Parsippany, NJ - The Medicines Company has announced that the US 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.

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."