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     430  0 Kommentare Acura Pharmaceuticals Submits Formal Dispute Resolution Request With FDA Regarding Hydrocodone Bitartrate With Acetaminophen Tablets

    PALATINE, IL--(Marketwired - Sep 15, 2014) - Acura Pharmaceuticals Inc. (NASDAQ: ACUR), announced today that it has submitted a formal dispute resolution request with the FDA for Vycavert®, its abuse deterrent formulation of hydrocodone and acetaminophen tablets. The dispute pertains to the FDA's determination that nasal snorting abuse of hydrocodone with acetaminophen products lacks relevance.

    By taking this action, Acura is availing itself of the FDA's established appeal process whereby disagreements with conclusions reached by a reviewing Division within the FDA are reviewed above the Division level. FDA guidance stipulates that the FDA respond within 30 days.

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    Acura believes the available data, as contained in the multiple sources provided to the FDA, strongly supports the conclusion that hydrocodone containing products are known to be abused through snorting, a standard explicitly identified in FDA's January 2013 "Guidance for Industry Abuse-Deterrent Opioids -- Evaluation and Labeling". Acura further believes that such route of abuse results in hospitalizations and poses a significant public health issue. 

    Bob Jones, Acura's CEO, stated "There are critical public health policy issues being established by FDA with this decision which we believe need further discussion. Hydrocodone containing drugs are widely considered to be our most abused pharmaceutical products and 2.8% of our youths aged 12 to 17 used psychotherapeutic drugs nonmedically in 2012."

    There can be no assurance that the dispute resolution will be successful. Even if the Company were to succeed in such proceeding, in order to continue the development of our Vycavert® product we will be required to conduct an additional abuse liability study that will need to demonstrate a statistically significant reduction in Drug Liking, of which no assurance can be provided.

    About Acura Pharmaceuticals
    Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX™ contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION® contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages. IMPEDE® is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.

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    Verfasst von Marketwired
    Acura Pharmaceuticals Submits Formal Dispute Resolution Request With FDA Regarding Hydrocodone Bitartrate With Acetaminophen Tablets PALATINE, IL--(Marketwired - Sep 15, 2014) - Acura Pharmaceuticals Inc. (NASDAQ: ACUR), announced today that it has submitted a formal dispute resolution request with the FDA for Vycavert®, its abuse deterrent formulation of hydrocodone and …

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