Opsumit belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood pressure in the lungs, according to the FDA.
The drug’s safety and effectiveness were established in a long-term clinical trial in which 742 participants were randomly assigned to take Opsumit or placebo, the FDA reported. In the study, Opsumit was effective in delaying disease progression, a finding that included a decline in exercise ability, worsening symptoms of PAH or need for additional PAH medication.
Opsumit will carry a Boxed Warning, as do other entries in its drug class, alerting patients and health care professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program.
More information is available on the Actelion Pharmaceuticals website.