Event – Odds stacked against Zogenix’s long-ac
Post# of 2146
Event – Odds stacked against Zogenix’s long-acting hydrocodone (Subscription Only Story)
Source: EP Vantage
Company: Zogenix, Alkermes, Pain Therapeutics
Date: May 30, 2013
The PDUFA date for Zohydro ER, an extended-release formulation of hydrocodone developed by Zogenix, is finally approaching following a delay to the decision, originally scheduled for March 1. If Zogenix is looking forward to getting an answer at last, perhaps it should not be: the verdict will almost certainly be a no.
The problem is twofold: firstly, an adcom convened in December voted overwhelmingly against Zohydro ER reaching patients, and secondly the FDA’s scrupulousness when it comes to opioid painkillers with the potential for abuse by addicts. Zogenix needs a green light to drive much needed growth - a negative decision would cause the company its own kind of pain.
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