Botox Slammed with Stronger Label Requirements and FDA Approval of Competitor
Published: Friday, 1 May 2009
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.
Jonah Shacknai, Chairman and Chief Executive Officer of Medicis stated, “We are extremely pleased to announce FDA's approval of Dysport. Medicis and Ipsen have been diligent in efforts with FDA to achieve this goal.” Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen, said, “Today marks a major strategic milestone in our history, being now in a position to effectively market four products in the U.S., whilst benefiting from Medicis' presence in the fast-growing aesthetic market.”
However, right in step with the approval of Dysport, health officials issued a warning to both doctors and patients regarding potentially fatal risks associated with the use of botulin-based drugs including Dysport and Botox as well as other similar drugs for unapproved treatments of certain types of muscle spasms. The FDA warned that Botox and two other injections have been associated with rare botulism symptoms, predominantly when administered to children for relaxing uncontrollable muscle movements. Because of this, the FDA is now requiring Botox, Myobloc and Dysport to carry a boxed warning, the most serious type of label warning the agency enforces.
The new labeling appeals to physicians to inform patients about the risks of botulin-based drugs and instruct them to seek medical care should they develop any symptoms. In addition, the drug companies will be required to develop medication pamphlets that explain the risks to patients.
Botox and similar products are being used for more than just smoothing wrinkles by paralyzing facial muscles. The drugs are also commonly being used to treat muscle-spasm conditions. In rare cases, the toxin may spread beyond the injection site into other areas of the body, causing paralysis or weakening of muscles used to breath and swallow, becoming a potentially fatal side effect.
Signs of botulism that have been reported within hours of receiving an injection of botulin-based drugs include difficulty swallowing or breathing, slurred speech and muscle weakness. The FDA has received reports of hospitalization and even death of children with cerebral palsy who are given the drugs to reduce spasticity in their legs although the drugs are not approved for such uses within the U.S. Some adult patients have required hospitalization and the use of mechanical ventilation in order to breathe after receiving the drugs as treatment of muscle spasms or for the approved treatment of cervical dystonia. Although the FDA has received reports of botulism symptoms in patients taking the drug for aesthetic applications, there has been no confirmation of these cases.
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