ATLANTA Recently completed phase III data on Reloxin, a botulinum toxin type A formulation known as Dysport in Europe, may hasten the product's availability in the United States, Gary Monheit, M.D., said at the annual meeting of the American Society for Dermatologic Surgery and the American College of Mohs Micrographic Surgery and Cutaneous Oncology.
The new data on this "other Botox" have not been released, but Dr. Monheit described his experience with patients involved in the trial.
In a phase II trial in the United States, Reloxin was shown to be safe and effective at 30 days' follow-up. The phase III trial included 300 patients and tracked safety and efficacy for at least 5 months, he said.
The product had an excellent safety profile in both trials, and in some patients has an early onset of action, compared with Botox (Allergan Inc.), he said, noting that results were often seen in his patients in days rather than weeks.
"There was a very smooth, natural elimination of frown lines, a significant number of responders at 4 months, and action was still noted in a significant number of patients at up to 6 months," explained Dr. Monheit, an investigator for Ipsen Pharmaceuticals Ltd., the product's manufacturer, and Inamed Corp., which will develop and market the product in the United States.
Younger patients with significant frown lines had excellent results with full correction, and with very early onsetmany within 24 hours. Furthermore, some had full response well beyond 4 months, he reported. Likewise, forehead and brow response was good at 4 monthsand often well beyond that.
Older patients tended to take longer to respond, and some did not achieve the response that was expected. This might have been because of redundant skin, photodamage, or delayed or incomplete muscle response, Dr. Monheit speculated.
In a repeat-dose study that is now underway, investigators are evaluating whether repeat doses are as potent as the initial dose. A total of 1,200 patients are enrolled in the study and will be followed for 1 year, he said, noting that this will be the largest trial to date for the botulinum toxin.
Reloxin is identical to Botox except in its preparation. For example, Reloxin is provided in 500-unit vials, and Botox is provided in 100-unit vials; moreover, Reloxin is suspended in lactose, whereas Botox is suspended is sodium chloride, explained Dr. Monheit, of the department of dermatology at the University of Alabama at Birmingham, and president of the American Association for Dermatologic Surgery.
Given the differences in how Reloxin is prepared and in its onset and duration, it will likely require unique and individualized dosing and injection techniques, Dr. Monheit said.
Patient is shown at baseline in a "maximal frown" pose.
Smoothing is evident after treatment with Reloxin. Photos courtesy Dr. Gary Monheit