Widely touted as the long-awaited answer to demands for a medication to reinvigorate Female Sexual Desire, Addyi has thus far proved to be a major disappointment. After a hard-fought battle for Food and Drug Administration approval, the prescription medication first went on sale in the United States in October 2015. More than 18 months later, sales have been significantly lower than were forecast in the days immediately following FDA approval.

There is no single reason for Addyi’s disappointing sales performance but rather a number of factors that collectively have discouraged prospective customers from signing on to the Addyi treatment plan. These factors include:

1. Positive Effects of Drug Are Not All That Impressive

Addyi (flibanserin is its active ingredient) doesn’t improve female sexual desire by a significant degree. Clinical tests conducted in pursuit of FDA approval and subsequently indicate that women taking Addyi experienced on average only one-half to one additional satisfying sexual event per month as a result.

2. Addyi Must Be Taken Daily

To produce even these minimal increases in sexual desire, Addyi must be taken daily. This is in sharp contrast to the drugs designed to treat erectile dysfunction, one of the most serious forms of male sexual dysfunction. Those drugs, including Viagra, Cialis, Levitra, and others, can be taken as needed, 15 to 60 minutes before the beginning of sexual activity. Many women are unwilling to obligate themselves to a drug that must be taken daily.

3. Black Box Warning Cautions of Side Effects

Concerned by test data showing that some study participants experienced extreme dizziness and even brief loss of consciousness while taking Addyi, the FDA required that packaging materials for the drug carry a black box warning about these side effects.

4. Drug Is Incompatible with Alcohol

A woman who has decided to take Addyi must swear off alcohol use for as long as she is taking the drug. Clinical trials showed that concurrent use of alcohol and Addyi significantly exacerbates the side effects of the drug.

5. Prescribing Doctors Must Be Certified

To ensure that prospective users of the drug are fully aware of its potential side effects and dangers, the FDA requires that doctors who seek to prescribe Addyi must first complete an online training course in order to be certified. The same requirement is imposed on pharmacists who seek to dispense the drug. Once certified, physicians and pharmacists presumably know enough about Addyi to knowledgeably counsel their patients and customers.

6. Drug Is Relatively Costly 

At the time this article was written, the average cash price for 30 100-milligram tablets of Addyi — a month’s supply — ranged from $825 to $950, according to GoodRX.com.

7. Few Insurers Cover the Drug

Because of the drug’s high costs, health insurers have been reluctant to reimburse for it. Among those who do, some insurers require that their insureds first visit a psychiatrist to determine whether, in fact, they suffer from hypoactive sexual desire disorder, a diagnosis that is difficult to make.

8. Female Sexuality Is Complex

Although Addyi is frequently referred to as “female Viagra” or “pink Viagra,” these nicknames are very misleading, because the female drug works in an altogether different fashion than the male ED drugs. Female sexuality is much less straightforward than male sexuality. For most men, ED is caused by insufficient blood flow to the penis, which can be treated by drugs, devices, and procedures that improve — at least temporarily — that blood flow. The control center for female sexual desire is the brain, an organ that is much more complex and challenging to treat than the male vascular system.

Flibanserin followed a slow and somewhat tortuous path to FDA approval. It was first developed as an antidepressant by German drugmaker Boehringer Ingelheim. Recognizing its potential as a possible treatment for abnormally low female sexual desire, Boehringer in 2009 filed a new drug application (NDA) with the FDA seeking to market the drug for that purpose. In June 2010 an FDA advisory panel unanimously recommended that the drug regulatory agency reject the NDA.

Boehringer Abandons Flibanserin

Four months later, Boehringer announced that it was abandoning its efforts to win FDA approval for flibanserin. Early the following year, Sprout Pharmaceuticals, a small North Carolina company, purchased the rights to flibanserin and announced its intention to pursue FDA approval so that the drug could be brought to market.

In June 2013, Sprout submitted a revised NDA for flibanserin. An FDA advisory panel again recommended against FDA approval of the drug, a decision that Sprout promptly appealed. As a result of the appeal, Sprout received from the FDA recommendations about additional studies it could conduct that might persuade the agency to give flibanserin the green light.

Third Time’s a Charm

After conducting the recommended clinical trials, Sprout resubmitted its flibanserin application in February 2015. This time, the advisory panel voted 18-6 to recommend full agency approval of the drug, which it did on August 18, 2015. Two months later, Addyi made its official debut on the U.S. market.

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