Egalet Corporation announces Oxaydo (oxycodone oral HCl tablets) bioequivalence study for treatment of acute and chronic pain.
Egalet Corporation 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 FDA as a supplemental new drug application (sNDA).
Comment: With the demonstration of Oxaydo bioequivalence at 15 mg the company 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. If the sNDA is approved by the FDA, this could provide access to an additional 20 percent of the immediate-release oxycodone market.
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