Sexual dysfunction as an independent disease? As for men a major question is: will the drug be used for improvement of satisfaction above normal? In other words is Flibanserin a drug for performance a dope? For sure it will. But be careful without alcohol.
""Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," Woodock added. The FDA ordered a Risk Evaluation and Mitigation Strategies (REMS) program that mandates special training for prescribers.
The label will include a boxed warning to underscore the risks of severe hypotension and syncope among patients who drink alcohol while taking the drug and for women who use "moderate or strong CYP3A4 inhibitors" and those with liver impairments. Addyi is contraindicated for all such patients."
"All three trials conducted by the sponsor showed "statistically significant improvement" in the number of satisfying sexual events (SSE) and a reduction of sex-related distress in participants taking flibanserin compared with control participants, according to FDA reviewers. The sponsor drug also showed a median placebo-corrected increase of approximately 0.5-1.0 SSEs per month, from the median baseline of two to three events per month."
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