Addyi (flibanserin) Cost, Side Effects, Dosage, And Prescribing Information For HSDD | Yingqi Zhang, PharmD | RxEconsult
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Addyi (flibanserin) Cost, Side Effects, Dosage, And Prescribing Information For HSDD Category: Women's Health by - September 25, 2015 | Views: 7557 | Likes: 0 | Comment: 0  

Addyi Cost, Side Effects, Dosage

Brand Name: Addyi
Generic Name: flibanserin

Drug class: Mixed serotonin Receptor 1A Agonist and serotonin Receptor 2A antagonist
Similar Drug: None
Manufacturer: Sprout Pharmaceuticals
FDA Approval Date: August 18, 2015

What is Addyi and its mechanism of action?

Addyi (flibanserin) is the first FDA-approved medication to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The exact mechanism of action of Addyi is unknown but it is believed to be associated with serotonin receptors (5-HT1A and 5-HT2A). Both 5-HT1A and 5-HT2A receptors are associated with several functions including anxiety, blood pressure regulation, and sexual desire. Sexual desire is mediated by brain circuits that connect prefrontal cortex (PFC) with limbic and cortical areas. This area of the brain is also known as the rewards processing center. Neurotransmitters such as dopamine and norepinephrine and hormones like testosterone and estrogen are up-regulators in this process. Hypoactive sexual desire disorder is believed to be the result of  inhibition of these neurotransmitters. Addyi modulates serotonin receptors which cause an increase in the release of these neurotransmitters  subsequently enhancing  sexual desire.

What are the uses for Addyi?

Addyi is FDA approved for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). HSDD is characterized as low sexual desire with marked distress or interpersonal difficulty. The lack of desire is not caused by medications, stress within the relationship, or a co-existing medical or psychiatric condition. Addyi is not indicated for the treatment of HSDD in postmenopausal women or in male patients.

How effective is Addyi?

The effectiveness of Addyi was evaluated in three 24-week, randomized, double-blind, placebo-controlled trials involving 2375 patients. The primary end points were evaluated based on monthly satisfying sexual events (SSEs) including sexual intercourse (e.g., oral sex, masturbation, or genital stimulation by the partner) and Female Sexual Function Index (FSFI) Desire Domain Scoring. FSFI is a rating scale with questionnaires that documents  sexual interests. The difference in the percentage of responders between Addyi and placebo is 8-9 % for SSEs (29-39% for Addyi compared to 21-31% for placebo), 10-13% for FSFI desire domain (43-48% for Addyi compared to, 31-38% for placebo).

Interesting facts about Addyi

  • Addyi is not indicated for children or elder patients.
  • Addyi is not used to enhance sexual performance.
  • Addyi should be discontinued after 8 weeks if there is no increase in sexual desire). .
  • Addyi is under a restricted program called Addyi REMs Program due to its side effect profile.
  • Patients with very little or no CYP2C19 enzyme activity (CYP2C19 poor metabolizers) have a higher risk of adverse reactions.

What is the dosage of Addyi?

Addyi is available as a 100 mg oval, film-coated tablet. The dose is one table taken every night at bedtime. 

Next: side Effects, Interactions, Warnings, Cost

 

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