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NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study
Date:11/4/2008

results suggest that naproxcinod could represent a valuable treatment alternative for osteoarthritis patients," said Raymond Townsend, Professor of Medicine at the University of Pennsylvania, 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. These ABPM data have been obtained in a relevant population of chronically treated osteoarthritis patients with many cardiovascular risk factors and clearly show a consistent beneficial effect on blood pressure for naproxcinod across the dose range, in contrast to naproxen. In addition, 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."

The 111 study design and results

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 (375 mg bid, 750 mg bid and a supra-therapeutic dose of 1125 mg bid), which were compared to naproxen (250, 500 and 750 mg bid). 24-hour blood pressure monitoring was conducted at baseline and at the end of each three-week dose escalation (i.e. at the end of week 3, 6 and 9), using an FDA validated, 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 SBP and DBP from baseline in contrast to naproxen. In terms of the overall treatment effect, as an average over week 3, 6 and 9, naproxen raised SBP by 1.5 mmHg from baseline, while naproxcinod lowered it by 2.3 mmHg, resulting in a difference between the two treatments of 3.8 mmHg (p=
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Related medicine technology :

1. NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
2. NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
3. NicOx Completes Enrollment of Two Ambulatory Blood Pressure Measurement (ABPM) Studies for Naproxcinod in Hypertensive OA Patients
4. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
5. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
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