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What is ADDYI (add-ee) (flibanserin) Tablets?ADDYI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:
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Addyi (flibanserin) is a multifunctional serotonin agonist and antagonist (MSAA) designed to improve sexual arousal and function in premenopausal women who are suffering from reduced sexual desire and interest. This is common among aging women because their hormones shift.
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In each analysis, there was a statistically significant association of weight change at week 24 with baseline body weight and treatment group such that higher baseline body weight and treatment with flibanserin (vs. placebo) were associated with greater weight loss.
The patients with HSDD who participated in these clinical trials of flibanserin were not selected for overweight or obesity, nor did they enter the studies with the goal of losing weight. In the patients with HSDD included in this analysis, baseline BMI ranged from underweight to obese, with rates of overweight (premenopausal women, 27.2%; postmenopausal women, 34.4%) and obesity (premenopausal women, 24.9%; postmenopausal women, 28.2%) somewhat lower than currently observed in the general population of adult women in the United States,25 which may represent a healthy user type bias in these clinical trials. Nonetheless, comparing these findings with studies of FDA-approved weight-loss drugs may provide some context regarding the magnitude of weight loss observed.
The mechanism(s) of action by which flibanserin produces weight loss are currently unknown. The receptor binding affinity of flibanserin is highest for 5-HT1A receptors (as an agonist) and 5-HT2A receptors (as an antagonist).6 Both 5-HT1A agonist activity and 5-HT2A antagonist activity result in the inhibition of glutamate neurons, thereby reducing serotonin release in the prefrontal cortex.6
The complex role of serotonin in mammalian energy balance has not been completely elucidated at this time.32 Based on evidence from numerous studies of the serotonin system, it is generally understood that enhanced serotonergic neurotransmission is associated with suppression of food intake and reduction in body weight.19,26,32 However, mirtazapine, an atypical antidepressant with agonist effects at the 5-HT1A receptor and antagonist effects at the 5-HT2A receptor (similar to flibanserin), is generally known to cause weight gain.33,34 Furthermore, flibanserin is a minor 5-HT2C receptor antagonist,1 yet the 5-HT2C receptor agonist lorcaserin has been approved as a weight-loss drug.22 Thus, the serotonin-related activity of flibanserin does not appear to explain the observed weight loss in this analysis of patients treated with flibanserin.32
Addyi is the trade name for flibanserin, a new non-hormonal prescription medication for hypoactive sexual desire disorder (HSDD) in women. Addyi/flibanserin is the first medicine ever specifically approved to treat loss of sexual desire in either men or women.
The maximum time flibanserin has been studied in premenopausal women is 18 months, and it appears to keep working over that timespan without losing its effectiveness. But more research is going to be necessary before we can say how enduring the effects might be after stopping the drug.
There are some important medical contraindications. For instance, a woman taking Addyi should avoid using alcohol, and should avoid certain medications such as fluconazole (Diflucan and others) that can increase blood levels of flibanserin.
But some women in perfectly happy relationships experience a serious loss of desire following a life event such as the birth of a child, and desire never returns. In that kind of situation, a biological treatment such as flibanserin may make more sense.
Flibansetrin has high affinity for serotonin receptors in the brain: it acts as an agonist on 5-HT1A and an antagonist on 5-HT2A. In vivo, flibanserin binds equally to 5-HT1A and 5-HT2A receptors. However, under higher levels of brain 5-HT (i.e., under stress), flibanserin may occupy 5-HT2A receptors in higher proportion than 5-HT(1A) receptors. It may also moderately antagonize D4 (dopamine) receptors and 5-HT2B and 5-HTB2C. Its action on neurotransmitter receptors may contribute to reduction in serotonin levels and increase in dopamine and norepinephrine levels, all of which may play part in reward processing.
Metabolism is primarily via CYP3A4, slightly CYP2C19. Minimal involvement of CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2D6. At least 35 metabolites of flibanserin are produced, 2 of which reach plasma concentrations as high as parent drug, however they are pharmacologically inactive.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counselling patients about Addyi's risks. Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.
"Women deserve equal treatment when it comes to sex," the group states in an online petition to the FDA, which attracted more than 60,000 supporters. Women's groups, including the National Organization for Women, signed on to the effort, though it was funded by Sprout and other companies working on female sex drugs.
Boehringer developed the drug, flibanserin, as an antidepressant, but it failed to lift depression. The company says it learned serendipitously that the pill, taken daily for weeks, could restore female libido.
In one course, released online in May, a quiz asked doctors to diagnose the condition of a 42-year-old working mother who takes care of three children and her own sick mother, and who had no desire for sex. (Her husband is mentioned only in passing.) 041b061a72