June 17, 2008
PLx Pharma Demonstrates Bioequivalence With Aspirin and PL 2100 — Aspirin-PC
PLx Pharma Inc.
PLx Pharma Inc. announced today that it 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 (OTC) analgesic and fever indications.
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.
Aspirin is a widely used drug available OTC for pain and fever relief and as directed by a physician for treatment and prevention of myocardial infarction and stroke. When used alone or in combination with other nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs, there is a well documented increased risk for life threatening GI complications, including ulcers and GI bleeding. Recent estimates suggest aspirin may be responsible for nearly 50% of NSAID-induced mortality. PL 2100 Aspirin-PC is a novel formulation of aspirin that combines aspirin with a new gastro- protective agent, phosphatidylcholine (PC).
"Aspirin associated gastrointestinal toxicity poses a significant public health concern," said Byron Cryer, M.D., with the University of Texas Southwestern Medical School and Dallas Veterans Affairs Medical Center, Texas. "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."
About PLx Pharma Inc.
PLx Pharma is a privately owned pharmaceutical company developing GI safer NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen and aspirin) utilizing its novel proprietary phospholipid based technology. This technology complexes a natural soy derived phosphatidylcholine (PC) with a traditional NSAID to mitigate NSAIDs GI toxicity. PLx's lead products are GI safer oral complexes with phosphatidylcholine of ibuprofen (PL 1100 and PL 1200 Ibuprofen-PC which are in clinical development), naproxen (PL 3100 Naproxen-PC) and aspirin (PL 2100 Aspirin-PC). Parenteral formulations, additional oral NSAID-PC and other drug-PC combinations are also under development.
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