Sprout Pharmaceuticals is trying again to win FDA approval for its drug often called the “female Viagra.” It is a treatment for hypoactive sexual desire disorder, or HSDD.
The Raleigh-based startup announced the refiling early Tuesday.
“This NDA resubmission marks the completion of the additional clinical studies requested by FDA,” said Cindy Whitehead, CEO of Sprout Pharmaceuticals, in a statement.
“The FDA has devoted significant resources to understand HSDD and the need for medical treatment. I believe that the Agency’s efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market. This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution.”
Sprout resubmitted a New Drug Application, a necessary step to win approval.
The Srpout drug is called flibanserin. If approved, it would be the first FDA-cleared treatment for HSDD.
The FDA rejected Sprout’s earlier iling in 2013, replying with a “complete response letter” that required additional information.
Sprout conducted two additional studies and included the results in the latest submission.
It already had been tested in three late-stage trials.
“In all trials, flibanserin demonstrated a statistically significant difference compared to placebo on three key endpoints: an increase of sexual desire; a decrease in distress from the loss of sexual desire; and an increase in the frequency of satisfying sex,” Sprout noted in a statement.
“The flibanserin safety profile has been well characterized in clinical trials. The most common side effects observed were dizziness, nausea and sleepiness.”
An ongoing battle
The ongoing saga of Sprout’s female libido drug illustrates the complicated politics and unresolved science surrounding women’s sexuality.
For decades, drugmakers have tried unsuccessfully to develop a female equivalent to Viagra, the blockbuster drug that treats men’s erectile dysfunction drug by increasing blood flow. But disorders of women’s sexual desire have proven resistant to drugs that act on blood flow, hormones and other simple biological functions.
Supporters of Sprout’s drug say women’s sexual disorders have been overlooked for too long by regulators at the Food and Drug Administration. But critics argue that women’s sexuality is too complex to be addressed by a single pill.
Sprout’s drug flibanserin is the first attempt to increase libido by acting on brain chemicals linked to appetite and mood. But the Food and Drug Administration has already twice rejected the drug because of lackluster effectiveness and side effects including fatigue, dizziness and nausea.
In an effort to break the regulatory logjam, groups sponsored by Sprout and other drugmakers have begun publicizing the lack of a “female Viagra” as a women’s rights issue.
“Women deserve equal treatment when it comes to sex,” states an online petition to the FDA organized by one such group, Even the Score, which garnered almost 25,000 supporters. The group’s corporate backers include Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals — all companies developing drugs to treat female sexual disorders. A spokeswoman for Blue Engine Media, the public relations group for Even the Score, declined to disclose how much of the group’s funding comes from companies. The group’s nonprofit supporters include the Women’s Health Foundation, the Institute for Sexual Medicine and other organizations.
Drugmakers frequently cite a 1999 survey in the Journal of the American Medical Association that found 43 percent of U.S. women had some type of sexual dysfunction.
(Capitol Broadcasting, the parent company of WRAL TechWire, is an investor in Sprout.)
(The Associated Press contributed to this report,)
