Top 5 things to know about “female Viagra”

FDA’s long-awaited approval of Addyi (flibanserin) to treat hypoactive sexual desire disorder (HSDD) in premenopausal women, is significant for the prescribing community.

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Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

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Here are the top 5 facts pharmacists and prescribers should know about Addyi:

1. Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies, according to FDA. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). The risks include severely low blood pressure (hypotension) and loss of consciousness (syncope). “These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body,” according to an FDA statement. “Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.”

2. Sprout Pharmaceuticals of Raleigh, N.C., plans to charge around $400 per month for Addyi, similar to other sexual dysfunction medications. While the company has declined to estimate sales projections for the medication it is a “stretch to think that this drug will have the impact both medically and commercially that the PDE-5 inhibitors like Pfizer’s Viagra and Lilly’s Cialis had,” wrote John LaMattina, a contributor to Forbes. Addyi must be taken daily, so its annual could be $5,000 per patient. And insurance companies may not provide full or even partial coverage for Addyi, LaMattina pointed out. Anthem has placed Addyi in its third tier, meaning it will cost patients more than they’re charged for generic medications or preferred brand-name treatments, according to BloombergBusiness. An Anthem spokeswoman said that lifestyle drugs are not typically part of the company’s “standard benefit.”

3. Addyi was previously rejected twice by FDA and many doctors are not in favor of it. “Physicians will have to be convinced to prescribe Addyi. That’s not going to be a trivial exercise…The drug’s effect is modest in the majority of people who might take it. But like every drug, it comes with risks, in this case dizziness, low blood pressure, fainting and sleepiness. Drinking alcohol is contraindicated as well. Many physicians will be hesitant to prescribe this drug,” LaMattina wrote.

4. While the drug has been called "the female Viagra," the 2 drugs have far different mechanisms: Viagra increases blood flow to the penis and flibanserin activates sexual impulses in the brain, similar to selective serotonin reuptake inhibitors (SSRIs) such as Prozac.

5. FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) for Addyi because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. “Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber,” according to FDA.

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