The Medicines Company (NASDAQ: MDCO) announced that its investigational agent, CleviprexTM (clevidipine butyrate) injectable emulsion was well tolerated in elderly patients and rapidly achieved and maintained blood pressure control in patients presenting to the emergency department or intensive care unit with acutely elevated blood pressure (n=27), according to a post-hoc analysis of the Phase 3 VELOCITY1 trial. VELOCITY was an open-label, single-arm, multi-center study in 126 emergency department patients presenting with acutely elevated blood pressure.
The analysis, which was presented at the annual meeting of the Society of Academic Emergency Medicine (SAEM), evaluated the safety and efficacy of Cleviprex in patients 65 years and older. Target blood pressure control was achieved with Cleviprex, administered by intravenous (IV) infusion, at a median of 5.8 minutes in these elderly patients and more than 96 percent of patients reached their target blood pressure range within 30 minutes. A continuous 18-hour infusion of Cleviprex was well-tolerated in the majority of elderly patients, with successful transition to oral therapy.
“Currently available options for the treatment of acutely elevated blood pressure are often not ideal for elderly patients due to contraindications with comorbidities,” said Charles Pollack, MD, Professor of Emergency Medicine, University of Pennsylvania. “The poor health of these elderly patients can make treatment in the hospital setting a real challenge.”
Most of the elderly patients in the analysis had end-organ damage at baseline with more than 20% suffering from existing renal disease (including dialysis dependent patients). While more than half of the patients in the analysis experienced an adverse event, most of the events were assessed as unrelated to Cleviprex.
“There is clearly a need in the marketplace for treatment alternatives for elderly patients with acute elevations of blood pressure,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “It is critical to carefully manage this high-risk patient group.”
The Risk of Acutely Elevated Blood Pressure
Acutely elevated blood pressure, or acute hypertension, is a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. Each year, more than 3 million people are treated with intravenous antihypertensive drugs in U.S. hospitals for acute elevations of blood pressure. It is critical to rapidly manage and maintain optimal blood pressure to minimize risk of death and damage to vital organs.
Cleviprex is a novel investigational IV antihypertensive for the treatment of acutely elevated blood pressure, when the use of oral therapy is not feasible or desirable. Cleviprex has a rapid onset and offset of action and can be titrated for predictable blood pressure control. Unlike current antihypertensive treatments which are metabolized by the kidney or liver, Cleviprex is metabolized in the blood and does not accumulate in the body.
Six Phase III trials of Cleviprex met all of their primary endpoints. The most common adverse reactions seen with Cleviprex use were headache, sinus tachycardia, hypotension, nausea, polyuria, flushing, dizziness and vomiting.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Company also has two products in late-stage development, CleviprexTM (clevidipine butyrate) injectable emulsion and cangrelor. The Company’s website is themedicinescompany.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “believes,” “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company’s products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company’s periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company’s Quarterly Report on Form 10-Q filed on May 12, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
1 eValuation of the Effect of uLtrashOrt-Acting Clevidipine In the Treatment of patients with severe hYpertension
The Medicines Company
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