Acura Pharmaceuticals Reports Successful Topline Results From Nexafed(R) Extended-Release Clinical Study

PALATINE, IL--(Marketwired - March 23, 2015) - Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today 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.

"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.

About NEXAFED and IMPEDE      
NEXAFED is Acura's line of next generation pseudoephedrine products built around IMPEDE technology, that uses a unique polymer matrix to disrupt the conversion of pseudoephedrine into the dangerous drug, methamphetamine. Specifically, IMPEDE tablets forms a thick gel when the tablets are dissolved in solvents typically used in the pseudoephedrine extraction or methamphetamine production processes, trapping the pseudoephedrine or converted methamphetamine to prevent its isolation or purification. Acura commercially launched NEXAFED (pseudoephedrine HCl) 30mg tablets in December 2012 and the only commercially available meth-resistant combination pseudoephedrine product, NEXAFED Sinus Pressure + Pain (pseudoephedrine HCl/acetaminophen) 30/325mg tablets in February 2015. The NEXAFED line is available at national and regional drug, grocery and mass merchandiser pharmacies. NEXAFED delivers the same efficacy and is priced comparably to similar branded pseudoephedrine products.  For more information about NEXAFED, please visit www.nexafed.com.