Botox Slammed with Stronger Label Requirements and FDA Approval of Competitor

The long-awaited approval of Reloxin is now a reality, offering Botox some stiff competition in the battle against age lines and wrinkles. However, on the heels of the approval, the U.S. Food and Drug Administration (FDA) is now requiring manufacturers Allergan, Solstice Neurosciences, and Medicis to strengthen warnings on their product labels and conduct additional safety studies due to the potentially deadly risks of unapproved uses in treating certain types of muscle spasms.

Scottsdale, Arizona-based Medicis has announced that the FDA has approved Dysport, formally known as Reloxin, for the treatment of the neurological movement disorder known as cervical dystonia in adults. Cervical dystonia is the most common form of focal dystonia, and is characterized by abnormal squeezing and twisting muscle contractions in the head and neck area. Dysport is indicated for reducing the severity of abnormal head position and neck pain caused by the condition. In addition, the drug was cleared for use to temporarily improve the appearance of moderate to severe glabellar lines, or frown lines, resulting from facial muscle movements and the passage of time. Both of the applications have been approved for use in adults younger than 65 years of age. Dysport is differentiated from other marketed botulinum toxin products with the unique established name abobotulinumtoxinA.

Medicis anticipates that sales of Dysport for aesthetic applications in the U.S. will begin within 30 to 60 days. With the approval, Boulogne Billancourt, France-based Ipsen, developer of the drug, will receive a $75 million payment and will handle sales of Dysport for cervical dystonia, as early as the latter half of this year.

The market buzz is that Dysport may be priced 15 percent lower than Botox, which would allow for the newly approved drug to take almost one-third of the cosmetic market over time. Annual sales of Dysport for aesthetic uses are estimated to be $160 million by 2012.