Acura Pharmaceuticals has started a pilot clinical trial of two experimental formulations of Nexafed (pseudoephedrine HCl) extended-release tablets using the company’s second generation methamphetamine resistant technology, IMPEDE 2.0.
Healthy and fasted subjects will be included in the trial, which is designed to 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 trial is aimed at characterising the bioavailability profile of the Nexafed formulations for possible adjustment before pivotal human pharmacokinetic testing is undertaken.
The experimental Nexafed extended-release formulations include the company’s improved 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.
The company said that IMPEDE 2.0 in the extended-release formulation has showed, in direct conversion tests performed by an independent, international pharmaceutical services firm, the ability to reduce meth-yields, on average, by 75% compared to Sudafed Tablets.
Acura Technical Affairs vice-president Dr Al Brzeczko said: "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.
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"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."
Nexafed is one of the company’s next generation pseudoephedrine products built around IMPEDE technology, which uses a polymer matrix to disrupt the conversion of pseudoephedrine into the dangerous drug, methamphetamine.
Acura president and CEO Bob Jones said: "Advancing these extended-release formulations is critical to our strategy to develop a full-line of meth-resistant pseudoephedrine products.
"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 company has introduced Nexafed (pseudoephedrine HCl) 30mg tablets in December 2012 and the only meth-resistant combination pseudoephedrine product, Nexafed Sinus Pressure + Pain (pseudoephedrine HCl/acetaminophen) 30/325mg tablets in February 2015.