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UTHR - +24% gap a pre-marketben...
"DOW JONES NEWSWIRES
United Therapeutics Corp. (UTHR) said Viveta, an inhaled formulation of treprostinil, "robustly" met its primary endpoint in a Phase 3 trial that measured the the drug's effectiveness against pulmonary arterial hypertension.
Patients in the study received Viveta or a placebo in four daily inhalation sessions, with a maxium dose of 45 micrograms per session over the 12-week trial.
The study found that Viveta improved the distance patients were able to walk in six minutes by a median of 20 meters at 12 weeks measured at peak exposure, defined as 10 to 60 minutes after inhalation.
At trough exposure -- at least four hours after inhalation -- the drug improved the distance by a median of 14 meters at 12 weeks and by 18 meters at six weeks.
Preliminary analysis of secondary efficacy measures didn't differ significantly with the placebo group. Analyses of quality of life and symptoms are ongoing.
Viveta was generally well-tolerated in the trial, and adverse events were similar to those previously reported for treprostinil, the Silver Spring, Md., drug developer said."
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