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FDA approved macitentan/tadalafil (Opsynvi) as the first single-tablet combination therapy targeting multiple pathways for pulmonary arterial hypertension (PAH), .

The fixed-dose combination of macitentan/tadalafil is now indicated for the chronic treatment of PAH in people who are treatment-naive or who are already on an endothelin receptor antagonist like macitentan (Opsumit), a phosphodiesterase-5 inhibitor like tadalafil (Adcirca), or both.

FDA approval was supported by the phase III A DUE trial and applies to people in World Health Organization (WHO) functional class I, II, or III pulmonary hypertension.

PAH is a progressive disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. It is considered rare, with an estimated 500 to 1,000 new cases diagnosed each year in the U.S.

The draw of dual macitentan/tadalafil is the potential for improving treatment adherence, as PAH and its accompanying comorbidities are associated with a large pill burden. Patients often need diuretics, potassium, and other medications for comorbidities such as diabetes, hypertension, and hyperlipidemia. Just taking the 40-mg dose of tadalafil requires two pills; the new combination tablet fits both drugs into just one tablet.

"As administration of macitentan and tadalafil together are commonly prescribed for initial therapy for PAH, the introduction of a single tablet combining both is promising for clinicians treating patients as it may help bridge the gap between clinical guidelines and everyday clinical practice, while offering a patient-friendly approach to support initial combination therapy and rapid escalation for the appropriate patients," said Kelly Chin, MD, of UT Southwestern Medical Center in Dallas, in a press release.

Chin was an investigator on A DUE, a study of 187 people in WHO functional class II or III that showed that dual macitentan/tadalafil reduced pulmonary vascular resistance nearly 30% more than macitentan and tadalafil monotherapy by week 16. The trial was not large enough to show a benefit in exercise capacity.

As with macitentan monotherapy, receipt of the macitentan/tadalafil combination requires female patients to enroll in an FDA-mandated due to risk of embryo-fetal toxicity.

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