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Re: Epidermal Lipids
dm0923 Views: 2,305
Published: 15 years ago
This is a reply to # 729,905

Re: Epidermal Lipids

Hey. Great find! Even if this product remains unavailable for a while, it provides an avenue for further investigation. It appears that the product you found works, not through some drug mode of action, but instead by forming a physical barrier (one that is made of epidermal lipids). Here's an article talking about the drug:

"DENVER, May 23, 2005 (PRIMEZONE) -- OnSource Corporation (OTCBB:OSCE), d/b/a Ceragenix Pharmaceuticals ("Ceragenix" or the "Company"), has withdrawn its pending Request for Designation from the United States Food and Drug Administration's Office of Combination Products ("OCP") and is meeting with OCP to discuss a proposed formulation change to its Epiceram(TM) product on June 8, 2005.
The Company believes that certain botanical ingredients may be perceived by the OCP as possessing a drug mode of action and, as a result, will be removed from Epiceram(TM), clarifying that the product's efficacy is achieved through the creation of a physical barrier on the surface of the skin. The botanicals perform a secondary mode of action that is not material to the efficacy of the product. The Company will file a new 510k for the reformulated version if OCP agrees with this analysis.
"Our overriding goal at Ceragenix is to relieve the suffering of atopic dermatitis sufferers by bringing an effective, non-steroidal product to the market," said Steven Porter, Chairman and Chief Executive Officer. "We believe this minor change to our formulation will strengthen our application for FDA clearance as a device and accelerate commercialization of Epiceram(TM)."

The Company can neither guarantee that the OCP will agree with the Company's analysis or that the Company will not experience delays in the filing of a 510k for its reformulated version, or that the FDA will timely review and approve the revised product as a device with the requested indications for use. For additional information regarding the risks associated with the development of our prescription products, investors are referred to the Company's Current Report filed on Form 8-K on May 16, 2005.

Barrier Repair Technology (US Patent 5,643,899) is based on the discovery that the lack of a competent skin barrier function plays an important role in various skin diseases including atopic dermatitis (eczema), allergic contact dermatitis and ichthyosis and that the restoration of the skin's barrier by topically applying epidermal lipids is able to significantly improve the dry skin and itching that characterizes these conditions. Atopic dermatitis, a red, scaly and itchy skin disease, is the leading childhood skin disease. New therapies for atopic dermatitis are of special importance given the recent concerns raised over the potential adverse side effects associated with Protopic(R) and Elidel(R), two popular eczema creams that the FDA Pediatric Advisory Panel recently recommended that black box warnings be added to the labels regarding potential risk of the development of cancer from use of those immunosuppressive therapies. Epiceram(TM) is steroid-free and does not contain any immunosuppressant drugs."


Thanks again <=)

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