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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 Parsippany,
New Jersey. The drugmaker already
sells the anti-clotting agent Angiomax.
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.
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