It's been quite a week for little Sprout Pharmaceuticals.
On Tuesday, the 34-employee, closely held North Carolina company won approval of the first drug to treat female sexual dysfunction in the U.S. after weathering two previous rejections.
Thursday, it got acquired for a cool $1 billion by drug giant Valeant after what Valeant CEO Mike Pearson says were just three weeks of discussions.
As the smoke clears for Sprout and its drug, Addyi, should we expect to see feminine versions of those classic Viagra and Cialis ads?
Probably not, or at least not any time soon.
Sprout CEO Cindy Whitehead said the company told the Food and Drug Administration that it wouldn't market Addyi directly to consumers for 18 months—a time she said will instead be spent communicating with doctors and increasing the public's awareness of the condition Addyi aims to treat: Hypoactive Sexual Desire Disorder, or HSDD.
American Enterprise Institute's Dr. Scott Gottlieb said that's not an unusual arrangement with the FDA, particularly on a drug whose safety/efficacy balance may not be as much heavier on efficacy as regulators would like. (The side effects for Addyi include low blood pressure and fainting, made worse by consumption of alcohol.)
"It's not uncommon to see companies make voluntary concessions not to engage in direct-to-consumer advertising for a period of time after an approval," Gottlieb, formerly the FDA's deputy commissioner of medical and scientific affairs, said Thursday.
"We see this more and more with primary care drugs; the agency's concerned about a drug launch being too fast out of the gate, if you will, too many people using a drug right away, before doctors really have a clear understanding of the risk-benefit profile and how to prescribe the drug safely, and before consumers have that understanding," Gottlieb said.
Valeant's Pearson said on CNBC's "Squawk Box" Thursday that the company likely will use TV ads to help sell the drug—but that they may not be branded. So instead of "Ask your doctor about Addyi," consumers may hear "Ask your doctor about HSDD."
Communications to consumers may point them to a five-question diagnostic screen for HSDD that aims to rule out other causes of low libido, Sprout's Whitehead said.
"HSDD is not just low desire," Whitehead said in a telephone interview. "As much press coverage as this has received, this will screen out a lot of women who think this is the 'female Viagra.' "
Addyi, unlike Viagra, is "not a quick fix," Whitehead said. Viagra is prescribed for men for erectile dysfunction, is taken in the moment when needed, and stimulates blood flow. Addyi is taken chronically, once every day, and affects brain chemicals.
But in Addyi's case, even if the drug name isn't mentioned, awareness of the condition it treats will inevitably lead back to one spot, said Erik Gordon, a clinical assistant professor focusing on the pharmaceutical industry at the University of Michigan Ross School of Business.
"They say ask your doctor, then your doctor's going to scratch her head and say, 'Oh, I know what you're talking about: the only thing I can prescribe for your condition.' "
Addyi is expected to be available in the fourth quarter.
CORRECTION: The University of Michigan's business school is the Ross School of Business.