Sprout's female libido drug Addyi back in FDA's crosshairs years after controversial approval

Sprout's Addyi scored FDA approval in 2015 as the first prescription medicine for premenopausal women diagnosed with low sexual desire disorder. (Sprout)

Sprout Pharmaceuticals' female libido drug Addyi has traveled a winding path through FDA gatekeepers, multiple M&A deals, marketing restrictions and more. With a possible new safety flag, the controversial medicine could be set for even more scrutiny.

In a rundown of potential new safety concerns on approved products, the FDA flagged the Addyi for possible risks of drug hypersensitivity. The FDA said it is "evaluating the need for regulatory action."

The latest chapter in Addyi's history comes after several relatively quiet years for the drug. Back in 2015, the medicine scored FDA approval and became the first treatment for premenopausal women diagnosed with low sexual desire disorder. Critics said the drug's clinical data didn't support an approval and that the medicine posed safety risks. Advocates said women needed an option to increase sexual desire and pointed to the multibillion-dollar men's sexual health field as being inequitable. 

RELATED: Valeant admits defeat on Sprout, trading $1B buy for 6% royalty on a drug that's not selling

Right on the heels of the approval, Valeant—now known as Bausch Health—scooped up Addyi maker Sprout for $1 billion in cash. Valeant, notorious for price hikes and M&A, never made the launch work. It eventually returned the drug's rights to Sprout's original owners in exchange for a small royalty. Valeant later rebranded after a series of scandals of its own.

At launch, the FDA restricted Addyi marketing and added a Black Box warning over risks of drinking alcohol while on the medicine. And since the Addyi approval, a competitor from Amag called Vyleesi has hit the scene. 

RELATED: AMAG wins FDA nod for Vyleesi. Could it be the ‘female Viagra’ that Addyi never was?

Addyi is far from the only controversial FDA approval in recent years. Most notably, the agency just approved Biogen's Alzheimer's drug Aduhelm under somewhat similar circumstances of questionable data and pressure from patient advocates. That approval has opened a Pandora's box of repercussions as the FDA's acting chief has called for an investigation into the agency's approval, lawmakers are probing Biogen and insurers are pushing back.