RALEIGH –  Two decisions made by the Food and Drug Administration could be good news for Raleigh-based Sprout Pharmaceuticals, the making of the female sexual disfunction drug Addyi.

Early Wednesday, Sprout announced that the FDA has revised its warnings about the use of alcohol with Addyi.

Instead of a ban or “contraidication” on alcohol use, the FDA now says patients should not consume alcohol two hours before using the drug nicknamed the “female Viagra.”

The FDA also no longer requires that physicians that healthcare providers and pharmacies no longer must be certified through the FDA’s Risk Evaluation and Mitigation Strategy known as REMS to prescribe or dispense Addyi.

Sprout Pharmaceuticals

Sprout CEO Cindy Eckert praised the decisions.

“It’s a new day for women,” Eckert said in the announcement. “As the first-and-only FDA approved non-hormonal treatment for HSDD [Hypoactive sexual desire disorder] in premenopausal women, Addyi offers a critical treatment option to help those struggling with this condition.

“No longer are women stuck choosing between treatment and a glass of wine. Outside of the day we broke through with the first approval in this category, this represents the biggest shift toward greater access for women in need.”

Eckert has been embroiled in negotiations with the FDA about the previous limits on Addyi for months.

“I spent $10 million just to do additional scientific work on Addyi and alcohol interaction,” Eckert told Fortune magaizne in an interview published Wednesday.

“On the basis of those findings, the FDA has ruled they will lift the alcohol contraindication.”

Sprout recently disclosed $15.9 million in new venture capital to finance expected growth of the company.

Fortune reported that Addyi had raised $20 million in all.

For more information about the drug, visit the Addyi website.

Raleigh’s Sprout Pharmaceuticals, makers of ‘female viagra,’ raise $15.9M

Back in 2015, Eckert and investors sold the business to Valeant Pharmaceuticals for $1 billion, only to buy it back two years later when the Canadian venture dumped the investment.

That wasn’t the only hitch.

Concerns arose about its reaction with alcohol after the FDA warning against mixing the two. Meanwhile, Health care providers faced certification hurdles trying to prescribe it.

The company subsequently released three studies affirming its safety with alcohol, and relaunched the pill at half the original price — $400, down from $880 previously.

It also raised $4.5 million from 203 investors in early 2018.