Egalet announced positive top-line results from a phase 3 study evaluating the efficacy and safety of Egalet-002, an abuse-deterrent, extended-release oxycodone developed using a unique application of the Guardian Technology. This second of two Phase 3 studies was a multicenter, double-blind, enriched enrollment, randomized withdrawal, efficacy and safety study of Egalet-002 versus placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back pain.
The study met its primary endpoint, which showed a statistically significant difference in average pain intensity from baseline (at randomization) to week 16 between the Egalet-002 and placebo treatment groups (p<0.0001). In a previously announced Phase 3 safety study, Egalet-002 was generally well-tolerated and no new safety concerns were identified in this study.
"These results demonstrate Egalet-002, an abuse-deterrent, extended-release oxycodone, provided effective pain relief for patients with moderate-to-severe chronic back pain," said Bob Radie, president and chief executive officer of Egalet. "Given the prevalence of chronic back pain combined with the prescription abuse epidemic, we believe development of more abuse-deterrent products like Egalet-002 is important for our communities."
Egalet's Guardian Technology has many applications and has been used to develop abuse-deterrent forms of commonly abused prescription medications. Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well characterized manufacturing process of injection molding, which results in tablets that are hard and difficult to manipulate for misuse and abuse. This approach offers the ability to design tablets with controlled-release profiles as well as physical and chemical properties that have been demonstrated to resist both common and rigorous methods of manipulation. Tablets manufactured with Guardian Technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking, using a variety of mechanical and electrical tools. They are also resistant to chemical manipulation and attempts at extraction and turn into a viscous hydrogel on contact with liquid, making syringeability very difficult.