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.
Clinical Study—PK/PD Comparison: Plain Aspirin, Vazalore, Enteric Coated Aspirin1
In a single-center, randomized, active-controlled, single-blind, triple crossover pharmacokinetic (PK) and pharmacodynamic (PD) study of antiplatelet activity over 3 days, in obese patients with type 2 diabetes.1
Clinical Study—Upper GI Injury: Plain Aspirin vs Vazalore2
In a randomized, single-blind, multicenter active-controlled study of upper GI damage of aspirin in healthy subjects following 7 days of oral 325 mg once daily, immediate release aspirin tablets or Vazalore (PL2200).2
References: 1. Bhatt DL, Grosser T, Dong JF, et al. Enteric coating and aspirin nonresponsiveness in patients with type 2 diabetes mellitus. JACC. 2017;69(6):603-612. 2. Cryer B, Bhatt DL, Lanza FL, et al. Low-dose aspirin-induced ulceration is attenuated by aspirin–phosphatidylcholine: a randomized clinical trial. Am J Gastroenterol. 2011;106(2):272-277.