Positive phase III results for Egalet 002(oxycodone extended release) in the management of pain- Egalet

Egalet has announced positive top-line results from a Category 3 intranasal human abuse potential (HAP) study of Egalet 002(oxycodone extended release) for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The study evaluated the abuse potential of manipulated Egalet 002 compared to crushed immediate-release (IR) oxycodone through the nasal route in 46 non-dependent recreational opioid users experienced in nasal insufflation. For the primary comparison, the difference in maximum Drug Liking (Emax) between manipulated Egalet 002 was significantly lower compared to crushed IR oxycodone. This outcome was also significant for the comparison between manipulated Egalet-002 and crushed IR oxycodone.

For the secondary outcome of Take Drug Again (on a bipolar 100-point scale), the results were 69.9 for manipulated Egalet 002 (shell on), 72.4 for manipulated Egalet 002 (shell off), and 75.5 for crushed IR oxycodone; not statistically significant for either comparison. In the exploratory analysis with OxyContin, Emax Drug Liking was similar in all treatment arms: manipulated Egalet 002 (with shell on; 79.5), manipulated Egalet 002 (with shell off; 77.4), and manipulated OxyContin (76.2).

Comment: Egalet 002 was designed using a version of Egalet's proprietary Guardian Technology that contains an inner matrix and an exterior shell. This results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation, in order to deter common routes of abuse. The physical hardness of the tablet and the gelling effect of the matrix are designed to give Egalet-002 its physical and chemical abuse-deterrent characteristics.