SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 30, 2012
(Exact Name of Registrant as Specified in its Charter)
Registrants telephone number, including area code: (858) 259-1165
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Item 8.01 Other Events.
On May 30, 2012, Zogenix, Inc. (the Company or Zogenix) submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (the FDA) for Relday, which is a combination of the Companys DosePro® needle-free, subcutaneous drug delivery system plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. Initial clinical trials are currently planned to begin in the second half of the year, with results expected by year-end.
Zogenix cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as believes, anticipates, plans, expects, indicates, will, intends, potential, suggests, assuming, designed and similar expressions are intended to identify forward-looking statements. These statements are based on the Companys current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, clinical trials for Relday and the timing of the results of such trials. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Zogenixs business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as Relday, including the timing and outcome of the FDAs review of the IND for Relday; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; and other risks described in Zogenixs filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.