Egalet (EGLT) Announces Positive Top-Line Data for OXAYDO vs Roxicodone

September 12, 2016 6:43 AM EDT

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Egalet Corporation (Nasdaq: EGLT) announced top-line results from a pharmacokinetic study demonstrating bioequivalence (BE) of OXAYDO (oxycodone HCl, USP) tablets CII 15 mg to Roxicodone (oxycodone hydrochloride tablets USP) 15 mg dose. The full data will be submitted to the U.S. Food and Drug Administration (FDA) as a supplemental new drug application (sNDA).

"With the demonstration of OXAYDO bioequivalence at 15 mg we can potentially offer healthcare professionals a wider range of dosage strengths adding to the previously approved 5 and 7.5 mg doses to more effectively manage patients with acute and chronic pain," said Bob Radie, chief executive officer at Egalet. "Importantly, if the sNDA is approved by the FDA, this could provide access to an additional 20 percent of the immediate-release oxycodone market. This represents an important milestone in the lifecycle management of OXAYDO."

OXAYDO is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.OXAYDO is designed to discourage intranasal abuse through its novel, patent protected formulation. The product contains an inactive ingredient that may cause nasal burning if OXAYDO is manipulated and snorted. In an intranasal human abuse potential double-blind, crossover study, six times more recreational users reported they would not take OXAYDO again compared to subjects exposed to immediate-release oxycodone (30 percent of subjects exposed to OXAYDO responded they would not take the drug again compared to five percent of subjects exposed to IR oxycodone). The clinical significance of the difference in drug liking and difference in response to taking the drug again reported in this study has not yet been established. There is no evidence that OXAYDO has reduced abuse liability compared to immediate-release oxycodone.

Study OY-EG-119 was a randomized, open-label, single dose three period cross-over study that evaluated the bioequivalence of OXAYDO 15 mg compared to Roxicodone 15 mg in 62 healthy subjects in a fasted state. The primary objective of the study was to assess bioequivalence of OXAYDO 15 mg compared to Roxicodone 15 mg. The full results will be presented at a scientific conference in the future.



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