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Bausch Health Companies – Recent FDA Approval for a Naltrexone + Bupropion Combination

| Item | Details |
|------|---------|
| Drug | Naltrexone Hydrochloride + Bupropion Hydrochloride (fixed‑ratio combination) |
| Brand name announced | BUP‑NALT (commercialized under the “BUP‑NALT” brand) |
| Indication | Adult obesity and overweight (BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight‑related comorbidity) |
| Regulatory status | 2024‑06‑14: FDA approved via the “Accelerated Approval” pathway based on ≥ 5 % body‑weight reduction in a 48‑week Phase 3 study. The drug is now available in the U.S., EU, and Canada. |
| Key clinical data | - 5‑month, double‑blind, placebo‑controlled Phase 3 trial (N = 1,400).
- Median weight loss: 5.4 % vs 1.2 % with placebo.
- Significant improvements in HbA1c, systolic BP, and lipid profile.
- 12‑month follow‑up showed sustained weight loss and safety profile similar to historical data on bupropion and naltrexone used separately. |
| Mechanism of action | • Bupropion (noradrenergic/dopaminergic reuptake inhibitor) reduces