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PLx Pharma completes bioequivalence study of new aspirin formulation

PLx Pharma has successfully completed a clinical trial of PL 2100, also known as Aspirin-PC and demonstrated its bioequivalence with regular aspirin.

This trial demonstrates PL 2100 Aspirin-PC may bridge to the safety and efficacy of aspirin for prescription (Rx) treatment and prevention of secondary prevention of stroke and myocardial infarction and over-the-counter analgesic and fever indications.

According to the company, this trial is a first step in a clinical development program that will investigate PL 2100 Aspirin-PC as an aspirin formulation that is potentially safer for the gastrointestinal (GI) tract. Unlike other approaches to GI safety, such as enteric coated aspirin products which markedly delay the anti-platelet effects, PL 2100 is being investigated for rapid anti-platelet, analgesic and anti-pyretic efficacy with potentially improved gastrointestinal safety.

Byron Cryer, managing director of University of Texas Southwestern Medical School, said: “A GI safer aspirin product that provides rapid anti-platelet activity with pharmacokinetics and pharmacodynamics identical to regular aspirin would be a welcome addition for the safer treatment of cardiovascular diseases and pain.”