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ConexiantFDA OKs Addyi for Postmenopausal Women

FDA approved flibanserin (Addyi) for treating frustrating low sexual desire in postmenopausal women under 65—the first approval of its kind for this population. An estimated 40% of women experience hypoactive sexual desire disorder (HSDD), the most common female sexual dysfunction, with postmenopausal women previously having no FDA-approved treatment options.


⚖️ PROFESSIONAL IMPACT

  • FDA granted Priority Review designation, signaling agency recognition of HSDD as serious unmet medical need in postmenopausal population
  • Approval based on largest clinical trials ever conducted in women’s sexual health, with safety/efficacy profile established since 2015 premenopausal approval
  • Health Canada approved expanded use in 2021, providing international precedent for postmenopausal treatment safety and efficacy
  • Treatment prescribed by more than 30,000 US healthcare professionals, suggesting established clinical familiarity despite previous age limitation

🎯 ACTION ITEMS

  • Screen postmenopausal patients under 65 for HSDD using validated assessment tools during routine wellness visits
  • Counsel patients on absolute alcohol restrictions: no alcohol within 2 hours of dosing; skip dose if 3+ drinks consumed
  • Review contraindicated medications before prescribing, particularly HIV antiretrovirals, azole antifungals, and certain cardiovascular agents
  • Document that liver disease is absolute contraindication and assess hepatic function before initiating therapy

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