FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

In the alcohol-interaction study, some participants had hypotension or syncope requiring intervention,

Before using flibanserin

Boehringer Ingelheim, the original applicant, completed a new phase 3 trial with the primary end points of satisfying sexual events and sexual desire as assessed by the FSFI; a secondary end point was reduction of distress related to low sexual desire. All three were achieved, and results were consistent with previous findings. However, treatment effects in all three phase 3 trials were small (see Table 1). Major safety concerns regarding flibanserin include risks of hypotension, syncope, and central nervous system (CNS) depression (e.g., somnolence). These risks increase when the drug is taken during the day, with concomitant use of any of the numerous moderate or strong cytochrome P-450 3A4 (CYP3A4) inhibitors such as some of the antiretroviral drugs, antihypertensive drugs, antibiotics, and fluconazole (which increase systemic exposure to flibanserin by a factor of 4.5 to 7), and with alcohol use. such as being placed supine or in Trendelenburg position, when they took

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flibanserin with the equivalent of as little as two alcoholic drinks for

Property	Description	Status
Approved Uses	Hypoactive Sexual Desire Disorder (HSDD) in women	Yes
Mechanism of Action	Serotonin receptor modulator	Partial agonist & antagonist
FDA Approval Year	2015
Common Brand Name	Addyi

someone weighing 70 kg (e.g., two 5-oz glasses of wine containing 12% alcohol).

• Flibanserin acts as an agonist on dopamine receptors and antagonist on certain serotonin receptors.
• The medication can take several weeks to show benefits.
• It is not approved for use in postmenopausal women.
• Flibanserin was initially developed as an antidepressant.
• It has a pharmacokinetic profile with a half-life of around 13 hours.
• Dose adjustments are necessary for patients with liver impairment.
• The drug can cause hypotension, especially with alcohol or CYP3A4 inhibitors.
• Patients are monitored for side effects such as sleepiness and low blood pressure.
• Flibanserin's efficacy is moderate and varies among women.

These participants had systolic and diastolic blood-pressure reductions of 28 to 54 mm Hg and 24 to 46 mm Hg, respectively.

Real Science. Real Results.

Take certain medications that interact with Addyi (flibanserin) and put you at risk for low blood pressure and fainting N Engl J Med 2016;374:101-104 Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice. HSDD is characterized by reduced sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty and is not accounted for by coexisting conditions, use of medications, or relationship problems. At a 2014 meeting, the FDA heard from some women about the condition's effects on their sense of identity, emotional well-being, and relationships.1 Although nonpharmacologic approaches to HSDD are important, we recognized that some women could benefit from drug therapy. Such treatments must meet the statutory standard for demonstration of effectiveness (substantial evidence from adequate, well-controlled trials) and have favorable benefit–risk profiles.

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Assessing flibanserin has proven challenging; the drug has been reviewed three times by the FDA and discussed twice at public advisory committee meetings. The first advisory committee, convened in 2010, unanimously recommended against approval.2 In the two phase 3 trials, one primary end point, satisfying sexual events, was achieved, but the other, daily sexual desire, was not. Although the trials showed an effect on sexual desire over the previous 4 weeks as recalled by participants — assessed with the Female Sexual Function Index (FSFI) — the committee believed that an effect on daily recall of sexual desire was preferable and thought that results on the FSFI, a secondary end point, should not override the failure to achieve a primary end point. The committee also expressed concern about adverse effects such as somnolence and drug interactions. The FDA rejected the application and requested additional studies, including a new phase 3 trial, an alcohol-interaction study, and drug–drug interaction studies. The study did not definitively delineate the risk in premenopausal women who take flibanserin at bedtime because 23 of

• Flibanserin's development was rooted in attempts to find antidepressants with sexual side effects.
• It was repurposed as a treatment for female sexual desire disorder.
• The medication is available by prescription only.
• It belongs to the class of serotonergic drugs affecting brain chemistry.
• Women with liver disease should avoid taking flibanserin.
• The medication is primarily metabolized in the liver via CYP3A4.
• Flibanserin has been the subject of debates over its cost-benefit ratio.
• It is not approved for use in men or non-binary individuals.
• Clinical guidelines recommend using flibanserin only after other causes of low desire are addressed.

the 25 participants were men, flibanserin was administered in

• Flibanserin was developed by Boehringer Ingelheim, later licensed to Sprout Pharmaceuticals.
• It is considered a "female Viagra," though its mechanism differs from male erectile drugs.
• The medication is part of the growing field of female sexual dysfunction treatment.
• Most clinical trials showed a modest increase in satisfying sexual events.
• Flibanserin should be taken consistently for best results.
• It is not recommended for women who are pregnant or breastfeeding.
• Common adverse reactions include dry mouth and insomnia.
• The drug was approved after extensive clinical trials involving thousands of women.
• Long-term safety data is still being collected.

the morning, and alcohol was consumed rapidly (within 10 minutes).

