Canadian drug giant ,Valeant Pharmaceuticals International is planning a re-launch of Addyi, its so-called “pink Viagra”

Canadian drug giant ,Valeant Pharmaceuticals International is planning a re-launch of Addyi, its so-called “pink Viagra”

Quebec,June27:It’s been called a “billion-dollar lemon of a purchase,” a pill for a “fake” disease manufactured by drug companies.

Now, nearly two years after its controversial female libido pill was approved in the U.S, beleaguered Quebec drug giant Valeant Pharmaceuticals International is planning a re-launch of Addyi, its so-called “pink Viagra” and the first drug approved for hypoactive sexual desire disorder, or HSDD, in women.

Valeant agreed to hold off advertising Addyi on television or radio for 18 months when it was approved by the U.S. Food and Drug Administration in August 2015 after its third go-round before the drug regulator.

With that moratorium now lifted, Valeant is clear to launch drug ads and consumer “education awareness” campaigns experts say are likely to carry messages similar to the “elephant-in-the-bedroom” ads for the erectile dysfunction drug Cialis — that female sex problems are all-too-common and a pill exists to help give women the sex lives they deserve.

Chemically known as flibanserin, the drug is still being reviewed by Health Canada, more than a year after Valeant submitted it for approval.

  • On the eve of its release question remains: is ‘pink Viagra’ solving a problem that doesn’t exist?
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In the U.S., sales have been dismal, with roughly 23,000 prescriptions dispensed since the drug was released on the American market in October 2015, according to figures provided to the National Post by drug-market research firm IMS Health.

Viagra, in contrast, sold more than half a million prescriptions in its first month alone when it was launched in 1998.

Critics say Addyi’s sales reflect women’s unwillingness to take a pricey (US$800 a month) and risky drug that, according to published studies, produces, on average, one extra “sexually satisfying event” per month over placebo.

“Where are the crowds of women with low libido clamouring for Addyi,” members of PharmedOut, a Georgetown University Medical Center project, wrote in a recent for The Hastings Center.

“They never existed, except in a PR firm’s fantasy.”

Others say drug regulators have thrown up unnecessary barriers, including making Addyi available under a restricted access program that requires doctors and pharmacists to get special certification in order to prescribe or dispense the pale pink pills. Women also have to promise to never drink alcohol while taking the drug, which can cause low blood pressure and syncope, or a sudden loss of consciousness, side effects exacerbated when mixed with booze.

One Canadian researcher suggested the REMS (risk evaluation and mitigation strategy) and doctor-patient agreement forms seem designed to scare “the living beejeezus” out of women. “The FDA is being responsible ….. yes,” said Jim Pfaus, a professor of psychology at Concordia University who led some of the earliest studies measuring the effects of flibanserin on sexual desire and copulation, in female rats.

However, “some people are now arguing (REMS) was a scare tactic the FDA imposed because it didn’t particularly like being dragged back into this whole debate about whether HSDD is truly an unmet medical need,” said Pfaus, whose research the Canadian Institutes of Health Research supports but who has also received consulting grants from Boehringer Ingelheim, Addyi’s original developer.

There are some women for whom the drug works, Pfaus said, and others for whom it does not, and one challenge now is sorting out the “responders from the non-responders,” he said.

“The second issue is, what is a sexually satisfying event to a woman,” Pfaus said. “You could have a kissing session that was like the best you’ve ever had — is that an SSE? Some could say, wait a minute, there’s no penile-vaginal intercourse, therefore it’s not a sexual thing, it’s a foreplay thing.”

Pfaus believes Addyi isn’t sufficient enough to do anything on its own, adding female sexuality is “a much more sophisticated process” than the faulty hydraulics Viagra corrects by increasing blood flow to the penis.

However, Addyi may help enhance other interventions for women distressed because of low desire, Pfaus said, such as mindfulness therapy, couple or sex therapy.

I think itu2019s crazy because the data about the drug havenu2019t improved u2014u00a0if theyu2019ve done any kind of post-approval studies, we havenu2019t heard anything about it

Valeant, which acquired Addyi’s makers, Sprout Pharmaceuticals, for US$1 billion two days after the drug  won FDA approval after twice being rejected over safety concerns, declined several requests for an interview.

Despite the “pink Viagra” moniker, Addyi works on the brain, not the genitals. It has to be dosed every day, and not taken on demand like Viagra just before sex. However, while it targets neurotransmitters thought to affect desire, “there is no biological marker or threshold for abnormally low desire,” clinical psychologist Leonore Tiefer and Barbara Mintzes, a former University of British Columbia drug researcher now at the University of Sydney, wrote in after Addyi’s controversial U.S. approval. “What might feel low for one woman,” they argued, “could be normal for another.”

In an interview, Tiefer called Addyi’s value miniscule at best and said it seems “unbelievable” to her that Valeant may be planning an aggressive marketing campaign.

“I think it’s crazy because the data about the drug haven’t improved — if they’ve done any kind of post-approval studies, we haven’t heard anything about it,” she said.

The REMS program cites an early study involving 25 people — 23 of who were men — administered Addyi along with the equivalent of two to four glasses of wine consumed over 10 minutes in the morning. “Severe hypotension,” the REMS notes, “was observed.”

However, doctors like Canadian-born obstetrician-gynecologist Jen Gunter said the effect could be even more pronounced for women. “I mean it’s not like men and women react differently to alcohol or anything. Sigh,” Gunter . She also worried women might underestimate the risk of mixing the libido pill with ethanol. “None of this winking at your doctor — Oh yeah, I can’t have alcohol, wink,” she added in an interview with .  (Gunter also noted it took her a mere five minutes to complete the online REMS test for special certification.)

Others criticized the study for its unrealistic dosing, given most people drink at night, and flibanserin is to be taken at bedtime. In later studies, in which alcohol wasn’t restricted and Addyi was taken at bedtime, the incidence of syncope (fainting) was 0.4 per cent with flibanserin and 0.2 per cent with placebo.

Writing in the Canadian Medical Association Journal, University of Montreal researchers last year warned that, while Valeant won’t be able to promote Addyi in Canada using direct-to-consumer drug ads, which are banned in Canada, we can nonetheless expect “information” campaigns with messages “that it is imperative that women be sensitized to this pubic health problem.”

Valeant is already funding a new marketing campaign called , which, while not actually mentioning Addyi, offers a sexual health quiz (“how would you rate your level of sexual arousal   or ‘turn on’ during sexual activity or intercourse?) and video clips in which doctors describe seeing women with little or no interest in sex in their practices every day who feel “inadequate — as a woman, as lovers and as partners.”

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