Oral form of Remodulin approved

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United Therapeutics said Friday that the FDA approved Orenitram (treprostinil), its oral formulation of pulmonary arterial hypertension treatment Remodulin (treprostinil). The agency sanctioned the extended-release tablets for treating PAH in WHO Group I patients to improve exercise capacity.

The FDA had rejected the drug twice before, once in October 2012 and again this past March. In response to the second CRL, the company resubmitted the drug in September, and at the time the firm said that the new PDUFA date was February 2014.

In its statement Friday, the company said the drug confers a "small" treatment effect. In one study, FREEDOM-M, patients on Orenitram twice daily improved their median six-minute walk distance by +23 meters as compared to patients receiving only placebo. Two other Phase III studies did not demonstrate a benefit.

On a conference call this morning, according to a recap from ISI Group analyst Mark Schoenebaum, management said it will launch the drug in the next six months and that it will be distributed through the same specialty pharmacies as its other PAH drugs, Remodulin and Tyvaso, which is an inhaled version of the same active ingredient as that of Remodulin and Orenitram.
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