From the ashes of Boehringer Ingelheim's female sexual dysfunction research, Sprout Pharmaceuticals has risen and taken in capital from a $20 million round to give BI's female libido drug flibanserin another go with U.S. regulators. A flock of angel investors have decided to back the Raleigh, NC-based startup and its ambitious plan to seek another approval of the drug without doing additional clinical trials, WRAL Tech Wire reports.
The risky gamble could pay off if the company succeeds in winning approval for a drug that can combat underactive libidos in women, as there's currently no FDA approved sexual dysfunction drugs for females as there are for males with products such as Pfizer's ($PFE) Viagra and Eli Lilly's ($LLY) Cialis. Those products have fueled a blockbuster market for erectile dysfunction drugs, and developers hope to score big with female answers to those treatments.
As Sprout commercial chief Cynthia Whitehead tells the publication, the startup believes that a retooled new drug application with existing data from Boehringer's studies should be enough for FDA approval. This gambit might surprise those who have followed the program. FDA advisers shot down the drug as treatment for women's underactive libidos in 2010, saying that additional data would be needed to support the efficacy and safety of the drug. U.S. regulators followed up its panel's rejection of the drug with a Complete Response to Boehringer, which decided to scrap development of the program.
"There's a lot of pent up demand because there have been a lot of drugs for men over the last decade," Whitehead told WRAL Tech Wire. "It will be exciting to be the first one for women." And she said she expects to submit a new app to the FDA early next year.
To become the first company to win U.S. approval of a "female Viagra," Sprout will have to outpace BioSante Pharmaceuticals ($BPAX) and Apricus Biosciences ($APRI).
- get more in WRAL Tech Wire's article