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Addyi Approval History

FDA approved: Yes (First approved August 18th, 2015)

Brand name: Addyi

Generic name: flibanserin

Company: Sprout Pharmaceuticals, Inc.

Treatment for: Hypoactive Sexual Desire Disorder

Addyi (flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.

Addyi (flibanserin) 100 mg tablets, developed by Sprout Pharmaceuticals, was FDA-approved on August 18, 2015 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Flibanserin is the first approved medication for HSDD, and is classified as a multifunctional serotonin agonist antagonist (MSAA).

According to the FDA, 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.

Flibanserin has been dubbed the “Female Viagra” and “the little pink pill”; however compared to Viagra, flibanserin has a distinctly different mechanism.

The proposed mechanism of action of flibanserin involves regulation of several brain chemicals that may affect sexual desire, although the exact mechanism is not known. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, as noted in FDA briefing documents. and has action in the central nervous system. The manufacturer states that flibanserin corrects an imbalance of dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (responsible for sexual satiety/inhibition). Flibanserin is not a hormonal drug and does not affect blood flow like the class of drugs approved for men with erectile dysfunction.

Proponents of the drug emphasize the significant unmet need of a libido-enhancing drug for women. The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

Side effects and drug interactions with flibanserin should be well understood by both provider and patient. Addyi is contraindicated for use with alcohol, in patients with liver impairment, and in patients taking moderate-to-strong CYP3A4 inhibitors. Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU), as well as a Black Box Warning. Adverse effect data showed the most common side effects were dizziness, nausea and sleepiness. The risk of fainting, particularly when combined with alcohol, is a major concern. Due to this interaction Addyi will only be available from certified health care professionals and certified pharmacies. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi and pharmacists must counsel on this interaction. The risk of fainting is also increased due to drug interactions with moderate or strong CYP3A4 inhibitors that interfere with the breakdown of Addyi in the body. FDA is requiring the manufacturer to conduct additional post-marketing studies to better define the interaction between flibanserin and alcohol.

Addyi is taken once daily, at bedtime, to help decrease the risk of fainting, sleepiness and sedation. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

Development History and FDA Approval Process for Addyi

See also.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

• Addyi is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as 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.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.

Limitations of Use • Addyi is not indicated for the treatment of HSDD in postmenopausal women or in men. • Addyi is not indicated to enhance sexual performance.

Important Safety Information

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning.

• Use of Addyi and alcohol increases the risk of severe hypotension and syncope; therefore alcohol use is contraindicated. Before prescribing Addyi, assess the likelihood of the patient abstaining from alcohol. Counsel patients prescribed Addyi about the importance of abstaining from alcohol. • Addyi is available only through a restricted program called the Addyi REMS Program. • Severe hypotension and syncope can occur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, Addyi use in these settings is contraindicated.

Addyi is contraindicated:

• With use of alcohol. • With concomitant use with moderate or strong CYP3A4 inhibitors. • In patients with hepatic impairment.

Summary of Warnings and Precautions

• Hypotension and Syncope due to an Interaction with Alcohol. An interaction between Addyi and alcohol increases the risk of severe hypotension and syncope. Alcohol use is contraindicated. Before prescribing Addyi, the healthcare provider should assess the likelihood of the patient abstaining from alcohol use. • Addyi Risk Evaluation and Mitigation Strategy (REMS) Program. Addyi is available only through a restricted program called the Addyi REMS Program, because of the increased risk of severe hypotension and syncope due to an interaction between Addyi and alcohol. The Addyi REMS requires that prescribers are certified by enrolling and completing training; and, pharmacies are certified and will not dispense Addyi unless it is prescribed by a certified prescriber. More information is available at www. AddyiREMS. com. • Hypotension and Syncope with CYP3A4 Inhibitors. Moderate and strong CYP3A4 inhibitors significantly increase Addyi concentrations, which can lead to hypotension and syncope. Concomitant use of Addyi with a moderate or strong CYP3A4 inhibitor is contraindicated. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e. g. ginkgo, resveratrol) or non-prescription drugs (e. g. cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope. • Central Nervous System Depression. Addyi can cause CNS depression (e. g. somnolence, sedation). In five 24-week, randomized, placebo-controlled, double blind trials of premenopausal women with HSDD the incidence of somnolence, sedation or fatigue was 21% and 8% in patients treated with 100 mg of Addyi at bedtime and placebo, respectively. The risk of CNS depression is increased if Addyi is taken during waking hours, or if Addyi is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations.

Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking Addyi and until they know how Addyi affects them. • Hypotension and Syncope with Addyi Alone. The use of Addyi – without other concomitant medications known to cause hypotension or syncope – can cause hypotension and syncope. In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, hypotension was reported in 0.2% and <0.1% of Addyi-treated patients and placebo-treated patients, respectively; syncope was reported in 0.4% and 0.2% of Addyi-treated patients and placebo-treated patients, respectively. The risk of hypotension and syncope is increased if Addyi is taken during waking hours. Consider the benefits of Addyi and the risks of hypotension and syncope in patients with pre-existing conditions that predispose to hypotension. Patients who experience pre-syncope should immediately lie supine and promptly seek medical help if the symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope. • Syncope and Hypotension in Patients with Hepatic Impairment. Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension, syncope, and CNS depression. Therefore, Addyi is contraindicated in patients with hepatic impairment.

Most Common Adverse Reactions • The most common adverse reactions among patients treated with Addyi were dizziness (Addyi 11.4%; Placebo 2.2%), somnolence (Addyi 11.2%; Placebo 2.9%), nausea (Addyi 10.4%; Placebo 3.9%), fatigue (Addyi 9.2%; Placebo 5.5%), insomnia (Addyi 4.9%; Placebo 2.8%) and dry mouth (Addyi 2.4%; Placebo 1.0%).

Summary of Drug Interactions • Addyi is primarily metabolized by CYP3A4 and, to a lesser extent, by CYP2C19. • Addyi is contraindicated in women taking a moderate (e. g. fluconazole) or strong (e. g. ketoconazole) CYP3A4 inhibitor. • Patients using Addyi with combined oral contraceptives or with weak CYP3A4 inhibitors may experience a higher incidence of adverse reactions. • CYP2C19 inhibitors (e. g. proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals) may increase Addyi exposure, which may increase the risk of hypotension, syncope, and CNS depression. • Do not use Addyi with strong CYP3A4 inducers (e. g. rifampin, St. John’s Wort) as this will substantially reduce the concentration of Addyi. • Addyi inhibits P-glycoprotein (P-gp). Monitoring of drug concentrations of any narrow therapeutic index drugs that are substrates for P-gp (e. g. digoxin) should be increased if co-administered with Addyi. The concomitant use of Addyi with digoxin, a drug that is transported by P-gp, increases the digoxin concentration. This may lead to digoxin toxicity.

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Fibanserin tablet

What is this medicine?

FIBANSERIN is used to treat decreased sexual desire in women who have not gone through menopause and who have never had low sexual desire in the past. Flibanserin is for use only when low sexual desire is NOT caused by a medical condition, a mental disorder, relationship problems, or by using drugs or other medicines. Flibanserin is not for women who have already gone through menopause. This medicine is also not for use by men.

What should I tell my health care provider before I take this medicine?

You must not drink alcohol while taking flibanserin. It may cause you to have dangerously low blood pressure.

You should not use flibanserin if you are allergic to it, or if you have:

low blood pressure;

a history of alcoholism or drug addiction;

liver disease;

a history of depression or mental illness; or

if you currently drink alcohol.

Some medicines can cause unwanted or dangerous effects when used with flibanserin. Your doctor may need to change your treatment plan if you use any of the following drugs:

nefazodone;

an antibiotic--ciprofloxacin, clarithromycin, erythromycin, telithromycin;

antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole;

antiviral medicine to treat hepatitis C--boceprevir, telaprevir;

heart or blood pressure medicine--conivaptan, diltiazem, verapamil; or

HIV or AIDS medicine--atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

To make sure flibanserin is safe for you, tell your doctor if you have:

history of alcoholism or drug addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flibanserin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Flibanserin is not approved for use by anyone younger than 18 years old.

How should I use this medicine?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Take flibanserin only at bedtime. Flibanserin can lower your blood pressure, which can make you dizzy. If you feel light-headed after taking this medicine, lie down if you are not already in bed. It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

What if I miss a dose?

Skip the missed dose and take the medicine the following day at bedtime. Do not take flibanserin in the morning, and do not take extra medicine to make up the missed dose.

What may interact with this medicine?

Taking this medicine with other drugs that make you sleepy or lower your blood pressure can worsen this effect. Ask your doctor before taking flibanserin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures. Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with flibanserin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What should I watch for while using this medicine?

Do not drink alcohol while taking flibanserin . Drinking alcohol with this medicine can cause dangerous or unwanted side effects. Grapefruit and grapefruit juice may interact with flibanserin and lead to unwanted side effects. Avoid the use of grapefruit products while taking flibanserin. Avoid taking an herbal supplement containing: ginkgo, resveratrol, or St. John's wort. Flibanserin may impair your thinking or reactions. Avoid driving or operating machinery for at least 6 hours after you take flibanserin, and until you know how this medicine will affect you. Dizziness or low blood pressure can cause falls or other accidents. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What side effects may I notice from this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have:

severe drowsiness; or

a light-headed feeling, like you might pass out.

Common side effects may include:

dizziness, drowsiness;

tiredness;

nausea;

dry mouth; or

sleep problems (insomnia).

Where should I keep my medicine?

Store at room temperature away from moisture and heat.