomized Phase 3, six-month, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years, ADDYI consistently demonstrated a highly statistically significant difference over placebo on three key endpoints, including increase in sexual desire, decrease in distress from the loss of sexual desire and increase in the frequency of satisfying sex. Women treated with ADDYI showed significant improvements at every point of measurement in all pivotal clinical trials, with benefits seen as early as four weeks and sustained over the 24-week treatment period.

It’s too early to know when the drug will hit the public market. But it’ll be interesting to see how it performs (haha).

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