Nexafed extended release found bioequivalent to Sudafed 12-hour tablets


PALATINE, Ill. — Acura Pharmaceuticals on Monday announced preliminary results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed extended-release tablets to Sudafed 12-hour tablets. Nexafed extended-release tablets utilize Acura's Impede 2.0 enhanced methamphetamine-resistant technology. Acura intends to request a pre-investigational new drug meeting with the Food and Drug Administration to review this data and discuss a complete development program.


"These study results validate our ability to move our Impede technology into extended-release formulations," stated Al Brzeczko, Acura's VP technical affairs. "Demonstrating bioequivalence with one formulation this early in our development process allows us to more rapidly advance to discussions with FDA to determine our full development program for this product."


The study was conducted in 12 fasted, healthy subjects and measured the systemic absorption of the active ingredient, pseudoephedrine, from a single dose each of two experimental Nexafed extended-release formulations compared to Sudafed 12-Hour tablets. Nexafed formulation B met FDA's standards for bioequivalence for maximum plasma concentration and extent of absorption. Nexafed formulation A met the bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.

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