"The launch of Nexafed® is a significant milestone for
Nexafed® delivers the same efficacy as leading pseudoephedrine products. In a clinical study Nexafed® was shown to meet the
Pseudoephedrine, a decongestant used in some cold and allergy medicines, is the primary ingredient converted during illegal methamphetamine production. Unlike other cold and allergy pseudoephedrine products, Nexafed® is the only medicine that utilizes
Laboratory tests conducted on
"The introduction of cold and allergy products with abuse-deterrent technologies is a significant step forward for communities across the country affected by the debilitating effects of meth production," said
Methamphetamine production and abuse is a serious problem that has become increasingly common in communities across the U.S. In 2011, approximately 439,000 Americans ages 12 years and older had abused methamphetamine.(2) The impact of methamphetamine extends beyond those who use and abuse the drug. Methamphetamine production creates increased danger in communities from fire, explosions, exposure to toxic chemicals and crime.
Last year, more than 10,000 clandestine labs were found in the U.S., triggering environmental hazards and requiring expensive and timely cleanup by local governments.(3) In addition to environmental hazards, the economic cost of methamphetamine use in the U.S. -- estimated at
"We hope the availability of Nexafed® empowers pharmacists to impact meth abuse at a local level by stocking and recommending the product," said Jones. In a recent market research study, 70 percent of chain and independent pharmacists involved in pharmacy stocking decisions said they were likely to stock or recommend stocking Nexafed® in their pharmacies. These pharmacists further indicated a willingness to recommend Nexafed® to over 50 percent of their customers who seek a pharmacist's advice in need of a single ingredient nasal decongestant like Nexafed®.
Nexafed® is now available to national and regional drug wholesalers and will be available to pharmacies soon.
Nexafed® [pseudoephedrine hydrochloride (HCl)] is a 30 mg immediate-release abuse-deterrent decongestant. The next generation pseudoephedrine tablet combines effective nasal-congestion relief with Impede™ technology, a unique polymer matrix that disrupts the conversion of pseudoephedrine into the dangerous drug, methamphetamine. Specifically, the Impede(™) technology 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.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to, the timing of, our ability to successfully launch and commercialize Nexafed® Tablets, the market acceptance of and competitive environment for any of our products, the willingness of wholesalers and pharmacies to stock Nexafed® Tablets, expectations regarding potential market share for our products and the timing of first sales, the adequacy of the results of the laboratory and clinical studies completed to date, the sufficiency of our development to meet over-the-counter, or OTC, Monograph standards as applicable, adverse safety findings relating to our product candidates, our exposure to product liability and other lawsuits in connection with the commercialization of our products, the increasing cost of insurance and the availability of product liability insurance coverage, and whether our Impede™ technology, including our Nexafed® Tablets, will disrupt the processing of pseudoephedrine into methamphetamine. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "indicated," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the
(1) Data on file;
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Pete Clemens Acura PharmaceuticalsEmail Contact (847) 705-7709 Media: Leticia DiazSpectrum Email Contact (202) 955-6222
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