I am one of the U.S. investigators performing FDA studies on Reloxin. The stuff works and is safe. The distributor of Reloxin (Medicis) is doing things the right way. We have been following Reloxin patients – and re-treating them – for 3 years. This wrinkle softening material will do exactly what it has done in Europe as Dysport. It will give both patients and their physicians another wonderful choice in the fight against wrinkles.
According to Colin Stewart at the OC Register's In Your Face blog, Medicis' application to the FDA is essentially the same as the one that was rejected just 11 months ago, but has cleared up issues regarding Medicis' "sponsorship and ownership of the filing."
Dr. David Goldberg
Sanctuary Medical Aesthetic Center
Skin and Laser Surgery Specialists of NY/NJ
While I agree that Reloxin is safe and effective and will be a useful addition for our cosmetic patients, what needs to be scientifically evaluated is its benefits, if any, over Botox. The "claim" for an earlier onset of action comes purely from patient diaries and not from physician evaluation. Until a "real" scientific study is performed, I do not believe that physicians can make that claim. As a physioian who has also participated in the Reloxin trial, I too have seen this "early onset" effect and I agree with my friends, Drs. Goldberg and Pozner.
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