15 April 2019 - - The US FDA has decided that existing warnings and restrictions regarding alcohol use in women taking Addyi (flibanserin) for the treatment of acquired, generalised hypoactive sexual desire disorder are overly restrictive and overstate the risk of alcohol interaction, US-based Sprout Pharmaceuticals said.

This decision was informed by three new Addyi alcohol interaction studies which demonstrated no syncope or orthostatic hypotension requiring medical attention. This 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 FDA eight months ago.

Sprout received the FDA ordered Addyi labeling change to lessen the alcohol restriction on April 11, 2019.

The label change, once implemented, will ensure that healthcare providers and patients alike have confidence to make accurate, informed treatment decisions with study findings.

Sprout Pharmaceuticals has chosen to continue discussions with the FDA to ensure all elements of labeling are equally in line with all known scientific data through a standard appeal process.

This includes the now, inconsistent REMS program that requires healthcare providers and pharmacies to be certified to prescribe or dispense Addyi and women to sign a consent they will not drink when given a prescription for the drug.

Sprout Pharmaceuticals is focused solely on the delivery of a treatment option for women with HSDD.

Addyi is the first and only FDA-approved treatment for acquired, generalised hypoactive sexual desire disorder for premenopausal women.

In clinical trials, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.

The most common adverse events among patients treated with Addyi were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.

Hypotension, syncope, and central nervous system depression were seen with Addyi alone and more frequently when co-administered with alcohol in the morning, or certain other drugs. Alcohol consumption within two hours of taking Addyi is contraindicated.

With the FDA, Sprout Pharmaceuticals developed a comprehensive Risk Evaluation and Mitigation Strategy program, including prescriber and pharmacist certification, to ensure safe use of Addyi.

Addyi is a novel, non-hormonal oral pill to be taken at bedtime.