- A year-long campaign by Sprout Pharmaceuticals to allow women to drink while taking Addyi, a pill for hypoactive sexual desire disorder, has resulted in a partial success for the drugmaker.
- The Food and Drug Administration said Thursday it has revised the black box safety warning for the drug, which will now warn patients to wait at least two hours to take Addyi if they've consumed alcohol. But the agency also detailed a lengthy, contentious back-and-forth with Sprout as the drugmaker consistently demanded the warning's full removal.
- Failing to reach an agreement with Sprout, regulators ordered the change. "In those rare cases, such as with Addyi, we have important authorities to compel companies to make safety labeling changes that are critical for the safe use of an approved product," said Julie Beitz, a director for the FDA's Office of New Drugs.
The dispute between Sprout and the FDA stems from competing interpretations of the post-marketing studies on Addyi (flibanserin), testing whether taking the drug with alcohol led to cases of low blood pressure and fainting.
The FDA found "several concerning cases" of hypotension and syncope during its initial review of Addyi in 2015. Those were sufficient for the agency to issue an approval with a boxed warning, stating alcohol must be avoided in women treated with the Sprout pill. It also established a Risk Evaluation and Mitigation Strategy, or REMS, used to ensure medicines are distributed and prescribed safely.
Sprout wanted the warning to disappear altogether in a proposed label change in March 2018, which kicked off several rounds of discussions with the FDA.
But the private North Carolina-based biopharma wasn't able to persuade the agency, as regulators raised concerns with the design of an FDA-required post-marketing study.
That study looked at women who took Addyi and concurrently drank alcohol. While the study found no women with syncope or hypotension requiring intervention, the FDA took issue with inadequate measures to assess risk.
Specifically, the trial's protocol required women experiencing symptoms of low blood pressure, such as dizziness, to lay down and wait. Researchers then took blood pressure after the women's blood pressure numbers recovered, the agency said.
"As a result, the data collected had missing or delayed blood pressure measurements from these women while standing," the agency said in an April 11 statement.
According to a summary of their communications, Sprout argued that hypotension and syncope do not classify as serious adverse reactions, and therefore do not warrant a black box warning. Additionally, the drugmaker said this post-marketing study registered no events of severe hypotension or syncope.
While the warning will remain, Sprout won a smaller concession. Another post-marketing study found the risk of these side effects was reduced when women waited at least two hours after consuming up to two alcoholic drinks before taking Addyi.
The FDA adjusted the boxed warning based on that result, narrowing the contraindication of alcohol to cases of taking Addyi within two hours of consuming alcohol.
The regulatory tiff follows a ping-pong ownership for Addyi. Valeant Pharmaceuticals, now Bausch Health, paid $1 billion in 2015 to acquire the drug, only to sell it back two years later.
In a statement, Sprout called the labeling change a positive step, but also said the update makes the REMS program "inconsistent" with the label, since it requires women to sign a consent saying they will not drink while on the drug. The company said it will continue discussions with the FDA.