Valeant Pharmaceuticals Takes Over ‘Female Viagra’ makerSprouts Pharmaceuticals

The drug will also bear a boxed warning that women should not drink or take certain types of other medications, including antifungal drugs, because of an interaction that can cause low blood pressure and fainting.

Sprout Pharmaceuticals, a startup that in 2010 purchased the rights to sponsor flibanserin’s FDA application, said it expects to make Addyi available to patients starting mid-October.

It took another rejection from the FDA in 2013 before Sprout could figure out how to meet with the agency’s criteria and move the drug along toward approval, which it finally achieved last week. Its latest decision comes after an advisory panel concluded in June that it should be approved with strict measures in place.

Addyi is the first approved drug for HSDD (which used to be called female sexual dysfunction and female sexual arousal disorder). The drug doesn’t actually function like Viagra, which relaxes muscles and increases blood flow; rather, Flibanserin treats hypoactive sexual desire disorder, and functions more like an antidepressant.

The sale is a big triumph for Robert and Cindy Whitehead a couple that have a long history in the pharmaceutical sector who formed Sprout acquire Addyi after the FDA declined to approve it and it was abandoned by its previous owner.

Once more, the exact mechanism that is triggered by flibanserin or Addyi is not known. Instead it helps rebalance the chemicals in a woman’s brain to restore their desire for someone to whom they are attracted.

How effective the first prescription libido drug to come to market will be for women remains to be seen, but its maker is already set to reap financial gain. Valeant’s method is to develop through acquisitions. Physicians prescribing Addyi and pharmacies selling it must be certified under a Risk Evaluation and Mitigation Strategy (REMS) program and counsel patients on the risks.

As per the reports, Valeant would be paying $500 million in cash.

Michael Pearson, Valeant chairman and CEO, was on CNBC to discuss the deal and how the company plans to market Addyi. Now, the company is widening its reach in the consumer market with a nominally historic (and quite controversial) female sexual dysfunction medication.

It’s also the only drug under the Sprout Pharmaceutical umbrella, approved or in trials.

Despite those restrictions, critics still say the FDA capitulated to industry-developed standards of sexuality, setting a unsafe precedent for future approvals.

She still thought the drug had the potential to be useful for women with HSDD.