PLx Pharma Receives FDA Approval of SNDAs for Two VAZALORE Dosages

PLx Pharma announced the U.S. Food and Drug Administration (FDA) approved supplemental new drug applications (sNDAs) for its lead products, VAZALORE™ 325 mg and VAZALORE™ 81 mg (referred to together as VAZALORE), the first novel, liquid-filled aspirin capsule.

“The approval of the VAZALORE sNDAs marks a significant milestone that brings us closer to providing an innovative aspirin to millions of patients who need reliable and predictable antiplatelet therapy,” said Natasha Giordano, President and Chief Executive Officer of PLx. “We are delighted that the FDA approved both sNDAs for VAZALORE, and we are eager to implement our commercial launch plans later this year. 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.”

In October 2020, the Company submitted separate supplemental new drug applications (sNDAs) for each dose strength. The submissions were considered chemistry and manufacturing control (CMC) filings as they included information on a change in formulation and the new manufacturing site for VAZALORE 325 mg and a new product strength for the 81 mg dose.

The submission for the 325 mg dose also contained the results of a clinical study, demonstrating VAZALORE's bioequivalence to immediate-release aspirin, further supporting the change in formulation. The submission for the 81 mg dose builds off the information in the original approved new drug application, as well as the recent sNDA submitted for VAZALORE 325 mg.

VAZALORE is an FDA-approved liquid-filled aspirin capsule that provides patients with vascular disease and diabetic patients who are candidates for aspirin therapy based on physician recommendation, with fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin. It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.