Egalet Reports Top-Line Results From Abuse Liability Study Of Egalet-002

(RTTNews) - Egalet Corp. (EGLT) reported top-line results from a Category 3 human abuse liability study of Egalet-002, an abuse-deterrent, extended-release, oral oxycodone product candidate in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

Egalet said the method of manipulation for Egalet-002 involved both mechanical and electrical instruments, as compared to both immediate-release oxycodone and OxyContin, which both required only a one-step manipulation process. The company said the Category 1 data has demonstrated that it took five times the level of effort to manipulate Egalet-002 compared to abuse-deterrent OxyContin. The results of the oral HAL study showed that, after maximal manipulation, drug liking was similar for Egalet-002, IR oxycodone and OxyContin following oral administration in nondependent recreational opioid users.

Bob Radie, CEO of Egale, said: "We believe that the inability to chew Egalet-002 sets it apart from other abuse-deterrent opioid products. We plan to discuss these results with the FDA as we design a pivotal oral HAL study for Egalet-002."