Our lead product, Vazalore 325 mg, is NDA-approved by the FDA for OTC distribution and is the first-ever FDA-approved liquid-filled aspirin capsule. All the clinical trials necessary for product launch have been completed.
Vazalore: Unlocking Aspirin’s Full Potential
Vazalore 325 mg is faster acting, has a 4 times greater rate of absorption and better extent of bioavailability than the current standard of care for cardiovascular disease prevention and treatment, enteric coated (EC) aspirin. (Source: Reliable Inhibition of Thrombocyte Activity: Comparison of Vazalore Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study), September 24, 2014)
Vazalore 325 mg provided twice as many patients’ cardio protection as evidenced by a complete aspirin response compared with EC aspirin. (Source: Reliable Inhibition of Thrombocyte Activity: Comparison of Vazalore Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study), September 24, 2014)
For both the high risk clinical setting where the risks of cardiovascular and GI events are high, and in real clinical practice where compliance is generally poor, Vazalore 325mg may be a more attractive choice of an aspirin dose form than EC aspirin to constitutively suppress platelet derived thromboxane generation. Hazard ratios, a measure of risk, for two studies reveal Vazalore 325 mg has a 3.4x to 5.0x greater chance of achieving a complete antiplatelet response than EC Aspirin. (Source: A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of Vazalore 325mg Versus Enteric-Coated and Immediate-Release Aspirin in Patients with Type II Diabetes, May 15, 2013; PL-ASA-004 CSR and Reliable Inhibition of Thrombocyte Activity: Comparison of Vazalore Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study), September 24, 2014.)
Vazalore 325 mg also demonstrated at least a 65% reduction in the risk of acute ulceration in the stomach and the duodenum compared to regular, immediate-release aspirin. (Source: Cryer, B., et al., Low-dose aspirin-induced ulceration is attenuated by aspirin-phosphatidylcholine: a randomized clinical trial. Am J Gastroenterol, 2011. 106(2): p. 272-7.; A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by Vazalore 325mg Versus Aspirin in At-Risk Subjects.)