In the study, 118 patients were randomized on a 1:1 basis to receive naproxcinod or naproxen, with escalating doses every three weeks. The trial included three doses of naproxcinod (375mg bid, 750mg bid and a supra-therapeutic dose of 1125mg bid), which were compared to naproxen (250, 500 and 750mg bid). A 24-hour blood pressure monitoring was conducted at baseline and at the end of each three-week dose escalation using an FDA validated, Ambulatory Blood Pressure Monitoring (ABPM) device.
The primary objective of the study was to characterize the 24-hour arterial blood pressure profile of the three doses of naproxcinod, as measured by ABPM after each dose, compared to naproxen. At all time points, naproxcinod showed a decrease in the mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure from baseline in contrast to naproxen. In terms of the overall treatment effect, as an average over week three, six and nine, naproxen raised SBP by 1.5mmHg from baseline, while naproxcinod lowered it by 2.3mmHg, resulting in a difference between the two treatments of 3.8mmHg in favor of naproxcinod.
The three doses of naproxcinod showed good general safety and tolerability. In the naproxcinod arm 32 patients (54.2%) experienced one or more adverse events, compared to 38 patients (64.4%) in the naproxen arm. There were no serious adverse events in the naproxcinod arm.
Naproxcinod is the first investigational drug in the new Cyclooxygenase-Inhibiting Nitric Oxide-Donator (CINOD) class of anti-inflammatory agents, which is nearing the end of Phase III clinical development for the treatment of the signs and symptoms of osteoarthritis, with the submission of a new drug application with the FDA projected for mid-2009.
Michele Garufi, Chairman and CEO of NicOx, said: “These results are an important addition to the consistent data we are accumulating on naproxcinod’s potentially non-detrimental blood pressure profile and its clear differentiation from naproxen. We are confident that naproxcinod’s potential will be confirmed by the further clinical results expected in the coming months.”