(Bloomberg) -- Pharmaceutical companies seeking to develop drugs that increase women’s sexual interest and arousal now have a playbook from U.S. regulators that may boost the chances of getting treatments to market.
The Food and Drug Administration released a draft guidance Tuesday to inform drugmakers about its current thinking on the design of late-stage trials for such drugs. It’s an important step because the agency has so far approved just one treatment for female sexual desire: Addyi, a pill from Valeant Pharmaceuticals International Inc. that has drawn controversy and suffered from weak sales.
“Sexual dysfunction can adversely affect various aspects of life for a woman, including her relationship with her partner,” the FDA said. “There is a medical need for development of drugs with a favorable benefit-risk profile to treat women with sexual dysfunction.”
Addyi’s Struggles
The struggle to get Addyi to the market -- at least three FDA reviewers recommended rejecting it before it was approved in September 2015 -- highlighted the need for better guidance. The lack of sexual desire in women is more complex for drugmakers than men’s erectile dysfunction, a physical problem that can be treated with drugs like Pfizer Inc.’s Viagra that increase the blood flow to the penis. Addyi, in contrast, targets neurotransmitters -- similar to antidepressants -- that communicate information to the brain and can affect the mood.
The FDA held a first meeting in October 2014 to hear from female patients. The guidance makes clear the agency’s wariness regarding a measurement of desire known as the female sexual function index that has been used in clinical trials. The agency recommends primary study goals that measure the number of satisfying sexual relations, women’s distress level or the level or interest, desire or arousal.
Palatin Technologies Inc. is in late-stage testing for its female sexual-dysfunction drug, bremelanotide, which would be taken as needed. The goals of the trial include changes in satisfying sexual relations and the female sexual function index, according to the company. Results are expected to be released before the end of the year.
Addyi’s sales have been disappointing in part because of the risk of serious side effects, including severely low blood pressure and fainting that require women to refrain from alcohol while taking the daily pill. The efficacy of the treatment, bought by Valeant last year before the drugmaker faced major turmoils, was also questioned in studies.
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