ARTICLE | Company News
Zogenix planning abuse-deterrent Zohydro sNDA
July 3, 2014 12:43 AM UTC
Zogenix Inc. (NASDAQ:ZGNX) jumped $0.37 (19%) to $2.36 on Wednesday after announcing plans to submit an sNDA to FDA in 2015 for a next-generation formulation of Zohydro ER hydrocodone capsules designed to be more difficult to abuse by injection or nasal administration.
Zohydro, the only approved hydrocodone-only oral drug, is a twice-daily formulation that has faced criticism from lawmakers for its lack of abuse deterrence technology. In its explanation for Zohydro's approval in October, FDA said it would "give serious consideration to assuring that any non-abuse formulations are removed from the market" if Zogenix or other manufacturers create a safe and effective abuse-deterrent formulation of hydrocodone. ...