Is Opsynvi (Macitentan and Tadalafil) on the market?

On March 22, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi (Macitentan and Tadalafil), sold under the trade name Opsynvi, for the treatment of pulmonary arterial hypertension (PAH) in adults. This marks a significant progress in PAH management. Opsynvi is a single-tablet combination of the endothelin receptor antagonist (ERA) Macitentan and the phosphodiesterase 5 inhibitor (PDE5) Tadalafil that can be taken once daily, providing a convenient and effective treatment option.

Macitentan in Opsynvi is a dual endothelin receptor antagonist (ERA) used to treat pulmonary arterial hypertension (PAH), which was first approved by the FDA in 2013. Tadalafil is a selective phosphodiesterase-5 inhibitor (PDE5) used to treat erectile dysfunction (ED), pulmonary arterial hypertension (PAH) and benign prostatic hypertrophy. The FDA first approved it for ED in 2003 and subsequently for PAH in 2009. Tadalafil has greater selectivity for PDE5 and a longer half-life, making it a more suitable option for long-term once-daily dosing in the treatment of pulmonary hypertension.

The synergistic effects of the two drugs may improve blood flow and reduce pulmonary artery pressure. Clinical trials have proven that Opsynvi is effective in improving exercise capacity, reducing clinical deterioration and improving quality of life in patients with PAH compared with standard treatment alone. It is suitable for treatment-naive patients and patients already receiving treatment for PAH. Opsynvi is available in two strengths and is taken by mouth once daily, but is contraindicated by pregnant women and people allergic to its ingredients.