ARTICLE | Clinical News

Zohydro ER hydrocodone bitartrate regulatory update

October 6, 2014 7:00 AM UTC

Zogenix submitted an sNDA to FDA for a capsule formulation of Zohydro ER hydrocodone bitartrate designed to deter abuse by injection or nasal administration. The company expects a decision by FDA in 1Q15. If the sNDA is approved, Zogenix plans to begin marketing the new formulation in place of the currently marketed one beginning in 2Q15.

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 2013, 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. ...