New Blood Pressure Medication Receives FDA Approval

The new intravenous (IV) treatment for hypertension known as Cleviprex is the first to be approved by the Food and Drug Administration (FDA) in a decade. The Medicines Company, a maker of pharmaceuticals located in Parsippany, New Jersey, announced that the FDA has approved Cleviprex (clevidipine butyrate) injectable emulsion for patients with difficult-to-treat high blood pressure and for those patients who cannot take oral medications. The company specializes in the manufacture of pharmaceuticals for the hospital market.

Cleviprex offers fast and accurate control of blood pressure for critical care in areas such as the emergency room, operating room, and intensive care unit with a broad amount of data backing its success. Cleviprex has a rapid onset and offset of action in determining the smallest amount of concentration necessary for precise blood pressure control. In addition, Cleviprex does not accumulate in the body, as it metabolized in the blood and tissues, which is different from many current IV hypertension drugs that are metabolized by the kidney and/or liver.

“With the approval of Cleviprex, The Medicines Company continues to deliver on its vision of advancing innovation in the critical care setting,” said Clive Meanwell, Chief Executive Officer of The Medicines Company.

John Kelley, President and Chief Operating Officer of The Medicines Company commented, “In the last decade, there have been no new IV antihypertensive agents introduced to the market.” He also added that, “Cleviprex presents physicians with a valuable option to effectively treat a broad array of patients who need rapid and precise blood pressure control.” High blood pressure is a condition that can be life threatening and can cause permanent brain, heart, kidney and blood vessel damage when left untreated.

Cleviprex is an IV dihydropyridine calcium channel blocker. Six Phase III trials involving 1,406 medical and surgical patients treated with Cleviprex were the basis for the first-cycle U.S. approval of the drug. The Phase III trials met all of their primary endpoints.

The use of Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions seen with the use of Cleviprex, are headache, nausea and vomiting at an incidence of less than 2 percent.