Acura Pharmaceuticals reports successful topline results from Nexafed extended-release clinical study

Acura Pharmaceuticals has announced preliminary topline results from a pilot clinical study which demonstrated bioequivalence of one formulation of NEXAFED (pseudoephedrine HCl) 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- IND meeting with the US Food and Drug Administration (FDA) to review this data and discuss a complete development program.

NEXAFED utilizes enhanced methamphetamine-resistant technology

“These study results validate our ability to move our IMPEDE technology into extended-release formulations”, said Dr. Al Brzeczko, Acura’s Vice President of 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 (Cmax) and extent of absorption (AUC). NEXAFED formulation A met the bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.

For more information about Acura Pharmaceuticals, please visit www.acurapharm.com.