In a little noticed move, the company that sells the Addyi pill for female sexual dysfunction recently won regulatory approval in Canada, thanks to a followup study designed to address a nagging safety question. But while the endorsement may set the stage for a commercial revival in the U.S., where the drug has been a spectacular flop, it’s not clear the findings will put the safety concerns to rest.
At issue is the extent to which women should drink alcohol while on the drug, since it must be taken every day to be effective. In fact, when it was first approved nearly three years ago by the U.S. Food and Drug Administration, the product labeling warned that alcohol and Addyi should not be taken together. But in approving Addyi, Health Canada decided only to place limits on that interaction.
This development may provide its maker, Sprout Pharmaceuticals, with the opportunity to make Addyi into a winner, after all. After the FDA approval in 2015, the company sold the pill to Valeant Pharmaceuticals for $1 billion, but the drug never took off. This was due to debate over safety and effectiveness, but also because Valeant was preoccupied with distracting scandals. Last fall, however, Sprout repurchased the rights.
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It seems that every member of the chief medical adviser’s office is female – along with, possibly, the chief adviser as well. Purely a coincidence, I am sure.