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.