October 29, 2013
The amount of government activity on issues involving controlled substances last week makes the furlough seem like a figment of our imagination. Following issuance of a press release on hydrocodone rescheduling and a court ruling on DEA’s delay on the scheduling of FYCOMPA (see prior posts here and here) on Friday, FDA announced its approval of New Drug Application (“NDA”) No. 202880 for Zogenix, Inc.’s (“Zogenix’s”) single-entity, extended-release, hydrocodone pain-killer drug, Zohydro ER. FDA’s approval renders Zohydro ER the first U.S. approved single-entity hydrocodone product, the first extended-release/long-acting (“ER/LA”) opioid analgesic to contain hydrocodone, and the first ER/LA opioid analgesic to display new labeling proposed for that class of drugs.
Although Congress placed single-entity hydrocodone in Schedule II, when it first passed the Controlled Substances Act in 1970, Zohydro ER is the first drug subject to that rule. Fortunately for Zogenix, this pre-determined schedule means that Zogenix need not wait to market Zohydro ER while DEA determines whether and in which schedule to place the drug. This is in sharp contrast to the experience of manufacturers of new chemical entities (“NCEs”) with abuse-potential, who customarily agree to refrain from marketing their products until DEA issues a final scheduling order, which can take over a year, and who may lose their exclusivity rights in the interim. (See prior posts here and here, and a challenge to FDA’s position on the start of the exclusivity clock here.)
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