Vyleesi vs Addyi: the two approved HSDD drugs
Every row cites its source. Where a cell reflects our own reading of the evidence rather than an external source, the row says so.
| Aspect | Vyleesi (bremelanotide) | Addyi (flibanserin) | Source |
|---|---|---|---|
| Mechanism and class | Melanocortin receptor agonist (MC1R/MC4R most relevant); peptide autoinjector | Multifunctional serotonin agonist/antagonist; oral small molecule | source |
| Approval | June 21, 2019 (NDA 210557) | August 18, 2015 (NDA 022526) | source |
| Labeled population | Premenopausal women with acquired, generalized HSDD | Women under 65 with acquired, generalized HSDD | source |
| Regimen | 1.75 mg SC as needed, 45+ min before activity; max 1/24 h, 8/month | 100 mg orally every night at bedtime | source |
| Measured efficacy | Desire +0.35 vs placebo (integrated, scale 1.2 to 6.0); distress -0.33; satisfying sexual events unchanged | Meta-analysis: +0.49 satisfying sexual events/month; FSFI-desire +0.27; evidence quality graded very low | source |
| Defining safety issue | Nausea 40%; transient BP rise each dose; focal hyperpigmentation risk | Boxed warning: hypotension/syncope with alcohol, CYP3A4 inhibitors, hepatic impairment; dizziness RR 4.0, somnolence RR 4.0 | source |
| Key contraindications | Uncontrolled hypertension; known cardiovascular disease | Moderate/strong CYP3A4 inhibitors; hepatic impairment | source |
| Alcohol | No boxed warning; dedicated study at 2.5x exposure found no PK interaction and no excess orthostatic events | Boxed warning; wait 2+ hours after 1-2 drinks, skip dose after 3+ | source |
| Stop rule | Discontinue after 8 weeks without improvement | Discontinue after 8 weeks without improvement | source |
The only two FDA-approved drugs for hypoactive sexual desire disorder, never tested against each other. One is an on-demand injection with a nausea problem and cardiovascular guardrails; the other is a nightly pill with a boxed warning built around alcohol, drug interactions and liver disease. Neither moves the needle far; the honest comparison is between two small, different trade-offs.
No head-to-head trial exists; every row above compares each drug against its own placebo program, which is a weaker comparison than it looks. Efficacy magnitudes come from different instruments and eras and cannot be subtracted from each other.