DESTIN, FLA. Approval of Reloxin, a botulinum toxin type A product marketed in Europe as Dysport, is expected in the United States within the next 8-12 months, Dr. Patricia Farris said at a meeting sponsored by the Alabama Dermatology Society.
The product, which is similar to Botox, has been proved safe and effective in various trials worldwide, including in recently completed phase III U.S. trials, she said.
"The phase III clinical trial data for Reloxin in this country have not all been collated at this point, but I thank [Medicis Pharmaceutical Corp.] for sharing a little bit of it with me," said Dr. Farris, referring to the company that will develop and market Reloxin in the United States and which sponsored her talk at the meeting.
The 150-day, double-blind, placebo-controlled trial, which was designed to determine the efficacy of a single 50-unit dose for the treatment of glabellar lines, involved 300 patients. Response at 30 days in the 200 patients treated with Reloxin was excellent. "Slightly less than 90% of treated patients, compared with 0% of placebo patients, responded," said Dr. Farris of the department of dermatology at Tulane University, New Orleans.
Patients were considered responders if they improved from a score of 2 or 3 to a score of 0 or 1 on a 4-point scale, with 0 indicating no frown lines, 1 indicating mild frown lines, 2 indicating moderate frown lines, and 3 indicating severe frown lines.
Investigators used a 5-point injection technique, with two 10-unit injections in each of the corrugator muscles, and a single 10-unit injection in the procerus muscle. The 50-unit dose was shown in previous studies to be optimal. Median time to onset was 2 days, and by day 7 about 80% of patients had responded. Median duration was 117 days, Dr. Farris noted.
The product also proved to be safe. The most common adverse event was headache, and there were some ocular events, including two cases of probable Reloxin-related ptosis, she said.