Acura Pharmaceuticals Announces Successful Bioequivalent Study forNEXAFED
PALATINE, IL, Nov 20, 2012 (Menafn - MARKETWIRE via COMTEX) --Acura Pharmaceuticals, Inc. ACUR, a specialtypharmaceutical company developing products intended to addressmedication abuse and misuse, announced today topline results from aclinical study that demonstrates Acura's NEXAFED (pseudoephedrinehydrochloride) is bioequivalent to the leading national brandproduct. The study was a Phase 1 pharmacokinetic study in 30 healthyadult subjects to confirm that changes made to the formulation forNEXAFED to improve manufacturability in support of a national launchwill continue to provide effective relief of nasal congestionexpected by pharmacists and consumers.
NEXAFED is a 30 mg immediate-release next generation pseudoephedrinetablet, which combines effective nasal-congestion relief with Acura'sunique IMPEDE technology that disrupts the conversion ofpseudoephedrine into the dangerous drug, methamphetamine.
"It is important that our IMPEDE technology used in NEXAFED does notcompromise the effectiveness of the active ingredient, and theresults of our clinical study demonstrate this," said Bob Jones,President and Chief Executive Officer of Acura Pharmaceuticals. "Weremain on track for a national launch of NEXAFED later this year."
About Acura Pharmaceuticals Acura Pharmaceuticals is a specialtypharmaceutical company engaged in the research, development andcommercialization of product candidates intended to addressmedication abuse and misuse, utilizing its proprietary AVERSION(R)and IMPEDE(TM) technologies. In June 2011, the U.S. Food and DrugAdministration approved OXECTA(R) which incorporates the AVERSION(R)technology. The Company has a development pipeline of additionalAVERSION(R) technology products including other opioids and itsIMPEDE(TM) technology for pseudoephedrine hydrochloride products.
The trademark OXECTA(R) is owned by Pfizer Inc.
Forward-Looking Statements Certain statements in this press releaseconstitute "forward-looking statements" within the meaning of thePrivate Securities Litigation Reform Act of 1995. Suchforward-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 anyfuture results, performance, or achievements expressed or implied bysuch forward-looking statements. Forward-looking statements mayinclude, but are not limited to, the timing of, and our ability tosuccessfully launch and commercialize NEXAFED Tablets, the marketacceptance of and competitive environment for any of our products,the willingness of wholesalers and pharmacies to stock NEXAFEDTablets, expectations regarding potential market share for ourproducts and the timing of first sales, the adequacy of the resultsof the laboratory and clinical studies completed to date, thesufficiency of our development to meet over-the-counter, or OTC,Monograph standards as applicable, adverse safety findings relatingto our product candidates, our exposure to product liability andother lawsuits in connection with the commercialization of ourproducts, and whether our IMPEDE technology, including our NEXAFEDTablets, will disrupt the processing of pseudoephedrine intomethamphetamine. In some cases, you can identify forward-lookingstatements by terms such as "may," "will," "should," "could,""would," "expects," "plans," "anticipates," "believes," "estimates,""projects," "predicts," "potential" and similar expressions intendedto identify forward-looking statements. These statements reflect ourcurrent views with respect to future events and are based onassumptions and subject to risks and uncertainties. Given theseuncertainties, you should not place undue reliance on theseforward-looking statements. We discuss many of these risks in greaterdetail in our filings with the Securities and Exchange Commission.
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SOURCE: Acura Pharmaceuticals, Inc.
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