Vazalore 325 mg

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

Time to Complete Antiplatelet Effect

Bhatt DL, et al. Enteric Coating and Aspirin Non-Responsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol 2017 Feb 14;69(6):603-612

PL2200 = Vazalore™
Plain Aspirin = Immediate Release Aspirin Tablets

In this study, Vazalore achieved 99% inhibition of thromboxane B2 generation significantly faster (12.5 hours) than enteric coated aspirin (48.2 hours) (p<0.0001)1

This study design cannot provide data on cardiovascular outcomes.

Plasma ASA Concentration Versus Time

Bhatt DL, et al. Enteric Coating and Aspirin Non-Responsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol 2017 Feb 14;69(6):603-612

PL2200 = Vazalore™
Plain Aspirin = Immediate Release Aspirin Tablets

In this study population the AUC of plasma concentrations were: Vazalore (2523), immediate release aspirin (1964), and enteric coated aspirin (456).
Thus, absorption with Vazalore was 5X as high as that of enteric coated aspirin (p<0.0001)1

This study design cannot provide data on cardiovascular outcomes.

Inhibition of TXB2 Generation by 72 hours

Bhatt DL, et al. Enteric Coating and Aspirin Non-Responsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol 2017 Feb 14;69(6):603-612

PL2200 = Vazalore™
Plain Aspirin = Immediate Release Aspirin Tablets

In this study population, by 72 hours, Vazalore provided complete antiplatelet effect (≥99% inhibition of TXB2 generation) for almost twice as many patients as enteric coated aspirin1

This study design cannot provide data on cardiovascular outcomes.

 

 

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

Upper GI Damage Comparison

Bhatt DL, et al. Enteric Coating and Aspirin Non-Responsiveness in Patients With Type 2 Diabetes Mellitus. J Am Coll Cardiol 2017 Feb 14;69(6):603-612

PL2200 = Vazalore™
Aspirin = Immediate Release Aspirin Tablets

In this study, Vazalore caused significantly fewer erosions and ulcers than immediate release aspirin after 7 days of therapy2:
• 47% lower risk of erosions or ulcers (NNT=5)
• 71% lower risk of ulcers (NNT=8)