Novel Anti-Inflammatory Drug Shows Reduced Effect on Blood Pressure

An investigational drug in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, currently in phase 3 clinical development, has shown promising results for the treatment of the signs and symptoms of osteoarthritis (OA).

Researchers at the University of Pennsylvania (Penn, Philadelphia, USA) and 30 other clinical sites in the United States are participating in a double blind, parallel group study of 118 patients randomized on a 1:1 basis to receive either naproxcinod or naproxen, with escalating doses every three weeks. Three different doses of naproxcinod (375, 750, and a supra-therapeutic dose of 1,125 mg) were compared to naproxen (250, 500, and 750 mg). Continuous ambulatory blood pressure monitoring (ABPM) was conducted at baseline and at the end of each three-week dose escalation. Eligible patients were 40 years and older and had been suffering from OA for at least three months, with at least one hip or knee involved. In addition to OA, all patients were diagnosed with controlled essential hypertension and were being treated with stable doses of up to two different classes of antihypertensive agents. Patients with uncontrolled hypertension were excluded. The study results showed that regarding the primary 24-hour ABPM parameter, systolic blood pressure (SBP), naproxcinod showed a statistically significant decrease in SBP of 3.8 mm Hg compared to naproxen. Furthermore, and in contrast to naproxen, naproxcinod reduced the mean 24-hour SBP and diastolic blood pressure (DBP) from baseline at every dose comparison. Good safety and tolerability were shown by all naproxcinod doses. Naproxcinod is being developed by NicOx (Sophia Antipolis, France).

"These impressive results suggest that naproxcinod could represent a valuable treatment alternative for osteoarthritis patients,” said Raymond Townsend, M.D., a professor of medicine at Penn who advised NicOx on the design and analysis of the study. "The hypertensive side effects of COX-2 inhibitors and traditional NSAIDs are a serious medical issue and there is a clear need for a new drug with no detrimental effect on blood pressure. The use of the ABPM technique gives them considerable weight, as it is widely recognized as the gold standard method for assessing the blood pressure profile of new drugs.”

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen and naproxen are commonly used by OA patients to control their chronic pain, inflammation, and stiffness, and significantly improve quality of life for millions of people. However, they also have the tendency to raise blood pressure to an extent that may increase the rate of serious cardiovascular adverse events.

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University of Pennsylvania
NicOx