Acura Pharmaceuticals to test absorption rates of extended-release, meth-resistant PSE formulation
PALATINE, Ill. — Acura Pharmaceuticals on Monday announced the initiation of treatment in a pilot clinical study of two experimental formulations of Nexafed (pseudoephedrine HCl) extended-release tablets employing Acura's second-generation methamphetamine resistant technology, Impede 2.0. The study in fasted, healthy subjects will measure the systemic absorption of the active ingredient, pseudoephedrine, from two experimental Nexafed extended-release formulations compared to an FDA-approved 12-hour extended-release reference product. The objective of the study is to characterize the bioavailability profile of the Nexafed formulations for possible adjustment before pivotal human pharmacokinetic testing is undertaken.
"These extended-release Nexafed formulations have met our expectations in the laboratory with respect to both rate of in-vitro release as well as meth-resistance performance," stated Al Brzeczko VP technical affairs at Acura. "This study will provide us with valuable insights into the performance of the products in humans and guide our future development efforts toward a filing with the FDA."
"Advancing these extended-release formulations is critical to our strategy to develop a full-line of meth-resistant pseudoephedrine products," added Bob Jones, Acura president and CEO. "Extended-release products will complement our current Nexafed and Nexafed Sinus offerings and position us to sell into the largest segments of the pseudoephedrine category."
The experimental Nexafed extended-release formulations include Acura's enhanced Impede 2.0 technology that delivers superior meth-resistance in the direct conversion, or "one-pot," methamphetamine conversion process compared to Impede 1.0 and other meth-resistant technologies in the market. Impede 2.0 in the extended-release formulation has demonstrated, in direct conversion tests performed by an independent, international pharmaceutical services company, the ability to reduce meth-yields, on average, by 75% compared to Sudafed Tablets.