Addyi

Flibanserin

For Hypoactive Sexual Desire Disorder

Track record

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Short (approved in 2015)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Hypoactive Sexual Desire Disorder

What is Hypoactive Sexual Desire Disorder?

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Other treatments for Hypoactive Sexual Desire Disorder

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

Where Addyi fits?

Addyi is the only drug approved to treat premenopausal women who are very bothered by hyposexual desire disorder (HSDD) - low sexual desire not caused by a medical or psychiatric condition, relationship problem or because of side effects from other drugs. Addyi is controversial for a number of reasons. First, some people question whether HSDD is actually a disease: there is no clear definition of what constitutes a normal amount of sexual desire, because so many things can cause low desire. Second, all FDA clinical reviewers voted against approving Addyi because they felt that the small potential benefits of the drug were outweighed by the potential harms including dangerous low blood pressure and fainting (problems made worse with any use of alcohol or many popular prescription and over the counter drugs).

In approving Addyi (over the objection of their own clinical team), FDA acknowledged the limited benefits of the drug and worrisome harms but emphasized that there was a role for the drug for women with HSDD for whom other treatments failed. The FDA Office Director's memo highlighted a number of non-drug approaches to low desire including: psychological interventions including sexual skills training, sex therapy, cognitive-behavioral therapy, marital therapy, systematic desensitization, and education interventions.

Benefit

Addyi increase the number of sexually satisfying encounters: on average, women had about 0.5 more satisfying encounters a month compared to placebo. About 10% more women reported "much" or "very much" improvement" in their distress about low desire. But Addyi did not improve a measure of sexual desire in either of the 2 trials using daily diary scores (the most valid method according to FDA).

Side effects

Addyi has important side effects that were serious enough for FDA to require a "black box" warning - its most serious safety alert - about not drinking alcohol or taking certain medicines or herbal supplements with Addyi because of dangerously low blood pressure and fainting. These problems are so serious that FDA only allowed it to be available through doctors and pharmacists who have undergone special training. Addyi can also cause drowsiness which could affect safe driving especially if it is taken during waking hours or mixed with alcohol or certain medicines or herbal supplements. Other common side effects seen with Addyi include dizziness, sleep problems (trouble falling or staying asleep), nausea, dry mouth and fatigue.

FDA-approved use

To treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is NOT approved to enhance sexual performance.

Hypoactive sexual desire disorder (HSDD) is defined as low sexual desire that causes distress and is NOT due to a medical or mental health problem, problems within the relationship, or medications or other drug use. Addyi is approved to treat low sexual desire in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Who might consider taking it?

Premenopausal women who are very distressed by low sexual desire. Addyi is NOT for women who have gone through menopause, men, or children.

What is not known

Not tested in elderly patients

Track record

SHORT TRACK RECORD

Short track record means that new‚ unexpected side effects may emerge - most likely in the first 3 years after approval. Addyi was approved by FDA in 2015. Clinical trials done before approval generally study a limited number of people for a relatively short time. Important side effects may emerge after Addyi is on the market when larger numbers of people - with other conditions and on other medications - have used the drug. Since Addyi is the first drug approved for HSDD‚ experience is particularly limited.

Open questions

FDA-required studies at approval to answer questions about harms

The drug company was required to conduct additional studies about possible side effects‚ including dangerously low blood pressure, fainting, accidents or injuries, deaths, appendicitis, and harms to women or babies during pregnancy. Because the alcohol studies done prior to approval were done in men rather than premenopausal women (21 of 24 people in the trial were men), FDA is requiring 3 alcohol interaction trials testing how dangerous Addyi is with the “real world” use of alcohol. None of these studies have done been done yet.

Do not take if you...

Drink alcohol

Can increase chance of severe low blood pressure and fainting

Take drugs in the family called "moderate or strong CYP3A4 inhibitors"

Including amprenavir (Agenerase), atazanavir (Reyataz, in Evotaz), boceprevir (Victrelis), ciprofloxacin (Cipro), clarithromycin (Biaxin, in Prevpac), conivaptan (Vaprisol), diltiazem (Cartia XT, Diltzac, Tiazac, others), erythromycin (E.E.S., Ery-Tab, Erythrocin), fluconazole (Diflucan), fosamprenavir (Lexiva), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), nefazodone, nelfinavir (Viracept), posaconazole (Noxafil), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), telaprevir (Incivek), telithromycin (Ketek), verapamil (Calan, Covera, Verelan, in Tarka), and grapefruit juice

Have liver disease

Increases Addyi blood levels which can lead to severe low blood pressure and fainting

Safe if pregnant or breastfeeding?

Pregnant

Unknown if Addyi will harm your unborn baby

Breastfeeding

Do not breastfeed while taking Addyi - either stop breastfeeding or stop Addyi

NEXT: TRIALS

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