Health Canada approves ‘Viagra for women’ pill

Canada has approved the first “Viagra for women” pill — and, to the alarm of some experts, loosened restrictions around alcohol that have contributed to the drug’s lacklustre sales in the United States.

Health Canada says Addyi’s safety when mixed with booze was originally tested in a single study involving almost entirely men, and that a more recent women-only study suggests the drug doesn’t interact as badly with alcohol as believed.

In Canada, the libido pill will come with a warning to women to “limit” their alcohol consumption.

That’s in stark contrast to the U.S., where the drug is only available under restrictions. Women there are required to promise they’ll abstain from alcohol while on the drug because of risks of severe low blood pressure and fainting.

“I’d be shocked with the alcohol limits having been loosened (in Canada) as every presentation I’ve ever seen on Addyi has come with very strict instructions to abstain completely,” the University of British Columbia’s Lori Brotto, an international leader in female sexual desire, said in an email.

Addyi is the first prescription drug in the world designed to treat hypoactive sexual desire disorder, a controversial diagnosis some say pathologizes women for not fulfilling a certain sexual norm. Critics have also argued Addyi isn’t meaningfully superior to placebos, producing, on average, one extra “sexually satisfying event” per month.

Unlike Viagra, which works on the mechanics of erections by improving blood flow to the penis and is taken on an as-needed basis, Addyi is said to “adjust” brain chemicals involved in sexual interest and desire, as long as women take it every day. The exact way in which it works isn’t known.

The drug had been under review by Health Canada for more than two years. The federal agency issued a “notice of compliance” late last month, the Post learned. The U.S. Food and Drug Administration twice rebuffed Addyi before granting approval in 2015, and only after lobbying from a “grassroots” campaign called Even the Score — funded by Addyi’s makers, Sprout Pharmaceuticals — that accused the regulator of being sexist for approving sex medicines for men, but not for women.

Days after the FDA’s green light, beleaguered Quebec drug giant Valeant Pharmaceuticals bought Sprout and its sex drug for US$1 billion.

Then, last November, in a bizarre twist, Valeant gave Sprout back to its former shareholders in exchange for a six per cent royalty on global sales of Addyi starting in May 2019. Valeant also gave Sprout2 Inc. a $25-million loan to cover initial operating expenses.

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