Source: DGNews  |  Posted 2 years ago

NEW YORK -- May 26, 2009 -- The US Food and Drug Administration (FDA) has approved once daily tadalafil (Adcirca) tablets, with a recommended dose of 40 mg, for the treatment of pulmonary arterial hypertension (PAH).

Tadalafil 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.

The approval is based on the randomised, double-blind, 16-week placebo-controlled phase 3 clinical trial of tadalafil (PHIRST-1).

In the study, patients with PAH received tadalafil 40 mg, administered as two 20 mg tablets once daily or a placebo.

Patients in the tadalafil group achieved a 33 meter improvement in 6-minute walk distance compared with the placebo group.

n addition, patients taking tadalafil experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalisation because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared with 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.

SOURCE: United Therapeutics Corporation