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FDA Grants Marketing Clearance for New Formulation of Fluorouracil

FDA Grants Marketing Clearance for New Formulation of Fluorouracil

The US Food and Drug Administration (FDA) recently granted marketing clearance for a new formulation of fluorouracil (5-FU) as treatment of actinic keratoses. This "Microsponge" formulation of the antimetabolite, manufactured by Advanced Polymer Systems, Inc, has demonstrated efficacy in achieving clearance of actinic keratoses in phase III clinical studies involving 384 patients. The product will initially be marketed in the United States by Dermik Laboratories, an Aventis company. A New Drug Application (NDA) was filed by Dermik in the fourth quarter of 1999.

Effective Treatment of Serious Skin Conditions

"Through initial use in Retin-A Micro for the treatment of acne, and now in 5-FU, we have demonstrated the use of the Microsponge system in delivering highly effective therapeutic treatments for serious skin conditions," said Michael P. J. O’Connell, president and chief executive officer of Advanced Polymer Systems, Inc.

The patented Microsponge system consists of porous polymeric microspheres that are loaded with an active ingredient such as 5-FU. The particles are dispersed in a cream and hold the active ingredient until applied to the skin. This permits the design of unique therapeutic formulations. The safety of the Microsponge systems has been well established, and they are used in several over-the-counter drug and skin care products besides the two prescription products, Retin-A Micro and the new 5-FU product.

"Our research and development efforts are moving toward establishing new pharmaceutical collaborations and developing additional product applications with partners for our new oral and bioerodible polymer delivery systems for use in broader pharmaceutical markets," said Mr. O’Connell.

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