Sexual health company Sprout Pharmaceuticals disclosed on Friday that the US FDA has revised the existing warnings and restrictions regarding alcohol use in women taking Addyi (flibanserin) for the treatment of acquired, generalised hypoactive sexual desire disorder (HSDD) and they may now safely consume alcohol.

The company added that Addyi is the first and only US FDA-approved treatment for acquired, generalised hypoactive (low) sexual desire disorder (HSDD) for premenopausal women based on three new Addyi alcohol interaction studies, which demonstrated no syncope or orthostatic hypotension requiring medical attention.

In clinical trials, Addyi, which is a novel, non-hormonal oral pill to be taken at bedtime, has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.

Following the US FDA order to lessen the alcohol restriction, the company developed a comprehensive Risk Evaluation and Mitigation Strategy (REMS) programme, prescriber and pharmacist certification. The change will ensure all elements of labeling are equally in line with all known scientific data through a standard appeal process.

Additionally, the new collected data has been presented to the International Society for the Study of Women's Sexual Health, International Society for Sexual Medicine and Sexual Medicine Society of North America and was submitted to the US FDA eight months ago, concluded the company.