Following the completion of postmarketing studies for Sprout Pharmaceuticals’ Addyi (flibanserin), which is used to treat decreased sexual desire in women, the US Food and Drug Administration (FDA) has changed the labeling for the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely.
Specifically, the agency told women to discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. “Women should not consume alcohol at least until the morning after taking Addyi at bedtime,” FDA said.
FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released safety data last month
, purportedly showing how Addyi and alcohol interactions “resulted in no increased incidence of adverse events of special interest.”
But FDA noted late Thursday how in at least one study for the previously twice-rejected drug, there was data missing, and the “proportion of missing data increased with increasing alcohol dose. Furthermore, the peak time for the missing data occurred between one and four hours after taking Addyi and alcohol, which is the time when Addyi achieves maximum blood concentrations; this observation further supports the Addyi-alcohol interaction.”
And unlike in the real world, subjects in Sprout’s studies were carefully monitored, not allowed to stand when their blood pressure dipped too low and/or were instructed to go to bed right after taking Addyi.
“In the real world, safety measures such as these are not in place to prevent or provide immediate assistance to women experiencing” severe hypotension (low blood pressure) or syncope (passing out), FDA said.
“We consider the risk of severe hypotension/syncope when (1) Addyi and alcohol are taken at the same time, (2) Addyi is taken with moderate to strong CYP3A4 inhibitors, or (3) Addyi is used in patients with hepatic impairment,” the agency added in its safety labeling change order
Part of the label was also updated to note how in one of the alcohol interaction studies conducted by Sprout in healthy premenopausal women, Addyi alone and in combination with alcohol caused drowsiness in more than 80% of subjects. About 50% of subjects reported dizziness.
The label changes come as Addyi has failed to take off since it was first approved in 2015. Purchased for $1 billion in that same year, beleaguered Valeant Pharmaceuticals decided to then pull Addyi from the market in 2017 because of the slow sales. Last June, Sprout revived the drug again, slashing its price in half to $400 monthly