The Food and Drug Administration (FDA) has approved the supplemental New Drug Applications (sNDAs) for Vazalore 325mg and 81mg (PLx Pharma) as the first liquid-filled aspirin capsule.
Vazalore is indicated as a pain reliever, fever reducer, and for aspirin therapy indications. Using a proprietary drug delivery platform, the product is designed to improve the absorption of aspirin by targeting the release of the active ingredient to various portions of the gastrointestinal (GI) tract.
In a randomized, active-controlled, single-blind, triple crossover pharmacokinetic and pharmacodynamic study, the time to complete antiplatelet effect (99% inhibition of thromboxane B2 generation) was observed to be significantly faster with Vazalore 325mg compared with enteric-coated aspirin 325mg (12.5 hours vs 48.2 hours, respectively) among obese patients with type 2 diabetes. Additionally, absorption was found to be 5 times as high as that of enteric-coated aspirin (P <.0001).
Findings from a randomized, single-blind, active-controlled study evaluating upper GI damage following 7 days of aspirin therapy showed that Vazalore 325mg was associated with significantly fewer erosions and ulcers than immediate-release aspirin 325mg in healthy participants.
In addition to clinical data, the sNDA includes bioequivalence data supporting the change in formulation, as well as information regarding a new product strength, Vazalore 81mg.
Vazalore 325mg and 81mg are expected to be commercially available for over-the-counter distribution in the third quarter of 2021.
“We look forward to introducing Vazalore to the medical community and to patients who can benefit from this breakthrough technology designed to reduce the risk of stomach injury,” stated Natasha Giordano, President and Chief Executive Officer of PLx.
1. PLx Pharma receives FDA approval of SNDAs for both Vazalore 325mg and 81mg. [press release]. Sparta, NJ: PLx Pharma Inc.; March 1, 2021.
2. PLx Pharma Inc. Products & Technology: Vazalore 325mg. https://plxpharma.com/products-tech/vazalore-325-mg/?_ga=2.192043946.1811714194.1614622490-1930263889.1614622490. Accessed March 1, 2021.