Study showed that Egalet-002, an abuse-deterrent, extended-release oxycodone product with Guardian Technology, required more effort to manipulate than OxyContin (oxycodone hydrochloride)- Egalet Corporation,

Egalet Corporation announced positive top-line results from a study using the ALERRT instrument. The study showed that Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet's Guardian Technology, required significantly more effort to manipulate than OxyContin (oxycodone hydrochloride).

The ALERRT instrument, which uses visual analog scales, is a tool developed by PinneyAssociates, Inc. to standardize how to quantify the level of effort required to manipulate an abuse-deterrent product candidate. The study was conducted in accordance with the FDA's final Guidance for Industry, Abuse-Deterrent Opioids � Evaluation and Labeling (April, 2015), which states that "testing should provide information sufficient to fully characterize the product's abuse-deterrent properties, including the degree of effort required to bypass or defeat those properties."

Top-line results from the study include: 1. Egalet-002 was rated as moderately to extremely hard to physically manipulate (e.g., cut, crush, grind) on a tool by tool basis; 2. The order of level of effort required to manipulate, from highest to lowest, was the following: 1) Egalet-002 80 mg, 2) Egalet-002 10 mg, 3) OxyContin 40 mg and 4) Roxicodone 30 mg; 3.Based on this study using the ALERRT instrument, both Egalet-002 10 mg and 80 mg require significantly more effort to tamper as compared to both Roxicodone and OxyContin; and 4.More instruments were damaged and/or broken when manipulating Egalet-002 compared to both Roxicodone and OxyContin.