Egalet Corporation, a fully integrated specialty pharmaceutical company, has announced the submission of a prior approval supplement (PAS) for Oxaydo (oxycodone HCl, USP) tablets C-II, seeking approval of 10 mg and 15 mg dosage strengths, has been accepted for filing by the US Food and Drug Administration (FDA). The submission is based on a pharmacokinetic study demonstrating bioequivalence (BE) of Oxaydo to its reference drug, Roxicodone (oxycodone hydrochloride tablets USP) at the 15 mg dosage strength.
"With the growing need for medications that are designed to discourage abuse, Egalet is committed to providing healthcare professionals with medications in a range of clinically relevant dosage strengths to enable them to effectively manage their patients living with acute and chronic pain," said Jeffrey Dayno, chief medical officer at Egalet. "This PAS marks an important step in the continuedlife cycle 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, initially approved in December 2015 in 5 mg and 7.5 mg dosage strengths, is designed to discourage intranasal abuse. Through its novel, patent protected formulation, Oxaydo contains an inactive ingredient that may cause nasal burning if Oxaydo is manipulated and snorted. There is no evidence that Oxaydo has reduced abuse liability compared to immediate-release oxycodone.
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has three approved products: ARYMO ER (morphine sulfate) extended-release tablets for oral use only –CII, developed using Egalet's proprietary Guardian Technology, Oxaydo (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX (ketorolac tromethamine) Nasal Spray.
Using Guardian Technology Egalet is developing a pipeline of clinical-stage, product candidates including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles.
Egalet announces us fda accepts prior approval, supplement filing, oxaydo tablets, dosage strengths
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