Oxaydo 15 mg Tablet Establishes Oxycodone Bioequivalence

September 19, 2016

Results from a pharmacokinetic study of Oxaydo 15 mg tablets demonstrated bioequivalence to doses of Roxicodone (oxycodone hydrochloride).

Egalet Corp., Oxaydo’s sponsor, intends to submit the study data to FDA as part of an sNDA. The agency has previously approved 5 and 7.5 mg doses. Oxaydo is an immediate-release formulation of oxycodone HCl for acute and chronic pain where the use of an opioid analgesic is appropriate, and is designed to discourage abuse. According to Egalet, approval of the 15 mg dose could provide access to an additional 20 percent of the immediate-release oxycodone market.

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 study, six times more recreational users reported they would not take Oxaydo again compared to subjects exposed to immediate-release oxycodone. However, there is no evidence that Oxaydo has reduced abuse liability compared to immediate-release oxycodone, according to Egalet.

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