New Efficacy Results and Compliance With FDA Claims
12 September 2007
Advitech Inc. announced today that a post-marketing study conducted on patients suffering from psoriasis shows that the use of Dermylex™ may benefit patients already using topical corticosteroids. Using Dermylex with topical corticosteroids may create a synergistic effect and improve overall treatment efficacy results. Therefore, Dermylex might act as an adjuvant to topical corticosteroids.
"This new data provides Advitech and its commercial partners with important information on treatment strategies and alternatives. Adding Dermylex to a topical corticosteroid treatment appears to reduce psoriasis severity," stated Dr Christina Juneau, Advitech's Vice-President of Research and Development. "Advitech will continue to gather and monitor additional data and results from this post-marketing study in order to develop therapeutic strategies for Dermylex users."
These observations arise from a study by Advitech in which Dermylex users were invited to provide their own evaluation and comment on the results obtained with Dermylex whether taken alone or part of a concomitant treatment for psoriasis. In the questionnaire, psoriasis severity was quantified by means of an intensity scale.
ADVITECH RECEIVES CONFIRMATION FROM FDA THAT DERMYLEX CLAIMS MEET US REGULATIONS
Advitech had submitted to the US Food and Drug Administration (FDA), in June of this year, four different structure/function claims in relation to Dermylex and recently received confirmation by FDA's Division of Dietary Supplement Programs that all four claims are acceptable under the agency's regulations. These claims will be used for labeling purpose in the commercialization of Dermylex™ by Advitech’s partner in the US market.
"Regulations applicable to the US market are strict as they relate to the labeling of products like Dermylex™. This confirmation from the FDA is important for Advitech and its marketing partners as it will help position Dermylex™ in this strategic market," added Dr Juneau.
