Aspertec 325 mg — The First-Ever Liquid-Fill Aspirin Capsule Approved by the FDA

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Company Overview

We are a late-stage specialty pharmaceutical company initially focused on developing our clinically validated and patent-protected PLxGuard delivery system to provide safer and more effective aspirin products. Our PLxGuard delivery system works by releasing active pharmaceutical ingredients into the duodenum, the first part of the small intestine immediately below the stomach, rather than in the stomach itself. We believe this improves the absorption of many drugs currently on the market or in development, and reduces acute gastrointestinal (GI) side effects—including erosions, ulcers, and bleeding — associated with aspirin and ibuprofen, and potentially other drugs.


Our U.S. Food and Drug Administration (FDA) approved lead product, Aspertec 325 mg, is a novel formulation of aspirin that uses the PLxGuard delivery system to significantly reduce acute GI side effects while providing antiplatelet effectiveness for cardiovascular disease prevention as compared with the current standard of care, enteric coated aspirin. A companion 81 mg dose of the same novel formulation — Aspertec 81 mg —is in late-stage development and will be the subject of a supplemental New Drug Application (sNDA) leveraging the already approved status of Aspertec 325 mg.


Our commercialization strategy will target both the over-the-counter (OTC) and prescription markets, taking advantage of the existing OTC distribution channels for aspirin while leveraging the FDA approval of Aspertec 325 mg and expected approval for Aspertec 81 mg for OTC and prescription use when recommended by physicians for cardiovascular disease treatment and prevention. Given our clinical demonstration of better antiplatelet efficacy (as compared with enteric coated aspirin) and better acute GI safety, we intend to use a physician-directed sales force to inform physicians—and, by extension, consumers—about our product’s clinical results in an effort to command both greater market share and a higher price for our new aspirin product.

Our product pipeline also includes other oral nonsteroidal anti-inflammatory drugs (NSAIDs) using the PLxGuard delivery system that may be developed, including a clinical-stage, GI-safer ibuprofen — PL1200 Ibuprofen 200 mg — for pain and inflammation.