PALATINE, Ill. — Acura Pharmaceuticals on Monday announced a second-generation prototype formulation of its methamphetamine-resistant IMPEDE technology with pseudoephedrine hydrochloride yielded no measurable amount of methamphetamine hydrochloride when processed in the direct conversion or one-pot method.
“We are excited to advance our IMPEDE technology demonstrating its adaptability to the ever changing meth production problem,” stated Robert Jones, president and CEO of Acura Pharmaceuticals. “Nexafed is the only meth-resistant pseudoephedrine product on the market that meets the Food and Drug Administration’s bioequivalence standards for demonstrated effectiveness. If Nexafed with IMPEDE 2.0 can also meet that standard, we believe we will have a meth-resistant pseudoephedrine product that delivers unmatched performance.”
Acura intends to immediately commence development of an upgraded Nexafed tablet using IMPEDE 2.0.
IMPEDE 2.0 was created through the addition of two new inactive pharmaceutical ingredients to Acura’s existing IMPEDE technology. IMPEDE 2.0 was tested by an outside laboratory using an optimized, high-yield direct conversion test method that is designed to replicate the direct conversion, or one-pot, process commonly utilized by clandestine methamphetamine laboratories.
IMPEDE 2.0 yielded no measurable amount of methamphetamine in its initial testing compared to an approximate 38% yield with the older IMPEDE technology. Acura intends to validate these results and perform its battery of extraction tests on the reformulated NEXAFED tablets.