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The percentages might be a little different for postmenopausal women. Contact your healthcare provider immediately if you experience any of the following. Allergic reaction: swelling of the face, lips, or mouth; itchiness; hives; trouble breathing Side effects that you should report to your care team as soon as possible: Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): One of the few FDA-approved medications for low sex drive in women under 65 Has limitations for drinking alcohol during treatment Not for low sex drive caused by a medical or mental health condition, relationship problem, or side effect from medications Most Addyi (flibanserin) side effects, like dizziness, tiredness, and feeling faint, typically start to happen within the first 2 weeks after you start treatment. Lie down if you feel dizzy right after you take the medication. Call your prescriber if these side effects don't go away.

Biochem/physiol Actions

Take Addyi (flibanserin) at bedtime to lower your risk of sleepiness, dizziness, lightheadedness, and accidentally hurting yourself from these side effects. Addyi (flibanserin) can make you sleepy and have trouble thinking clearly. Avoid driving a car or doing any activities that need your focus until at least 6 hours after you take Addyi (flibanserin) and until you know how the medication affects you. Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before you take Addyi (flibanserin). And skip your dose in the evening if you've had 3 or more alcoholic drinks.

Interactions with Medicines

Don't drink any alcohol after you take Addyi (flibanserin); wait until the next day. Taking Addyi (flibanserin) and drinking alcohol too close together can put you at greater risk for low blood pressure and fainting. Avoid eating grapefruit or drinking grapefruit juice at any time while you're taking Addyi (flibanserin). Grapefruit can raise your risk of side effects while you're taking this medication. Tell your care team and pharmacist about all the medications, supplements, or foods you take or planning to take. In the phase 3 trials, in which alcohol consumption was not restricted and flibanserin was

Enhancing Healthcare Team Outcomes

Certain medications, herbal supplements, and foods can raise your risk of side effects, such as sleepiness, low blood pressure, and fainting, while you're taking Addyi (flibanserin). If you miss a dose of Addyi (flibanserin) at bedtime, wait until the next night to take your next dose. Don't double up on doses to make up for a missed dose because this can raise your risk for side effects. Addyi (flibanserin) can cause some serious health issues. This risk may be even higher for certain groups.

How is this drug best taken?

If this worries you, talk to your doctor or pharmacist about other options. Taking Addyi (flibanserin) and drinking alcohol too close together can put you at risk for dangerously low blood pressure, dizziness, and fainting. To prevent accidental injury from these side effects, wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before you take Addyi (flibanserin) at bedtime. Skip your dose for the night if you've had 3 or more alcoholic drinks. Don't drink any alcohol after you take Addyi (flibanserin) until the next day.

Breast Feeding

Risk factors: Taking medications, herbal supplements, or foods that interact with Addyi (flibanserin) Addyi (flibanserin) can interact with certain medications, herbal supplements, and foods. These interactions can make your blood pressure drop to dangerous levels and lead to fainting. Some common medications and foods that cenforce d 160 interact with Addyi (flibanserin) include ciprofloxacin (Cipro), fluconazole (Diflucan), birth control pills, and grapefruit. Ask your prescriber or pharmacist for a complete list of medications, supplements, and foods to avoid. Tell your care team all the other medications and herbal supplements you're taking. taken at bedtime, the incidence of syncope was 0.4% with flibanserin and 0.2% with placebo.

• Flibanserin's prescribing information highlights the risk of severe hypotension.
• The drug’s efficacy is evaluated via sexual desire and satisfaction questionnaires.
• It is meant to be part of a comprehensive approach to female sexual dysfunction.
• Some women report improved libido and satisfaction after consistent use.
• Flibanserin can impair alertness, affecting daily activities.
• Medical professionals should counsel patients thoroughly before initiating therapy.
• The medication is not recommended in women with certain pre-existing health conditions.
• Insurance approval may require documentation of HSDD diagnosis.
• Long-term use data for flibanserin is limited, and ongoing studies are necessary.

Although these data appear more reassuring, the extent of alcohol use during these trials was not recorded.

Overdose/Missed Dose

They can help make sure Addyi (flibanserin) is safe for you to take. Follow any directions they give you if you need to switch or stop medications to lower the risk of dangerous drug interactions. Addyi (flibanserin) can cause dangerously low blood pressure and lead to fainting in people with liver problems. Because of this risk, people with liver problems can't take this medication. If you have liver problems, tell your prescriber before you start taking Addyi (flibanserin).

Activity profile

Risk factors: Taking Addyi (flibanserin) during the day Drinking alcohol Taking other medications that can cause sleepiness Taking medications, supplements, or foods that interact with Addyi (flibanserin) Addyi (flibanserin) can make you feel sleepy, tired, and less alert. These side effects can affect your ability to think and focus well. Your risk is higher if you take Addyi (flibanserin) during the day, with alcohol, or with other medications that have similar side effects. Take Addyi (flibanserin) only at bedtime to prevent these side effects. Also avoid driving a car or doing other activities that need your attention until at least 6 hours after you take Addyi (flibanserin) and until you know how the medication affects you.

Concomitant Strong or Moderate CYP3A4 Inhibitor Use

It's possible to have an allergic reaction to Addyi (flibanserin). Stop taking the medication and call for medical help right away if you notice any swelling of your face, lips, or mouth; itchiness; hives; or trouble breathing. The typical dose is 100 mg by mouth once a day at bedtime. Contraindications are specific health conditions or situations in which a person should not take a medication due blue pillmen to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Addyi (flibanserin) will not be safe for you to take.