Guest post by Natalie Morrison, Senior Reporter at BioPharm Insight
The first ever FDA approval of a female sexual dysfunction (FSD) drug, Sprout/Valeant Pharmaceutical’s Addyi, has stirred up controversy among experts.
Some argue it was approved to appease women’s rights activists, not for its efficacy and safety. Others counter that clinical trials showing the drug induces on average 1.5 more sexually satisfying events (SSEs) in women with hypoactive sexual desire disorder (HSDD) shows it has the desired moderate effect. The goal is not to turn women into nymphomaniacs, they say.
In any case, Addyi’s approval has rekindled industry interest in the FSD space and once the dust settles all eyes will be on next-in-line products and whether they will become best-in-class. The closest to the finish line behind Sprout Pharmaceuticals (under a USD 1 billion acquisition deal by Valeant Pharmaceuticals) is Palatin Technologies, which expects Phase III data for its on-demand injectable HSDD drug bremelanotide in 3Q16.
Bremelanotide works on the melanocortin pathways, whereas Addyi inhibits serotonin. Experts told BioPharm Insight they would not anticipate any one drug to work in all HSDD patients. The question is which will be preferred by patients, they said.
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