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FDA Approves Orenitram (Extended-Release Treprostinil) for Pulmonary Arterial Hypertension

Walking distance increased versus placebo (December 20)

The FDA has approved Orenitram (treprostinil) extended-release tablets (United Therapeutics Corp.) for the treatment of pulmonary arterial hypertension (PAH) in World Health Organization (WHO) group I patients to improve exercise capacity.

A primary efficacy study, FREEDOM-M, demonstrated that patients receiving Orenitram twice daily improved their median 6-minute walk distance (6MWD) by 23 meters (P = 0.013) compared with patients given placebo. The benefit of Orenitram, a vasodilator, on exercise is small, and the drug has not been shown to add to other vasodilator therapy. Two other phase III studies (FREEDOM-C and FREEDOM-C2) did not demonstrate a benefit in exercise, with median 6MWDs at week 16 of 11 meters (P = 0.072) and 10 meters (P = 0.089), respectively.

The most common side effects reported in clinical studies of Orenitram included headache, nausea, and diarrhea.

Orenitram is dosed twice a day with food, but the total daily dose can be divided and given three times daily with food. Orenitram is available in four strengths: 0.125 mg, 0.25 mg, 1.0 mg, and 2.5 mg. The dose of Orenitram should be increased as tolerated to achieve the optimal clinical response. The maximum dose is determined by tolerability.

Orenitram contains the same active ingredient (treprostinil) as Remodulin injection and Tyvaso inhalation solution, both marketed by United Therapeutics Corp.

Source: United Therapeutics; December 20, 2013.

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