Study continues Reloxin's path to FDA approval: How is it different from Botox?

A study released on Monday afternoon regarding Reloxin is making headlines. Many may wonder why, since it has been discussed in the U.S. media for at least a year and has been used even longer than that in Europe as Dysport.

If you want to check out the study yourself, click here for a PDF.



Dr. Goldberg says:

"This Reloxin study is important because it represents the first published US study involving an alternative to Botox®. It should be noted that although this is the first published US study on Reloxin, this wrinkle softening agent is not new. Reloxin, called Dysport in Europe, is a very popular alternative to Botox® over there. It has been shown to be both safe and effective.

This first US study will be far from the last. We and others are currently involved in several other Reloxin trials. Many of these trials involve evaluating injections of Reloxin every few months and over the course of several years.

Reloxin will be the first US competitor to Botox®. It will not be the last. We and others are studying even more alternatives such as Mentor's Purtox and Merz's Xeomin. The future is exciting for non-invasive cosmetic treatments."

Disclaimer: we know the authors of this study very well and I am on the Reloxin advisory board.

American consumers are interested in the bottom line of this product. Other research seems to say that it has a faster onset than Botox®, and a softer look. It is a good option for using on patients with resistance to Botox®. But generally, Reloxin will be very similar to Botox® and patients should not have any different expectations.

Link:
Medicis' Reloxin May Vie with Botox in U.S. to Clear Wrinkles [Bloomberg News]

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Breaking: FDA extends review date for Reloxin

Reuters is reporting that the FDA has extended the initial review of Ipsen's botulinum Type A toxin product, Reloxin, anticipated as the first American competitor to Botox.

According to Ipsen, the FDA also confirmed that their Wales facility for manufacturing the product is in compliance with their regulations.

Dr. David Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Reloxin: Part Deux

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

Reloxin preferred over Botox in tests?

I just returned from a Pharmadura meeting in Dallas, which centered around the upcoming FDA approval for Botox competitor Reloxin. It's called Dysport in Europe and is to be distributed by Medicis in North America.

The advantages of Reloxin are its faster onset and "softer" look. Some proponents claim there is a longer lastings effect, but this is not certain at present. Anecdotal evidence from patients in the U.S. FDA trials who were Botox users are that these patients preferred Reloxin. Adverse incidents from the FDA trials are less then those experienced with the Botox trials, but his may be due to the fact that the physicians in the trials are more experienced injectors.

We await FDA approval and hope to have Reloxin for clinical use by first quarter 2009.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David Goldberg
Skin Laser & Surgery Specialists NY/NJ
Sanctuary Medical Aesthetic Center