Reloxin Approval Put Off Again

Approval for Reloxin, a competitor for Botox, appears to have been delayed again. Reloxin, like Botox, is Botulinum Type A. It is to be marketed by Medicis, now part of Johnson & Johnson, while Botox is manufactured by Allergan. Reloxin was supposed to be approved in the summer or fall of last year, but the FDA rejected the application because they felt that Medicis had not developed sufficient plans to follow up potential side effects. The new approval date was to be this month, but the FDA has now extended the approval period until April 13.

Reloxin has been used in Europe and Canada under the name Dysport since 1991. Although it is the same chemical as Botox, it is manufactured a bit differently and has somewhat different properties. The units of Botox and Reloxin are not the same, and 1 unit of Botox probably equals 2.5-3 units of Reloxin. The products contain different quantities of protein and Reloxin diffuses further from the point of injection than does Botox. This may be a benefit when treating the hands for increased sweating, hyperhidrosis, allowing fewer injection sites, but it might present a problem when treating the forehead where muscles of eye or eyelid movement might be more frequently affected. So far, however, an increased incidence of this type of problem has not been reported in the clinical studies of Reloxin.

Gerald N. Bock MD
California Skin & Laser Center
Stockton & Lodi, CA