Nexafed™ Tablets

Nexafed™ Tablets

Our Nexafed product (formerly referred to as Impede™ PSE) is an immediate-release pseudoephedrine HCl tablet which utilizes our patent pending Impede Technology. Impede Technology, a proprietary mixture of inactive ingredients, is designed to limit or impede extraction of PSE from tablets for use as a starting material in producing methamphetamine.

Development Program

Study AP-SZY-2001 is an 18 subject crossover pharmacokinetic study to evaluate the plasma concentrations of: (a) 2 x 30mg Nexafed Tablets, (b) 2 x 30mg Sudafed® Tablets, and (c) 2 x 30mg generic PSE tablets (also known as a “store brand”). The study demonstrated that Nexafed Tablets are bioequivalent to Sudafed and to the store brand pseudoephedrine HCl tablets.

Acura sponsored an independent pharmaceutical laboratory test of our Nexafed Tablets compared to Sudafed brand PSE tablets in an attempt to extract PSE from 100 x 30mg tablets for conversion to methamphetamine using what we believe to be the three most commonly used methamphetamine conversion processes. The results of these tests demonstrated that while PSE was readily extracted from Sudafed tablets, Nexafed effectively impeded the extraction of the PSE for conversion into methamphetamine. The results of these tests are summarized in the table below.

Status

We provided Nexafed tablet samples to scientists associated with a law enforcement agency for their testing. The law enforcement testing demonstrated that the Impede™ Technology blocked the extraction of pseudoephedrine in several tests that were conducted under various conditions. In one test method, however, an unknown amount of methamphetamine, with unknown purity, was reportedly produced. We are assessing the results of these studies and intend to perform our own tests to better understand this finding. As a result, we have delayed commercialization activities on Nexafed pending these tests.

Sudafed® is a registered trademark of Johnson & Johnson Corporation.