The FDA has approved Adcirca tablets (tadalafil, from United Therapeutics), a once-daily oral phosphodiesterase type 5 (PDE5) inhibitor, for the treatment of pulmonary arterial hypertension (PAH). Adcirca is indicated to improve exercise ability in World Health Organization (WHO) Group I PAH patients, including patients with multiple forms of PAH (eg, idiopathic PAH, familial PAH, PAH associated with scleroderma and congenital heart disease).
This approval was based on results from a Phase 3, 16-week, randomized, double-blind, placebo-controlled trial in patients with PAH. Patients who received Adcirca demonstrated a 33 meter improvement in six-minute walk distance and experienced less clinical worsening (ie, death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to patients treated with placebo.
Adcirca is expected to be made available in early August 2009 in a 20mg dosage strength.
For more information visit www.adcirca.com.