Priority Review for Purdue's abuse-deterrent hydrocodone

Purdue Pharma L.P. (Stamford, Conn.) said FDA accepted and granted Priority Review to an NDA for a once-daily, abuse-deterrent formulation of hydrocodone bitartrate extended release (ER) to treat chronic pain. The PDUFA date is in October, but the specific date is not disclosed.

Zogenix Inc. (NASDAQ:ZGNX) slipped $0.27 (13%) to $1.86 on Tuesday. The company's Zohydro ER -- the only approved hydrocodone-only oral drug -- has faced significant criticism from state and federal lawmakers for its lack of abuse deterrence technology. In its explanation for Zohydro's approval, 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. ...