Still no satisfaction: New JAMA study renews debate over Valeant's lagging Addyi

The "little pink pill" for women is back in the headlines. The controversial female libido drug Addyi, which Valeant ($VRX) bought from Sprout Pharmaceuticals for $1 billion shortly after its FDA approval last fall, had been on the backburner for months, thanks to less-than-stellar launch sales and more pressing corporate parent issues. However, Addyi moved front and center again this week in a new firestorm brought about by a study from the Journal of the American Medical Association (JAMA).

In a study published Feb. 29, researchers wrote that Addyi's effectiveness corresponded to an average of only one-half additional satisfying sexual encounters per month for its users. The research evaluated 5 published and three unpublished studies that looked at the efficacy and safety of Addyi (flibanserin), used to treat hypoactive sexual desire disorder in more than 6,000 women.

A JAMA editorial column in the same issue then fanned the flames, asking, "Given the benefits and harms, why did the FDA get to yes?"

It's a question that's been asked before.

When Addyi was initially approved by the FDA in August when it was under Sprout's guidance--after having been turned down twice before--critics charged that it was public relations and marketing, not science, that played the key role. The women's rights advocacy group Even the Score, of which Sprout was a member, was formed after the second rejection of Addyi and lobbied intensely for its approval, claiming gender bias in sexual dysfunction drug availability for women versus men.

Even the FDA in its approval said the drug provided only "modest" efficacy and gave Addyi a black box warning regarding its risks of severe low blood pressure and fainting spells made worse by the use of alcohol.

Several groups led by physicians pleaded with the FDA in the pre-approval days to reject the drug, with one charging the "unprecedented and unwarranted manufacturer-funded public relations campaign" unduly influenced the advisory committee, according to The New York Times.

The JAMA editorial concluded, the FDA drug approval process needs "to deliver good decisions based on adequate evidence" and in that regard "the flibanserin saga is unsatisfying."

Sales of Addyi have been slow, with Bloomberg reporting in the first few weeks only 227 prescriptions filled. More recently, Wells Fargo analyst David Maris questioned Valeant's purchase of Sprout saying "we are concerned that Valeant has overpaid for Addyi," in an investment note published by The Wall Street Journal.

When Addyi was initially approved, it was with the caveat that it would not do any DTC advertising for 18 months. However, after Valeant's purchase, then-CEO Cindy Whitehead told Bloomberg that the DTC agreement could change under new ownership. Valeant has delayed its fourth-quarter reporting, but in its third-quarter report wrote there are "no plans for direct to consumer (DTC) advertising at this time." Whitehead had stayed on after the Sprout acquisition, but left the company in December.

In the meantime, press coverage--old and renewed--promises to keep the pink pill in the media without need for paid placements.

- see NYT's new and previous articles
- read Bloomberg story
- see WSJ financial coverage