FDA Clears ADCIRCA Tablets for Pulmonary Arterial Hypertension

 

May 26, 2009

May 26, 2009 - United Therapeutics Corp. said today the FDA approved ADCIRCA (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).

ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

In the PHIRST-1 randomized, double-blind, 16-week placebo-controlled Phase 3 clinical trial of ADCIRCA for PAH, patients taking ADCIRCA 40 mg (administered as two 20 mg tablets) once daily achieved a 33-meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking ADCIRCA 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushing, nasopharyngitis, respiratory tract infection, nausea, pain in the arms, legs or back, upset stomach and nasal congestion.

For more information: www.unither.com