After five months since Sprout Pharmaceuticals announced it was awaiting FDA approval for Addyi’s post-menopausal use, it has gained just that on Dec. 15. Addyi can officially be used for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women 65 years and older.
In July, Addyi received the FDA’s Priority Review designation for its implication on post-menopause [1]. As reported by MedEsthetics in August, Addyi originally received FDA approval for pre-menopausal women in 2015, and in 2021, Health Canada expanded its use for postmenopause. Maral Malekzadeh, DO, told the magazine that Addyi works on brain chemistry rather than replacing hormones, making it a potentially effective option for post-menopause women who cannot use or have not responded to estrogen-based treatments [1].
HSDD affects 10% of U.S. women, with the risk of sexual dysfunction being increased by 50%–70% among women with depression. It is defined in the DSM-IV-TR as the recurrent absence of sexual fantasies and desire for sexual activity, which can lead to personal distress or interpersonal difficulties—sometimes worsening depression for women [2].
“So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to,” said Rachel Rubin, MD, urologist and sexual medicine specialist. “Today’s decision finally includes them. It’s a critical acknowledgment that their pleasure, their wellbeing, and their quality of life matter — and that science-backed care should be available to every woman, at every stage of her life.”
HSDD is thought to be caused by an imbalance between excitatory and inhibitory pathways. Dopamine, norepinephrine, testosterone, estrogen and progesterone are excitatory, whereas serotonin, prolactin and opioids are inhibitory of sexual desire and response [2]. Addyi is effective in this condition, often brought on by menopause, because it is shown to help balance neurotransmitters like dopamine, serotonin and norepinephrine to support sexual desire.
Medspa clinicians in the U.S., who prescribe Addyi for low libido in premenopausal women, will now be permitted to prescribe it for postmenopausal women under this recent approval.
“Over the years, we’ve pushed for the science to speak louder than the stigma — and today’s approval shows how far we’ve come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life,” said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals.
References:
1-https://www.medestheticsmag.com/home/article/22948285/medspas-begin-offering-addyi-for-low-libido-as-fda-weighs-postmenopausal-approval
2-https://psychiatryonline.org/doi/10.1176/appi.focus.20200039
