United Therapeutics Announces FREEDOM-EV Study Of Orenitram Meets Primary Endpoint
SILVER SPRING, Md. and
Orenitram, when taken with an oral PAH background therapy, decreased the risk of a morbidity/mortality event versus placebo by 26% (p=0.0391). Efficacy was observed across the following key subgroups: age, gender,
Secondary endpoints included change from baseline in six-minute walk distance (6MWD), N‑terminal pro-brain natriuretic peptide levels, combined 6MWD and Borg dyspnea score (shortness of breath test) at week 24. Analysis of these secondary endpoints is ongoing.
"We are ecstatic with these results and the potential benefit to PAH patients," said
"We are excited about the opportunity these results provide for more PAH patients to benefit from prostacyclin therapy," added
FREEDOM-EV was a phase 3, international, multi-center, randomized, double-blind, placebo-controlled, clinical worsening study of Orenitram in patients with PAH receiving background oral monotherapy (a phosphodiesterase type 5 inhibitor, an endothelin receptor antagonist or a soluble guanylate cyclase stimulator). Global enrollment was completed in
Detailed study results will be made available through scientific disclosure at upcoming medical society meetings and in peer reviewed publications.
Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (
When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.
Important Safety Information for Orenitram
- Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)
- WARNINGS AND PRECAUTIONS
- Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms
- Orenitram inhibits platelet aggregation and increases the risk of bleeding
- The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum
DRUG INTERACTIONS / SPECIFIC POPULATIONS
- Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other vasodilators increases the risk of symptomatic hypotension
- Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly among patients receiving anticoagulants
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients
- Pregnancy Category C. Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans
- It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding
- Safety and effectiveness in patients under 18 years of age have not been established
- There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients
- In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort.
Please see Full Prescribing Information and Patient Information for Orenitram. For additional information about Orenitram, visit www.orenitram.com or call 1-877-UNITHER (1-877-864-8437).
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the impact of the FREEDOM-EV results on physicians, payers and patients, our plans to submit the FREEDOM-EV results to the
ORENITRAM is a registered trademark of
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