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news.PLx Pharma has started a Phase I clinical trial of PL 2100, also known as Aspirin-PC, its oral drug candidate for equivalent label claims for aspirin under a 505(b)(2) regulatory path.
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This trial is a randomized, single dose, crossover study that will evaluate the acute safety, tolerability, pharmacokinetics and anti-platelet equivalence of aspirin compared with PL 2100 Aspirin-PC at 325mg and 650mg dose levels in approximately 32 healthy volunteers. 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.
There are two active investigational new drug applications for PL 2100, for prescription and non-prescription uses, with this trial designed to address the regulatory requirements of both. PL 2100 Aspirin-PC is novel formulation of aspirin that combines aspirin with a new gastro-protective agent, phosphatidylcholine.
Lenard Lichtenberger, co-founder of PLx Pharma, said: “PL 2100 Aspirin-PC may represent an alternative treatment for the large numbers of patients at risk for GI complications from aspirin use alone or when using aspirin with other drugs.”