MATRIXX INITIATIVES CONFIRMS VOLUNTARY RECALL OF ZICAM COLD REMEDY NASAL GEL, ZICAM COLD REMEDY GEL SWABS

MATRIXX INITIATIVES CONFIRMS VOLUNTARY RECALL OF ZICAM COLD REMEDY NASAL GEL, ZICAM COLD REMEDY GEL SWABS

Company Disagrees with the FDA on Product Safety Concerns,

Continues to be Committed to Cooperating with the FDA on Resolution

SCOTTSDALE, ARIZONA – June 24, 2009 – Matrixx Initiatives, Inc. (NASDAQ: MTTX) has announced that it is in the process of formally notifying retailers, wholesalers and distributors nationwide of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs.  Matrixx Initiatives vigorously disagrees with the FDA’s allegations that these products are not safe and that they were unlawfully marketed.  However, the company reiterated that it is conducting this recall because of its desire to cooperate with the FDA.  The company is also in the process of preparing a submission to the FDA and, as previously reported, will soon ask to meet with the agency to present comprehensive scientific and medical data and analyses demonstrating that these products are safe.

Matrixx Initiatives immediately suspended shipments of these two products upon receipt of the FDA’s warning letter on June 16 and then announced a voluntary nationwide withdrawal of Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs that same day.  The company is also notifying retailers to stop selling Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs and is asking them to post information at point-of-sale, advising consumers of the recall and inviting them to return these two products to Zicam for a full refund.  A copy of the recall notification is attached.

The company also has communicated on a proactive, ongoing basis with consumers since it announced the voluntary recall of these products on June 16, 2009.  These have included full-page ads in leading newspapers, distribution of an informational video from Matrixx Initiatives’ president, updated copy for the Zicam Web site at www.zicam.com, expanding staffing of the Zicam customer support center, and extensive use of social media vehicles.

Matrixx Initiatives, Inc. is engaged in the development and marketing of over-the-counter healthcare products that utilize innovative drug delivery systems.  Zicam, LLC, its wholly owned subsidiary, markets and sells Zicam® products in the cough and cold category.  For more information regarding Matrixx products, go to www.zicam.com.   To find out more about Matrixx Initiatives, Inc. (NASDAQ: MTTX), visit our Web site at www.matrixxinc.com.

Matrixx Initiatives, Inc., the manufacturer of Zicam Cold Remedy intranasal zinc gluconate gel products, affirms that its intranasal gel products do not cause hyposmia (diminished sense of smell) or anosmia (loss of smell), and allegations to the contrary are scientifically unfounded and misleading. The company’s position is supported by the cumulative science and has been confirmed by a multi-disciplinary panel of scientists and the decisions of 10 separate federal judges evaluating scientific evidence in 10 different cases.

Although plaintiffs and their attorneys hoping for financial gain have sued Matrixx, no plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell. No well-controlled scientific study has demonstrated a potential cause-and-effect relationship between use of Zicam and diminished smell function. No court cases have revealed any reliable evidence of any causal relationship. All scientific research and all controlled scientific studies to date have shown that Zicam is not a likely cause of smell dysfunction, and all of the anecdotal speculation offered in court has been discredited as unrelated, unreliable or deeply flawed.

In randomized placebo-controlled clinical trials focusing exclusively on intranasal zinc gluconate gel, the overall incidence of side effects was extremely low, with no statistically significant difference between the adverse event rates for the treated and placebo subsets. ^{1 2}

In no clinical trial of Zicam gel has there been a single report of lost or diminished olfactory function (sense of smell).

In addition to clinical trials designed primarily to investigate product efficacy (how well the product works to reduce the severity and duration of colds due to the common cold virus, the rhinovirus) Matrixx Initiatives unconditionally funded four academic-based research studies in 2004-2005 to 1) better assess the causes of smell loss and the rate at which smell loss occurs; 2) determine whether any substantial amount of the nasal gel interacts with the smell tissue located in the very top portion of the nasal cavity; and 3) evaluate through animal experiments how much Zicam would be expected to be required for any substantial adverse effect on smell function.

The researchers who conducted the independent academic-based research studies include clinicians and university researchers. After reviewing the data, the researchers and other scientists on Matrixx Initiatives’ Scientific Advisory Board unanimously concluded that the cumulative scientific evidence failed to support the suggestion that Zicam use is associated with impairment of the senses of smell and taste. Rather, the evidence confirms that the major causes of smell loss are upper respiratory infection and nasal and sinus disease, all of which are present in the population of Zicam users. None of the Zicam gel reaches the smell tissue when Zicam is used as directed, and there is only scant and questionable evidence that even trace amounts can reach the upper nasal cavity when the product is egregiously misused. The animal experiments indicated that it would take an extraordinary overdose of Zicam reaching the smell tissue to cause even a temporary effect on smell function.

The National Institutes of Health estimates that approximately 2.5 million American adults suffer from partial or complete loss of smell, some due to the common cold, some due to sinusitis/rhinitis, some due to head trauma, others due to disease or simply aging. ^{3 4} Most experts in the field believe that figure grossly under-estimates the number of people suffering from chronic smell loss. Recent studies in Scandinavia suggest that more than 10% of the adult population suffers from chronic smell dysfunction