UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ---------------------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 28, 2005 Critical Therapeutics, Inc. (Exact Name of Registrant as Specified in Charter) Delaware 000-50767 04-3523569 (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 60 Westview Street, Lexington, Massachusetts 02421 (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (781) 402-5700 Not applicable (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): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01. Other Events. On September 28, 2005, Critical Therapeutics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") approved the Company's supplemental New Drug Application to manufacture and market ZYFLO(R) (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of age and older. The full text of the Company's press release announcing FDA approval is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Item 9.01. Financial Statements and Exhibits. (d) Exhibits. See Exhibit Index attached hereto. SIGNATURE 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. Date: September 28, 2005 CRITICAL THERAPEUTICS, INC. By: /s/ Trevor Phillips --------------------------------------- Trevor Phillips, Ph.D. Chief Operating Officer and Senior Vice President of Operations EXHIBIT INDEX Exhibit No. Description ----------- ---------------- 99.1 Press Release dated September 28, 2005.