ARTICLE | Company News

Zogenix submits sNDA for abuse-deterrent Zohydro

October 2, 2014 2:57 AM UTC

Zogenix Inc. (NASDAQ:ZGNX) submitted an sNDA to FDA for a capsule formulation of Zohydro ER hydrocodone bitartate designed to deter abuse by injection or nasal administration.

Zohydro, the lone approved hydrocodone-only oral drug, has faced criticism from lawmakers for its lack of abuse deterrence technology. The company expects a decision on the new formulation 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. ...