from: http://www.sec.gov/Archives/edgar/data/1006195/000095015304000484/0000950153-04-000484.txt -----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IpI/S1Fuarc77fF+u0v1zfTAaX+BhvAD2bknb1DWRUYd15r1+zKL6+0Wh4baKSrN Re8dZDLQe0gL5Sgu8vKsnw==0000950153-04-000484.txt : 20040227 0000950153-04-000484.hdr.sgml : 20040227 20040227155556 ACCESSION NUMBER: 0000950153-04-000484 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20040219 ITEM INFORMATION: Other events FILED AS OF DATE: 20040227 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MATRIXX INITIATIVES INC CENTRAL INDEX KEY: 0001006195 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 870482806 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31404 FILM NUMBER: 04635172 BUSINESS ADDRESS: STREET 1: 2375 EAST CAMELBACK ROAD STREET 2: SUITE 500 CITY: PHOENIX STATE: AZ ZIP: 85016 BUSINESS PHONE: 6023875353 MAIL ADDRESS: STREET 1: 2375 EAST CAMELBACK ROAD STREET 2: SUITE 500 CITY: PHOENIX STATE: AZ ZIP: 85016 FORMER COMPANY: FORMER CONFORMED NAME: GUMTECH INTERNATIONAL INC \UT\ DATE OF NAME CHANGE: 19960202 8-K 1 p68843e8vk.htm 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
February 19, 2004 (Date of earliest event reported)
MATRIXX INITIATIVES, INC.
| DELAWARE | 0-27646 | 87-0482806 | ||
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
4742 North 24th Street, Suite 455
Phoenix, Arizona 85016
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code (602) 387-5353
| ITEM 5. OTHER EVENTS | ||||||||
| SIGNATURES | ||||||||
ITEM 5. OTHER EVENTS
Matrixx Initiatives, Inc., the manufacturer of Zicam® Cold Remedy zinc products, convened a two-day meeting of a panel of physicians and scientists to review current information on smell disorders. The meeting was held in response to a poster presentation at the American Rhinological Society in September 2003 alleging an association between the use of Zicam and the onset of smell disorders.
The incidence of smell disorders in the United States is reported at 1-2% of the population. Reported post-marketing subjective complaints of distortion of sense of smell associated with Zicam are well below national levels.
In the opinion of the panel, there is insufficient scientific evidence at this time to determine if zinc gluconate, when used as recommended, affects a person’s ability to smell.
Panel members noted that upper respiratory infection is the most common cause of disorders of smell; and, therefore, any product to treat upper respiratory symptoms may be mistakenly associated with distortion of sense of smell.
The panel recommended additional animal and human studies to further characterize these post-marketing complaints. Study findings are expected to be available in 12 months.
Panel members included Lawrence DeSanto, M.D., Mayo Clinic, Scottsdale; Joseph E. Dohar, M.D., Children’s Hosital of Pittsburgh; Aiden L. Doyle, M.D., FACS, Pharmacetical Consultant, Central Nervous System; Jack M. Gwaltney Jr., M.D., University of Virginia Health System; Kathleen M. Guthrie, Ph.D., Department of Biomedical Science, Florida Atlantic University; Judith K. Jones, M.D., Ph.D., Pharmacoepidemiologist; Bao-Anh Nguyen-Khoa, Pharm. D., M.P.H., Pharmacoepidemiologist; Burton M. Slotnick, Ph.D., Department of Psychology, University of South Florida; Michael Zmuda, Ph.D., Regulatory Consultant.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MATRIXX INITIATIVES, INC. (Registrant) | ||
| /s/ William J. Hemelt | ||
| William J. Hemelt | ||
| Executive Vice President, Chief | ||
| Financial Officer, Treasurer and | ||
| Secretary |
Date: February 27, 2004