Biotech Values

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[FDA Guidance for Industry] Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM526362.pdf

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The Food and Drug Administration released a draft guidance Tuesday to inform drugmakers about its current thinking on the design of late-stage trials for such drugs.

The agency has so far approved just one treatment for female sexual desire: Addyi, a pill from Valeant Pharmaceuticals International Inc.

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.