FDA clears Cleviprex as first new IV antihypertensive drug in decade

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Cleviprex to present a new IV antihypertensive treatment in critical care settings. Source: Medicines Company  

The FDA has approved the Medicines Company’s intravenous therapy Cleviprex injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Cleviprex, an intravenous (IV) antihypertensive, provides control of blood pressure in the critical-care setting, which is backed by data in the emergency department, operating room and intensive care unit. according to the Parsippany, N.J.-based company.

The company also said its Cleviprex (clevidipine butyrate) has a rapid onset and offset of action and can be titrated for blood pressure control. Unlike many current IV antihypertensive agents, metabolized by the kidney and/or liver, Cleviprex is metabolized in the blood and tissues and does not accumulate in the body.

"In the last decade, there have been no new IV antihypertensive agents introduced to the market," said John Kelley, president and chief operating officer of the Medicines Company.

The company has planned to launch Cleviprex in September.

At the 2008 Society of Critical Care Medicine (SCCM) meeting, W. Frank Peacock, MD, and colleagues from the Cleveland Clinic reported that Cleviprex was safe and effective in patients with renal dysfunction and in those with acute heart failure. The data were from phase III of the VELOCITY trial, an open-label, single-arm, multi-center study in 126 emergency department patients presenting with acutely elevated blood pressure.

Primary endpoints were the percentage of patients within initial target blood pressure range by 30 minutes, and the percentage below that range after three minutes of initiating Cleviprex.

Researchers found that target blood pressure control was achieved with Cleviprex by a median of 6.3 minutes for patients with renal dysfunction and 11.3 minutes for patients with acute heart failure. They reported that 91 percent of renal dysfunction patients (N=24) and 94 percent of acute heart failure (N=19) patients reached their target within 30 minutes. The remaining patients reached their target range after 30 minutes.

Most patients (88 percent renal dysfunction, 84 percent acute heart failure) transitioned smoothly to an oral antihypertensive after completing treatment with Cleviprex. In these analyses, there were no hypotensive events and Cleviprex was well tolerated.

Independent research from Duke University Medical Center, also presented at SCCM, of a Duke Heart Center database of 5,000 patients demonstrated that blood pressure above or below a target range was significantly linked to 30-day mortality in cardiac surgery patients.

"The impetus for the Duke database analysis were the ECLIPSE results, which showed that improved blood pressure control in cardiac surgery patients significantly reduced the risk of death within 30 days following the procedure," said Solomon Aronson, MD, a professor of anesthesiology at Duke.

"These data clearly demonstrate the need to reevaluate the management of acute blood pressure changes during surgery. Furthermore, these data alert us to an important and emerging unmet clinical need for new target therapies that better manage and control severe blood pressure excursions in the hospital," Aronson said.