Addyi™ (Flibanserin), First-Ever Medical Treatment For Acquired, Generalized HSDD In Premenopausal Women, Now Available

RALEIGH, N.C., Oct. 19, 2015 /PRNewswire/ -- Sprout Pharmaceuticals, Inc. (Sprout), a division of Valeant Pharmaceuticals North America LLC, announced today that Addyi, a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, is now available in the United States through certified physicians and pharmacies.  Addyi was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2015.

"Finally, all women who have been waiting for a medical treatment option can now make their own decision with their healthcare provider if Addyi is right for them," said Sprout Pharmaceuticals Chief Executive Officer Cindy Whitehead. "With our availability nationwide today, we are proud of our affordable and innovative programs to offer Addyi for as little as $20 per prescription."

Sprout will offer two avenues of affordable access for women, including the Addyi Affordable Access Card for pharmacies and the AddyiDirect program with doorstep delivery. For more information about both programs, visit www.Addyi.com or visit your healthcare provider. Addyi is available through certified health care prescribers and pharmacies enrolled in the Addyi Risk Evaluation and Mitigation Strategy (REMS) program. The Addyi REMS certification and enrollment materials can be accessed via www.Addyi.com in the REMS section.

"Acquired, generalized HSDD is the most common sexual complaint that I see among women in my practice, so having Addyi as an option for them is game changing. It's my belief that Addyi marks a new era for women and couples to have an honest conversation about what's happening for her in the bedroom.  I think we'll see the positive effects of this dialogue well beyond medicine," said Dr. Karen Boyle, urologic surgeon at Chesapeake Urology Associates at Greater Baltimore Medical Center.

The approval of Addyi is largely based on three North American, Phase 3, 24-week, randomized double blind, placebo-controlled studies of premenopausal women with HSDD. Addyi was administered to over 2,500 premenopausal women with acquired, generalized HSDD in clinical trials, with over 850 receiving treatment for at least 12 months. For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.

Addyi is not indicated for use in postmenopausal women or men or to enhance sexual function. Addyi was approved with a Boxed Warning. Use of Addyi with alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated.  Severe hypotension and syncope occurs when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore use of Addyi in patients with hepatic impairment is also contraindicated. Hypotension, syncope and central nervous system (CNS) depression can occur with Addyi alone. The most common adverse reactions are dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. See full safety information below. Addyi is intended to be administered orally once per day at bedtime with or without food.

About Hypoactive Sexual Desire Disorder (HSDD) 
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. 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.

About Sprout Pharmaceuticals 
Sprout Pharmaceuticals is passionate about women's sexual health. With a breakthrough concept for women, the company "sprouted" out of Slate Pharmaceuticals in 2011. Based in Raleigh, N.C., the company is focused solely on the delivery of a treatment option for women with Hypoactive Sexual Desire Disorder (HSDD). For more information or the latest news about Sprout Pharmaceuticals, visit www.sproutpharma.com or call 1-844-PINK-PILL (1-844-746-5745).

Indication and Important Safety Information

Indication

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

Contraindications

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.

For More Information: 
Amy Rose
Edelman
312-297-6912
[email protected]

SOURCE Sprout Pharmaceuticals

Related Links

http://www.sproutpharma.com