The Food and Drug Administration has approved the injectable drug Cleviprex for patients with difficult-to-treat high blood pressure and for those who cannot take oral medications.
Cleviprex is the first non-pill drug to
receive approval for high blood pressure in 10 years, according to Medicines Co.,
a maker of pharmaceuticals located in
Cleviprex is a novel investigational IV antihypertensive for the treatment of acute hypertension when the use of oral therapy is not feasible or desirable. The drugmaker says it 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 tissue and blood and does not accumulate in the body, making it suitable for patients with end-organ damage and causing less buildup in the body.
The drug has been studied in clinical trials and Six Phase III Trials of Cleviprex met all their primary endpoints. The most common adverse reactions associated with the use of Cleviprex are headache, nausea and vomiting at an incidence of less than 2 percent.
The drug will be launched in September, company spokesman Robyn Brown said in an e-mail to Reuters.
“With the approval of Cleviprex, physicians have a new treatment option for intensive control of blood pressure that may advance the standard of care in the operating room, the intensive care unit and the emergency department,” Robert Califf, professor of medicine and vice chancellor for research at Duke University, said in a statement.