Item 8.01 Other Events.
On May 2, 2012, Zogenix, Inc. (the "Company") submitted a New Drug Application
("NDA") to the U.S. Food and Drug Administration for Zohydro™ (hydrocodone
bitartrate extended-release capsules), the Company's lead investigational
product candidate for the treatment of chronic pain. The Company has included in
the NDA a Risk Evaluation and Mitigation Strategy (REMS), which is intended to
control inappropriate prescribing, misuse and abuse of extended-release opioids
while maintaining patient access to essential pain medications.
The NDA submission is based on data from over 1,100 patients with chronic pain
participating in the Company's pivotal Phase 3 efficacy study (Study 801) and an
open-label Phase 3 safety study (Study 802) of Zohydro. In conjunction with the
NDA submission, the Company is required to make a milestone payment of $1.0
million to Alkermes Pharma Ireland Limited ("APIL"), a subsidiary of Alkermes,
plc, under the Company's exclusive license agreement with APIL in the United
States for Zohydro.
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