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Addyi, the So-Called ‘Female Viagra,’ Now on Store Shelves

Female viagra

Addressing sexual dysfunction on the part of either partner can help to preserve relationships that might otherwise founder.

Addyi, the first FDA-approved drug to treat hypoactive sexual desire disorder (lack of desire) in women, hit pharmacy shelves in mid-October 2015. Because of lingering questions about the medication’s cost, insurance coverage, and side effects, it is unlikely that the drug’s availability will trigger a stampede of women headed for the drugstore.

Also likely to slow the pace of Addyi’s sales are some conditions that the U.S. Food and Drug Administration attached to its approval of the drug in August. Because of concerns about the medication’s possible side effects, the FDA said that physicians and pharmacists must be certified in the agency’s Risk Evaluation and Mitigation Strategy (REMS) program before they can prescribe or dispense the drug.

Boxed Warning Mandated

FDA’s approval also mandates the inclusion of a boxed warning on the drug’s label and package inserts alerting potential users to the danger of using Addyi when alcohol is being consumed. Concurrent use of flibanserin, the drug’s active ingredient, and alcohol can sharply increase the risk of a sharp drop in blood pressure and/or fainting. The boxed warning also must advise against Addyi use by those with liver impairment, as well as those who are taking certain other medications that interact adversely with Addyi.

Some market observers have voiced optimism that the restrictions placed on Addyi may encourage other pharmaceutical researchers to attempt to develop similar drugs that help to increase women’s sexual desire without some of the adverse effects attributed to Addyi.

What Will It Cost?

When it comes to the cost of Addyi for consumers, much depends on the ultimate decisions of health insurers about whether or not they will reimburse their insureds for the drug. An article posted at the website of CBS SF Bay Area estimates that the drug will cost women with prescription coverage roughly $20 a month out of pocket. In the immediate aftermath of FDA’s approval of Addyi, Anthem Inc. indicated that it would cover the new drug, while other major health insurers, such as Aetna and Cigna, and drug benefits managers said they had not yet decided on coverage. Headquartered in Indianapolis, Anthem is the largest for-profit managed health care company in the Blue Cross and Blue Shield Association.

Female viagria

It remains to be seen whether Addyi lives up to its hype, increasing sexual desire in women who have lost interest in sex.

Although Addyi has been widely referred to as “female Viagra” or “pink Viagra,” the drug has very little in common with the Pfizer drug that treats erectile dysfunction. While Viagra and other PDE5 inhibitors, such as Cialis and Levitra, temporarily improve blood flow to the penis to facilitate the erectile process, Addyi works on brain chemistry to increase female sexual desire.

Rebalances Neurotransmitters

As explained by Cindy Whitehead, CEO of Sprout Pharmaceuticals, Addyi helps to increase female sexual desire by rebalancing neurotransmitters in the brain. The German-based pharmaceuticals giant Boehringer Ingelheim was the first to develop the drug, the rights to which it sold to Sprout after the FDA turned down the German firm’s petition to market flibanserin.

In a 2011 study published in “The Journal of Sexual Medicine,” Boehringer researchers and Stephen Stahl, a psychologist at the University of California, undertook to explain how flibanserin works. To reduce levels of serotonin, a neurotransmitter believed to inhibit sexual desire, flibanserin targets two serotonin receptors in the brain. One of the two, known as 5-HT1A puts the brakes on serotonin production, while the other, 5-HT2A, accelerates the body’s production of serotonin. Flibanserin, the active ingredient in Addyi, stimulates the 5-HT1A receptor, putting the brakes on serotonin production, and inhibits the 5-HT2A receptor, further reducing serotonin output.

Other Neurotransmitters Increase Libido

With serotonin production cut back, brain levels of dopamine and norepinephrine increase. These two neurotransmitters are believed to increase sexual desire, so the overall effect of flibanserin is to fire up the libido in women who seem to have lost an interest in or desire for sex.

Another significant difference between Addyi and the PDE5 inhibitors are the frequency with which these drugs are to be taken. With the exception of Cialis for Daily Use, PDE5 inhibitors should be taken only as needed and usually 30 to 60 minutes before the beginning of sexual activity. However, to be effective Addyi must be taken daily and for a few weeks before its effects begin to be felt. Women who have taken the drug for eight weeks with no positive results are advised to discontinue Addyi.

Female Viagra

In August 2015, the FDA approved Addyi for the treatment of hypoactive sexual desire disorder, the most common form of female sexual dysfunction.

May Prompt Women to Seek Help

Addyi not only paves the way for further research into medications to treat HSDD and other forms of female sexual dysfunction, but it also may encourage women who have been struggling with decreased sexual desire to discuss the problem with their doctors. In an interview with The New York Times, Lauren Streicher, M.D., associate professor of clinical obstetrics and gynecology at Northwestern University, said she thought the introduction of Addyi would “change the conversation that’s taking place in medical offices across the country.”

If the marketing of Addyi prompts more women to open up about their problems with sexual desire, it will in many respects duplicate the phenomenon that occurred after the introduction of Viagra in 1998. In the wake of the male drug’s introduction, men seemed more willing to discuss their sexual problems both with their doctors and others. Prior to the introduction of the little blue pill and its early marketing campaign, the expression “erectile dysfunction” was hardly used at all among the general public. However, Viagra and similar drugs that have followed encouraged men to be more open about their sexual problems, including not just impotence but also premature ejaculation, delayed or inhibited ejaculation, and decreased sexual desire.

Valeant Acquires Sprout

Only two days after FDA’s approval of Addyi, Quebec-based Valeant Pharmaceuticals International announced that it had entered into a definitive agreement to acquire Sprout for roughly $1 billion in cash and “a share of future profits based upon the achievement of certain milestones.” Under the terms of the agreement, Sprout would become a division of Valeant but retain its headquarters in Raleigh, North Carolina. The agreement also called for Cindy Whitehead to continue to lead Sprout as its chief executive officer.

To help win FDA approval for the drug despite the agency’s concerns about some of Addyi’s possible side effects, Sprout pledged to postpone for more than a year all paid advertising on behalf of the drug. However, as noted in an article posted at the website of International Business Times, that pledge does not block Sprout from using other avenues to drum up public interest in the drug. Such avenues include social media and interviews with media outlets and other key influencers. Of this new approach to marketing, Dan Leinweiber, president of the PR firm that bears his name, said, “I think what they’re doing is pretty clever, actually. This is a much less costly way to get their word out in a much more credible way.”

This is just one of a number of articles about Addyi and related topics that have appeared in recent editions of this blog. Click here to see more.

Photo credit: Smile2011

Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.

Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+