Boehringer pulls ‘Pink Viagra’
pharmafile | October 11, 2010 | News story | Sales and Marketing | Boehringer, Girosa
Boehringer Ingelheim has discontinued development of its hypoactive sexual desire disorder drug Girosa after the FDA refused to approve it.
Back in June an FDA advisory panel questioned Girosa’s efficacy and believed the common side effects of dizziness and fainting outweighed its negligible benefits.
After three months of deliberation the FDA agreed with its advisory committee and has decided not to back the drug.
The German-based company still believes there is a place for Girosa, dubbed the ‘Pink Viagra’ by the media, for pre-menopausal women suffering with hypoactive sexual desire disorder (HSDD) and aims complete the two most advanced clinical studies for the drug.
Michael Sand, director of clinical research and global strategic leader of Girosa at Boehringer Ingelheim, said: “The need for a better understanding of HSDD and its possible treatment continues, and we hope the scientific and medical communities will build on the knowledge that Boehringer Ingelheim’s research has provided to find solutions for women who suffer with this disorder.”
The FDA based its decision on data from Boehringer’s two prospective, randomised, double-blind North American trials that compared two doses of Girosa with placebo in premenopausal women with HSDD for 28 weeks.
Change in the number of satisfactory sexual events from a four-week baseline measure to the 28 days prior to the final clinic visit were recorded, as were sexual desire scores culled from personal electronic diaries maintained by all patients in which they recorded sexual desire, sexual activity, and orgasms.
In both trials, the groups that used Girosa showed a significantly greater number of satisfactory sexual events than the placebo groups (a 1.6 point improvement from baseline in the Girosa group, compared with a 0.8 point improvement in placebo; P=0.005).
About 30% to 40% of women in the Girosa group reported a greater number of satisfactory sexual events, compared with 15% to 30% in the placebo arm.
However, both studies failed to demonstrate a statistically significant improvement on the co-primary endpoint of sexual desire, as measured by the e-diaries.
Boehringer said it will complete the two most advanced clinical studies to “add knowledge for the scientific community and women suffering with HSDD”.
The company also added that in view of the “broad range of therapeutic areas that the Boehringer Ingelheim pipeline currently comprises”, it will be able to re-allocate resources to other areas, such as stroke prevention, diabetes and oncology.
Ben Adams
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