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FREEDOM-M Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:6/6/2011

gement on a one-hour conference call to answer questions related to FREEDOM-M.

The conference call is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the conference call will be available for two weeks and can be accessed by dialing 1-800-642-1687, with international callers dialing 1-706-645-9291, and using conference code: 72976350.

This conference call is also being webcast and can be accessed via our website at http://ir.unither.com/events.cfm.

About Tyvaso (treprostinil) Inhalation Solution

Indication

Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor).  The controlled clinical experience was limited to 12 weeks in duration.

Important Safety Information

  • TYVASO is intended for oral inhalation only. TYVASO is approved for use only with the TYVASO Inhalation System.
  • The safety and efficacy of TYVASO have not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease) and in patients under 18 years of age.  Patients with acute pulmona
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SOURCE United Therapeutics Corporation
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