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New Use for Active Ingredient of Cialis

Tadalafil, the Active Ingredient in ED Drug Cialis, Approved as Adcirca to Treat Pulmonary Arterial Hypertension

By Miranda Hitti
WebMD Health News

Reviewed by Louise Chang, MD

May 29, 2009 -- The FDA has approved a new use for tadalafil, which is the active ingredient in the erectile dysfunction drug Cialis.

Tadalafil, sold as Adcirca, is now approved to improve exercise ability in people with pulmonary arterial hypertension, which is a rare, life-threatening lung disorder that causes high blood pressure in the lungs.

Adcirca comes in 40 milligram tablets; patients take one tablet per day.

In 2005, the FDA approved Revatio, a pulmonary arterial hypertension drug made with sildenafil, the active ingredient in the erectile dysfunction impotence drug Viagra. Revatio pills are taken three times daily at 20 milligrams per pill.

Adcirca, which will be available in August, is made by the drug company Lilly, which also makes Cialis. Adcirca will be marketed in the U.S. by United Therapeutics Corporation.

The FDA approved Adcirca based on a clinical trial in which pulmonary arterial hypertension patients either took Adcirca (given as two daily tablets, with each tablet containing 20 milligrams of tadalafil) or a placebo pill for 16 weeks.

At the end of the study, the patients walked for six minutes; during that time, patients taking Adcirca walked 33 meters farther than patients in the placebo group. Patients taking Adcirca also had less clinical worsening of their pulmonary arterial hypertension during the study than patients taking the placebo, according to a news release from United Therapeutics.

The most common side effects during the clinical trial included headache; muscle pain; flushing; colds and other respiratory tract infections; nausea; pain in the arms, legs, or back; upset stomach; and nasal congestion. United Therapeutics states that those side effects were generally brief and mild to moderate in intensity.

SOURCES:
FDA.
News release, United Therapeutics Corp.
WebMD Health News: "Viagra Ingredient OK'd for Lung Problem."
Revatio.com.
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