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Scioderm's SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
Date:4/29/2013

ion conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. The FDA also has an organizational commitment to involve senior management in such guidance.

The FDA Breakthrough Therapy Designation for SD-101 in EB patents was based on clinical data from a previously conducted open-label Phase II study with topical administration of SD-101 in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  SD-101 has the potential to facilitate the healing of skin lesions and erosions in this serious and potentially life-threatening disease which has a poor prognosis.

Epidermolysis Bullosa

Epidermolysis Bullosa (EB) is a rare genetic connective tissue condition that, in all of its forms, share the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma.  This particular manifestation has led to EB patients being known as "Butterfly children" due to the analogous nature of the fragility of the skin to the wings of a butterfly.  As of today there is no cure or effective treatment.  Daily wound care, pain management and preventative bandaging are the only options available for caregivers, who are usually the parents or other family members.  The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30. 

About SD-101

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes.  An open-label Phase II study was conducted previously in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  The primary outcome measurements were assessment of target wound reduction and closure, and reduction in body surface area (BSA) coverage of lesions and erosions.  In the clinic
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Related medicine technology :

1. Scioderm Announces Positive Phase II Data of Topical SD-101 on Wound Closure and Reduction of Lesions and Blisters in Children with Epidermolysis Bullosa (EB)
2. Scioderms Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
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