Naproxen Gets Makeover from NicOx

November 16, 2007, 3:32 pm
Naproxen Gets Makeover from NicOx
Posted by Scott Hensley

nullWith pipelines sputtering, the drug industry is rife with companies trying to teach old medicines new tricks.

Just yesterday, we wrote about Cogentus Pharmaceuticals’ concept to combine the ingredients in blood-thinner Plavix and heartburn-stopper Prilosec in a single pill to reduce gastrointestinal bleeding risks. (A few of our commenters seemed less than enthralled by the business case for that idea, however.)

But the landmark Merck settlement over Vioxx’s risks reminded us of a conversation we had recently with Michele Garufi, CEO of NicOx, a French biotech. What’s the connection, you ask? Well, NicOx is rejiggering good ol’ generic naproxen (sold over the counter as Aleve) to mitigate its cardiovascular side effects.

Recall that the FDA required that all NSAIDs, including naproxen, carry beefed-up warnings about heart risks in 2005.

So NicOx is working on a version of naproxen that doesn’t raise blood pressure–an appealing prospect to arthritic patients at risk of heart attack and strokes. NicOx’s trick consists of attaching nitric oxide to the naproxen, creating naproxcinod. In the body, nitric oxide is a powerful signaling chemical that, among other things, helps relax blood vessel walls.

Earlier this month, the company presented data from late-stage testing of naproxcinod at scientific meetings of the American College of Rheumatology and the American Heart Association. So far, the drug appears effective in relieving arthritis pain, as you’d expect, and it doesn’t raise blood pressure compared with placebo either. “We’ll be the only one that will be able to show we’re like placebo on blood pressure in long-term trials,” Garufi told the Health Blog.

The drug appears to be moving toward regulatory approval, and the company could file with regulators for approval early in 2009. Whether doctors, patients and health insurers will find a tweaked version of naproxen appealing at a brand-name price remains to be seen. Garufi is optimistic: “Doctors are sensitized to the (safety) issues. We think it’s enough to sell.”

As the drug moves toward approval NicOx is searching for a marketing partner. Already the company has development deals for other drugs with Merck and Pfizer.
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