Inspirion Delivery Technologies Announces Completion of Successful Pre-IND
Meeting With The FDA On Abuse Deterrent Oxycodone ER Product

    


    
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<p>VALLEY COTTAGE, N.Y., <chron>Sept. 28</chron> /CNW/ -- Inspirion Delivery Technologies, LLC ("IDT") announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.</p>
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<p>Typical opioids provide abusers with multiple pathways to abuse, including crushing, smashing, chewing, grinding, or dissolving in alcohol or other solvents.  This tampering results in rapid and potent euphoric highs that can lead to dependence, drug craving, diversion, addiction, and fatal overdoses.  Using a unique, patented, multi-layer design, IDT's abuse deterrent technology eliminates the majority of these pathways of abuse by restricting absorption if the tablet is physically damaged.  This results in comparable blood levels when the tablet is damaged and ingested orally, as well as significantly lower levels if snorted or injected.  Additionally, the formulation does not "dose dump" in alcohol or other common solvents.  The Company's technology allows for flexibility in formulation of release profiles to achieve bio-equivalency to approved and marketed products, as well as the design of unique release profiles to offer dosing and therapeutic advantages to patients.</p>
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<p>"We are very pleased with the outcome of our Pre-IND interaction with the FDA," commented <person>Dr. Stefan Aigner</person>, CEO of IDT.  "The FDA was very supportive of our efforts to advance an abuse deterrent oxycodone product.  As a result of the feedback we received on our Pre-IND package, we believe we have clear visibility on the required pathway to submit our filing for our abuse deterrent, extended release formulation of oxycodone in a manner that will allow for significant differentiation in the product's labeling."</p>
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    ABOUT IDT, LLC
    
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<p>Inspirion Delivery Technologies is a privately held pharmaceutical company focused on developing, manufacturing, and marketing products based on its novel abuse deterrent technology platform.  The Company has a broad portfolio of pain management products in development, and its management team has significant formulation experience, as well as proven commercial expertise.  IDT's products possess characteristics that are best-in-class among abuse deterrent formulations.  Over <money>$10 billion</money> of prescription pain management products are sold annually, and there is a well-recognized unmet need for abuse deterrent products.  The Company has completed proof-of-concept in a number of in-vitro and human in-vivo studies and is actively seeking strategic partnerships to advance selected opportunities in the pain management and ADHD areas.  Visit <a href="http://www.inspirionrx.com">www.inspirionrx.com</a> for additional details.</p>
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    FORWARD LOOKING STATEMENTS
    
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<p>To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks.</p>
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For further information: Kip Martin, VP Finance & Business Development, Inspirion Delivery Technologies, LLC, [phone], [email protected] Web Site: http://www.inspirionrx.com