Egalet Reports Positive Top-Line Results From Category 1 Abuse Deterrence Studies Demonstrating Egalet-001 Resists Physical And Chemical Manipulation

WAYNE, Pa., July 15, 2014 (GLOBE NEWSWIRE) -- Egalet Corporation (Nasdaq:EGLT) ("Egalet") today announced positive results from the Category 1 abuse deterrence study for Egalet-001, an abuse-deterrent, extended-release, oral morphine-based product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The purpose of this study was to perform a comprehensive, laboratory assessment of physical and chemical manipulation of Egalet-001 and MS Contin® (morphine sulfate controlled-release) ("MS Contin") based on Category 1 guidelines presented in the Food and Drug Administration's ("FDA") 2013 draft guidance.

In the study Egalet-001 demonstrated resistance to common forms of physical and chemical manipulation as compared to MS Contin. Egalet-001 resisted crushing in order to swallow, snort or smoke, and dissolving in order to inject which is one of the most common methods of abuse of morphine-based products. Egalet-001 displayed extreme resistance to crushing and grinding with all household tools used in the study, whereas the comparator was easily converted to a fine powder. Pre-treatment of Egalet-001 by thermal stressing did not alter its resistance to physical manipulation attempts. Egalet tablets resisted all extraction attempts and maintained extended release characteristics throughout the studies. Extreme gelling of Egalet-001 occurred with all aqueous solvents, indicating Egalet-001 will not be injectable.

"The study supports Egalet-001's strong abuse-deterrent characteristics including, importantly, preventing the ability of the active pharmaceutical ingredient from being drawn into a syringe to be injected which is one of the most common methods of morphine abuse," said Edward J. Cone, Ph.D., Principal Scientist, Drug Delivery and Abuse Deterrent Drug Products, Pinney Associates. "With prescription medication abuse as the number one cause of accidental death in the U.S., it is critical that we have prescription medicines that deter abuse and Egalet-001 demonstrates real promise to help fill that need."

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