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ARTICLE | Clinical News

Zohydro ER hydrocodone bitartrate regulatory update

July 14, 2014 7:00 AM UTC

Zogenix said it plans to submit an sNDA to FDA by October for a next-generation of pain drug Zohydro ER hydrocodone capsules designed to make it more difficult to abuse by injection or nasal administration. Next year, Zogenix also said it will to seek to amend the label of the product to include abuse deterrent claims consistent with FDA’s current draft guidance on abuse-deterrent opioids.

Zohydro, the only approved hydrocodone-only oral drug, is a twice-daily formulation that has faced significant criticism from state and federal lawmakers for its lack of abuse-deterrence technology. In its explanation for Zohydro’s approval in October, FDA said it “would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market” if Zogenix or another manufacturer is able to create a safe and effective abuse-deterrent formulation of hydrocodone. Zohydro ER uses Spheroidal Oral Drug Absorption System (SODAS) drug delivery technology from Alkermes. ...