Pharmacokinetic Study Compares Oxaydo to Roxicodone at 15mg Dose

The study was randomized, open-labeled, single dosed and 3-period cross-over
The study was randomized, open-labeled, single dosed and 3-period cross-over

Egalet announced top-line results from a pharmacokinetic study that demonstrated the bioequivalence of Oxaydo (oxycodone HCl) 15mg tablets to Roxicodone (oxycodone HCl) 15mg tablets. 

Study OY-EG-119 was a randomized, open-label, single dose 3-period cross-over study that assessed the bioequivalence of Oxaydo 15mg vs. Roxicodone 15mg (n=62) in patients in a fasted state. 

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Oxaydo, an immediate-release formulation of oxycodone HCl, is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. Oxaydo contains an inactive ingredient that causes nasal burning if it is manipulated and snorted. It is available as 5mg and 7.5mg strength tablets. 

Egalet will submit full data to the Food and Drug Administration (FDA) as a supplemental New Drug Application (sNDA). 

For more information call (800) 518-1084 or visit Oxaydo.com.

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