The Medicines Company announced that the results of Velocity, a pivotal phase-3 safety and efficacy trial of its new intravenous (IV) therapy Cleviprex (clevidipine butyrate) injectable emulsion, were published in the August issue of the Annals of Emergency Medicine.
The clinical trial demonstrated that Cleviprex is safe and effective for the treatment of acute, severe hypertension. Cleviprex was approved this month by the US Food and Drug Administration (FDA) for the reduction of blood pressure when the use of oral therapy is not feasible or not desirable.
Velocity, a prospective, multicenter, open-label, single-arm study, evaluated the safety and efficacy of Cleviprex in 126 patients in the emergency room or intensive care unit who had acute, severe hypertension (defined as systolic blood pressure greater than 180 mm Hg and/or diastolic blood pressure greater than 115 mm Hg). Cleviprex was administered using non--weight-based dosing, and infusions were adjusted to rapidly bring blood pressure to a physician-specified target range using blood pressure cuff monitoring. The primary efficacy endpoint was the percentage of patients in whom systolic blood pressure was successfully reduced to the target range within 30 minutes of initiating therapy.
"The Velocity study demonstrates the ability of Cleviprex to control blood pressure rapidly and predictably in patients with acute, severe hypertension," said lead investigator Charles Pollack, University of Pennsylvania, Department of Emergency Medicine. "With the recent approval of Cleviprex, physicians will have a valuable therapy to help effectively manage and maintain these patients in the critical care setting."
Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle US approval of Cleviprex was based on six phase-III trials involving 1,406 patients medical and surgical patients treated with Cleviprex.
The Medicines Company is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace.