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Atlantic Pharmaceuticals, Inc. Announces Completion of Successful Pre-IND Meeting with FDA for Abuse Deterrent Narcotic
Date:6/23/2009

ATLANTA, June 23 /PRNewswire/ -- Atlantic Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that it has completed a pre-investigational new drug (PIND) meeting with the Food and Drug Administration (FDA) for guidance on a mutually acceptable regulatory pathway for submission of an abuse deterrent immediate release oxycodone.

Atlantic's proprietary oral delivery technology Smart/Script(TM) is the basis of the abuse deterrent characteristics of the product. For the currently marketed formulations of commonly misused immediate release opioids, simple methods such as chewing, crushing and/or dissolution in water can expose the entire dose of opioid contained in the formulation, allowing it to be injected or used nasally. Tampering with the dosage form and self-administering it orally, nasally or intravenously results in a rapid rise in the blood concentration of the opioid. A rapid rise in blood concentration is more likely to result in drug liking and reinforcement and increases the abuse liability of the drug. Once a drug is loaded into Smart/Script(TM) however, it is non-extractable in common injectable solutions, non-crushable and is released when activated in the gastrointestinal system.

Anthony Soscia, President of Atlantic, stated, "We appreciate the comprehensive feedback we received from our pre-IND meeting with the FDA. This regulatory direction will assist our application process. We believe this guidance sets our NDA filing target for 2010."

The increasing misuse, abuse and diversion of opioid pain medications have become widespread and pose costly and significant public health issues. In 2005, the estimated total cost associated with opioid abuse, including health care, justice, and work-related costs, totaled $9.5 billion. Commercially, the U.S. pain market alone is currently estimated at $14.5 billion according to Global Industry Analysts, Inc.

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