Studies show Addyi, the ‘female Viagra,’ is safe with alcohol, Raleigh-based Sprout says

RALEIGH – Three new studies affirm that Addyi, the so-called “female Viagra” from Raleigh based Sprout Pharmaceuticals, is safe and effective with alcohol even though the FDA warns against mixing the two, the company says.

Addyi

“The additional insights provided by these three new studies are invaluable for a more comprehensive understanding of Addyi for safe use,” said Addyi CEO Cindy Eckert.

“This additional data contextualizes and further clarifies the relationship between Addyi and alcohol. We thank all of the women who participated in these informative studies.”

Sprout announced the study results Thursday. Addyi targets Hypoactive (low) Sexual Desire Disorder (HSDD) in premenopausal women.

The company described the study results as “important new Addyi safety and tolerability data.”

It noted that it is sharing the results with the FDA to “inform safety labeling.”

Addyi includes an FDA-approved “package insert” hat warns against consumption of alcohol with Addyi, citing health risks.

Addyi’s own website declares:

What is the most important information I should know about Addyi?

Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take Addyi and:

“drink alcohol. Do not drink alcohol if you take Addyi.
“take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over
“the-counter medicines, or herbal supplements while taking Addyi until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking Addyi.
“have liver problems. Do not take Addyi if you have liver problems.”

However, Sprout says the “three studies advance the understanding of the safety and tolerability of Addyi for the FDA, the medical community and women in need of treatment.”

Study summaries

Here’s how Sprout summed up the three studies:

“The first study resulted in no increased incidence of adverse events of special interest in the women when they received Addyi (flibanserin) 100mg a couple of hours post alcohol compared to when they received placebo post alcohol.”
“A second study involving 96 healthy premenopausal women was designed to assess the effect of the approved dose of Addyi co-administered with varying doses of alcohol on dizziness, syncope, and hypotension. … No episodes of syncope or orthostatic hypotension requiring medical intervention were observed during this study.”
“[A] dose-timing study in 64 healthy premenopausal women designed to evaluate the impact of the timing of alcohol consumption on the safety and tolerability of Addyi was also conducted. … Consistent with the findings of the other studies there were no episodes of syncope or orthostatic hypotension requiring medical intervention observed in this study.”

Test results were shared with the FDA as well as the International Society for the Study of Women’s Sexual Health (ISSWSH), International Society for Sexual Medicine (ISSM) and Sexual Medicine Society of North America (SMSNA).

Sprout was sold to Valeant Pharmaceuticals for $1 billion in 2015 then reacquired the company two years later.

Addyi received FDA approval in 2015.

Since reacquiring Addyi, Sprout has moved to drastically cut its cost to as low as $25 a month with insurance coverage or $99 via homed delivery. Addyi was priced at several hundred dollars before Sprout regained control.

Valeant basically returned rights to Addyi at virtually no cost and provided a $25 million loan to Sprout for a relaunch of the company as a separate venture.