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Are the Expectations for Female Viagra Realistic?

Many women are troubled by a loss of sexual desire and hope that Addyi may be able to fire up their libidos.

Many women are troubled by a loss of sexual desire and hope that Addyi may be able to fire up their libidos.

After a long and often torturous path to approval, a prescription drug to treat abnormally low sexual desire in women will soon be brought to market. That drug, flibanserin, is expected to be sold under the brand name Addyi by a division of Valeant, the Canadian-based pharmaceuticals giant. Valeant announced its plan to acquire Sprout Pharmaceuticals, flibanserin’s patent-holder, two days after the FDA gave the drug its thumbs-up, albeit with some conditions attached.

While a large number of women’s health organizations passionately campaigned for FDA approval of this drug, not all women or medical professionals are in favor of the drug. In fact, many remain unconvinced that the drug will make a dent in the problem of hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction.

First Drug of Its Kind

Flibanserin is the first FDA-approved drug for the treatment of female sexual dysfunction, but few of its proponents would argue that it’s likely to have as revolutionary an effect on female sexual dyfunction as Viagra did on erectile dysfunction, one of the most common forms of male sexual dysfunction.

Although headline-writers and others have taken to calling flibanserin “female Viagra” or “pink Viagra,” it has very little in common with the little blue pill that helps men overcome erection problems. Male sexual dysfunction can most often be traced to insufficient blood flow to the penis, but women’s sexual problems are usually linked to imbalances in brain chemistry. And trying to rebalance neurotransmitters such as dopamine, norepinephrine, and serotonin is much more daunting a challenge than increasing blood flow.

Differ in Degree of Effectiveness

In addition to the fundamental differences in how Addyi and Viagra act, there are also significant differences in the degree of efficacy these drugs have shown in test studies. While Viagra and other PDE5 inhibitors, such as Levitra and Cialis, have been shown to be safe and effective in more than 50 percent of healthy men, Addyi came nowhere this level of effectiveness in studies conducted prior to the drug’s approval.

The Food and Drug Administration on August 18, 2015, gave its conditional approval to Addyi, a drug designed to treat the most common form of female sexual dysfunction.

The Food and Drug Administration on August 18, 2015, gave its conditional approval to Addyi, a drug designed to treat the most common form of female sexual dysfunction.

For a study designed to determine both the efficacy and safety of flibanserin, researchers assembled a study group of nearly 1,100 premenopausal North American women, all of whom had been diagnosed with HSDD. The mean age of study participants was 36.6 years. Researchers divided the test subjects into two groups of roughly equal size. The first group, numbering 542 women, got a daily dose of 100 milligrams of flibanserin at bedtime, while the second group, made up of 545 women, got a placebo instead. The study period covered 24 weeks.

Results of Study

At the end of the study, those receiving the nightly dose of 100 milligrams of flibanserin showed a mean increase in sexually satisfying events, or SSE, to 2.5 vs. 1.5 for those who got placebo. Those getting flibanserin also reported mean Female Sexual Function Index (FSFI) desire scores of 1.0, compared with mean scores of 0.7 for those on placebo. The most widely reported adverse side effects were drowsiness, dizziness, and nausea. These unpleasant side effects caused a dropout rate of 9.6 percent among those who got flibanserin, compared with 3.7 percent among those on placebo.

In their conclusion to the flibanserin study, published in the July 2013 issue of “The Journal of Sexual Medicine,” researchers said that the once-daily dose of 100 milligrams of flibanserin “resulted in significant improvements in the number of SSE and sexual desire vs. placebo.”

Drug May Not Work for All

An article posted by Natalie Morrison at Forbes.com, points out that just 7 percent of premenopausal women in the United States are believed to have HSDD. Moreover, the article notes that doctors don’t expect that Addyi will be effective in ridding all those women of their symptoms.

Further barriers to the drug’s widespread use in the United States include the conditions that have been attached by the FDA in handing down its approval. Addyi was approved under the agency’s Risk Evaluation and Mitigation Strategy (REMS) program, which requires that doctors and pharmacists be trained and certified in REMS before they can prescribe or provide the drug to patients.

Women have fought for a drug to combat decreased sexual desire, which can sabotage otherwise loving relationships.

Women have fought for a drug to combat decreased sexual desire, which can sabotage otherwise loving relationships.

On top of that, FDA’s approval of the drug is contingent on the inclusion of a boxed warning in the drug’s packaging insert, alerting users to the drug’s possible severe side effects, including low blood pressure and syncope (fainting), especially when used with alcohol.

Price Could Be a Barrier

Yet another potential barrier to strong sales for Addyi could be price and insurers’ refusal to reimburse their policyholders for the drug. No price for Addyi has been announced, but Sprout CEO Cindy Whitehead told The New York Times that it will be comparable with the price of Viagra and other impotence drugs. Because Viagra is taken on an as-needed basis, unlike Addyi, which must be taken daily to be effective, Whitehead’s comment does little to clarify what the drug’s price will be. And how insurers will treat the drug, given its relatively modest benefits, remains to be seen.

On the plus side, Valeant’s quick move to buy up Sprout must be read as a significant vote of confidence. Whether that confidence turns out to be justified or not, only time will tell. However, in his announcement of the acquisition plan, Valeant CEO J. Michael Pearson strongly suggested that Addyi will be the first in a new product line for the Canadian-based drugmaker. Pearson said, “Delivering a first-ever treatment for a commonly reported form of female sexual dysfunction gives us the perfect opportunity to establish a new portfolio of important medications that uniquely impact women.”

Pessimistic Prediction

In yet another article posted at Forbes.com, John LaMattina, former president of Pfizer Global Research and Development, expresses doubt that Addyi will come anywhere close to having the same impact on female sexual dysfunction that Viagra and Cialis have had on male sexual dysfunction. LaMattina suggests there will be an initial surge of demand for Addyi, followed by a period of reflection during which most women may well decide “that Addyi’s limited efficacy isn’t worth the expense and safety issues.”

One of flibanserin’s most outspoken critics has been psychologist Leonore Tiefer, Ph.D., an associate professor of psychiatry at New York University School of Medicine. Tiefer has been a longtime crusader against the increasing medicalization of male and female sexuality, arguing that not all sexual problems can be solved simply by popping a pill.

In the wake of Addyi’s approval by the FDA, Tiefer told a reporter for the Huffington Post that the slow-acting nature of the drug may discourage users looking for a quick fix. “This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all.”

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+