FDA Approves First Treatment Pill for Decreased Libido in Women -- With Restrictions

The U.S. Food and Drug Administration, FDA, on Tuesday approved the so-called "little pink pill" marketed as Addyi to treat acquired, generalized hypoactive sexual desire disorder (HSDD). In simpler words, the controversial drug is intended to boost decreasing sex drive in women.

Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women. Thus, Flibanserin (Addyi) becomes the first FDA-approved drug designed to help women with low libido.

Important restrictions and warnings

This approval, however, comes with significant restrictions because the FDA warns that, "Addyi can cause 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."

Beware low BP, loss of consciousness!
Not recommended for use with alcohol

Therefore, Addyi's label will include a boxed warning saying the drug shouldn't be taken while drinking alcohol, and shouldn't be used with certain other drugs and by women with liver problems.

Also, the once-daily pill, to be taken at night, can only be prescribed or dispensed by doctors and pharmacists who have been thoroughly briefed on the drug and its benefits and risks.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

HSDD, the disorder and Addyi, the drug

Hypoactive sexual desire disorder (aka HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

Also see: What is hypoactive sexual desire disorder (HSDD)?

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and the related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

Addyi will be marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

Cindy Whitehead, Sprout's chief executive, said the retail price of Addyi had not been decided. But she added that it would probably be comparable to the monthly cost of erectile dysfunction pills such as Viagra and Cialis, The New York Times reported.

Drug proponents vs opponents

The pursuit of a drug for women with low libido has been like a Holy Grail for the pharmaceutical industry, given the enormous popularity and financial windfall from the erectile dysfunction drugs Viagra and Cialis for men since the late 1990s.

And Addyi's long road to FDA approval -- it had been rejected twice by the agency since 2010 -- was a contested affair.

Dr. Holly Thacker, a women's health specialist at the Cleveland Clinic, said the FDA's approval of Addyi "provides an additional, helpful option for women across the country who experience sexual dysfunction. It doesn't treat all sexual dysfunction, it won't help all women with sexual problems, but it will have a role in the therapy."

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City, said: "Although the efficacy [effectiveness] of flibanserin is not clear, it seems to be safe. Couples will have the option of finding out for themselves whether or not it enhances their sexual relationship. It is clear that flibanserin will not address interpersonal or emotional problems. Nor will it address issues related to painful intercourse."

Proponents said the drug would provide an important option for millions of American women who suffer from hypoactive sexual desire disorder, which causes a persistent or recurring lack of desire.

But opponents cite a host of concerns about the drug. Among the concerns: symptoms of extreme fatigue and the potential for accidental injuries, as well as questions about the medication's effectiveness.

One in five women in clinical trials reported that the drug caused feelings of extreme fatigue and sedation. Accidental injuries associated with this fatigue occurred twice as often in women taking flibanserin compared with those taking a placebo, FDA documents showed.

An FDA advisory panel voted 18 to 6 in June to recommend the drug's approval, but the endorsement was somewhat muted. The committee called the drug's benefits "moderate" or "marginal," and the panel members who voted yes said full FDA approval should come with conditions.

One of flibanserin's detractors is psychotherapist Keesha Ewers, founder and chief medical officer of the Functional Sexology Institute, who contends the drug hasn't been shown to be very effective.

Women in clinical trials for the drug reported, at best, an increase of one additional satisfying sexual event per month, according to FDA documents. Plus, clinical trials have also shown that the drug doesn't appear to directly boost a woman's libido, Ewers said.

"Not one person in the studies that have been done has actually reported an increase in sexual desire," she told HealthDay. "What has been reported is a decrease in the distress that is felt about lack of sexual desire."

Other issues

Although there were some safety concerns about flibanserin (extreme fatigue, sedation and accidental injuries), its backers mounted a marketing campaign called "Even the Score," which used a gender-rights argument to advocate for the drug's approval. The campaign received funding from Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals, all of which are working on drugs to treat female sexual disorders.

A number of high-profile groups such as the National Organization of Women signed onto the campaign, arguing that women deserve a medication that helps sexual function since men already have Viagra and Cialis.

Other groups in support of Even the Score include the American Sexual Health Association, the Association of Reproductive Health Professionals, the National Association of Clinical Nurse Specialists, the Society for Women's Health Research, and the Institute for Sexual Medicine.

Ewers said it's a false argument to compare flibanserin for women to Viagra or Cialis for men. Viagra works on a man's body, stimulating blood flow to create easy erections. "That's an actual physiological function -- erection," she said. "It's not affecting their desire. It's affecting their plumbing."

References:
1). U.S Food and Drug Administration: FDA approves first treatment for sexual desire disorder. Downloaded on 19th August 2015 at 6:20pm WAT. Available online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm.
2). MedlinePlus: FDA Approves Libido Pill for Women -- With Restrictions. Downloaded on 19th August 2015 at 6:52pm WAT. Available online at https://www.nlm.nih.gov/medlineplus/news/fullstory_154158.html.