FDA Approves New Wrinkle Treatment
May 1, 2009 -- The FDA has approved Dysport to treat forehead wrinkles and frown lines, making it only the second drug to be approved by the agency as a wrinkle treatment.
Dysport (formerly known as Reloxin) is made from the same active ingredient as Botox (made by Allergan), Clostridium botulinim toxin type A. Botulinum toxins temporarily reduce the appearance of wrinkles by restricting the muscle actions that cause creasing and frown lines.
Like Botox, Dysport is administered via an injection at the site of forehead wrinkles. According to Ipsen Biopharm Ltd., which makes Dysport, the FDA based its approval on clinical trials involving about 2,900 people at 80 study sites.
One clinical trial showed 93%-95% of participants noticed an improvement in the appearance of forehead wrinkles within seven days after treatment, and multiple treatments produced effects that lasted for more than 13 months.
The most common side effects of Dysport are nose and throat irritation, headache, pain and skin reaction at the injection site, upper respiratory tract infection, eyelid swelling or drooping, sinus inflammation, and nausea.
Yesterday, the FDA also announced that it will require a black box label for all botulism-based drugs, including Dysport and Botox, warning of a rare but potentially life-threatening complication when the effects of the toxin spread from the injection site.
Ipsen has granted distribution rights for the drug’s cosmetic use to Medicis. Medicis says the wrinkle treatment should be available for use in the U.S. in the next 30 to 60 days.
Dysport will be available for the treatment of cervical dystonia in the second half of 2009.