=DJ Matrixx Response To Zicam Warning Letter Doesn't Satisfy FDA
Friday , November 20, 2009 15:50 ET
By Carol S. Remond
Of DOW JONES NEWSWIRES
Matrixx Initiatives Inc. (MTXX) is attempting to take the offensive in its battle with the Food and Drug Administration over the safety of its nasal cold remedy Zicam.
Four months after it received a warning letter from the FDA alleging that two of Matrixx's cold remedies may cause a loss of smell, the company has filed its official response. In a letter made public through a filing with the Securities and Exchange Commission, Matrixx said "because there is no valid scientific evidence that these Zicam products are unsafe," the FDA should withdraw its warning letter and close the matter.
But that's unlikely to happen.
An FDA spokeswoman told Dow Jones Newswires Friday the agency doesn't consider Matrixx's answer letter to be a response to its warning letter.
"In FDA's warning letter to Matrixx, we stated that we had concerns about the safety of these Zicam products and the company needed to file data demonstrating that they were safe and effective. The Zicam zinc nasal products are for the common cold--a condition which runs its course without any medication--we are especially concerned that they should not cause harm to the user," the spokeswoman said.
Matrixx said in its letter that it had been unable to engage in any meaningful discussion with the FDA. Rather than provide the data requested by FDA, it's essentially asking the agency to prove that Zicam isn't safe.
Zicam Cold Remedy intranasal products are over-the-counter common-cold medicine marketed as homeopathic drug products. Matrixx earlier this year voluntarily pulled two products off the shelves in response to the letter. Other Zicam products weren't affected by the FDA action.
In January 2004, Dow Jones Newswires first reported an FDA investigation into complaints that Zicam Cold Remedy, a spray designed to deliver a zinc gel into the nose, may cause a loss of smell in some users. Matrixx has said all along that reports linking Zicam to a loss of smell are misleading and unfounded.
Matrixx shares were recently trading at $4.35 a share, up 14%. The company stock traded around $19 a share before the FDA warning letter became public on June 16.
-By Carol S. Remond, Dow Jones Newswires; 303-997-5783; carol.remond@dowjones.com
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(END) Dow Jones Newswires
November 20, 2009 15:50 ET (20:50 GMT) |
