FDA has approved its intravenous antihypertensive clevidipine
(Cleviprex), which is the first new IV drug for high blood pressure
in 10 years [1].

Clevidipine is a new calcium-channel blocker, which has shown
promise in several studies, including in severe acute hypertension
in the emergency department and in the setting of perioperative
blood-pressure management. Doctors presenting these trials, as
previously reported by heartwire, said the advantages of clevidipine
over current drugs used for acute hypertension--such as sodium
nitroprusside, labetalol, and nicardipine--are that it is easy to
titrate and has an ultrashort half-life of less than one minute.

Rocky path to approval

The path to approval has not been clear of obstacles for
clevidipine, however. In 2005, the company had to halt patient
enrollment in a series of trials in the perioperative setting--known
as ECLIPSE--after patients randomized to the drug showed more
frequent atrial fibrillation (AF) following surgery compared with
patients randomized to comparative treatments.

But the ECLIPSE trials were restarted, and when the results were
presented at ACC 2007 meeting, the lead investigator said that the
AF seen did not appear related to clevidipine. And there was no AF
seen in the VELOCITY study with clevidipine, the very first study
ever to deal with acute hypertension in the emergency department,
according to the lead investigator of that trial, Dr Joseph Varon
(University of Texas Health Science Center, Houston).

Reporting the findings of VELOCITY last year, he told heartwire: "If
I were to put it in a simple way, I would say that clevidipine
is 'supernicardipine.' The beauty of clevidipine is in the short on-
off, and the way we performed the study meant that if we overdid it,
we just stopped the infusion and then the blood pressure came back
to normal. It was an amazing finding. Most of our patients were able
to have their blood pressure controlled within 10 minutes. When you
are dealing with a situation such as emergency care, that's a big
advantage."

The Medicines Company. The Medicines Company's Cleviprex receives
FDA approval [press release]. August 4, 2008. Available at:
http://www.themedicinescompany.com.