Monday, August 16, 2010

Botox® Competitor Approved by FDA For Medical Use

Earlier this month Merz Pharmaceuticals, a North Carolina-based company, announced the FDA approval of Xeomin® (incobotulinumtoxinA). Xeomin® is a botulinum toxin type A-based drug that is used to treat patients with blepharospasm (eye spasms) or cervical dystonia (neck spasms).

A recent epidemiology study conducted in Rochester, MN, found that focal dystonia, which includes both named conditions, affects 295 million people in the United States.

Two significant studies that were conducted on patients with cervical dystonia and blepharospasm were imperative to the FDA’s decision to approve Xeomin®. Findings from additional European studies comparing Xeomin® to Botox® were also included in the data that was submitted to the FDA.

Similar to Botox® and Dysport®, Xeomin® is injected into the muscle to control spasms from the nerve. The advantage of Xeomin® is that is allows more biological activity and it doesn’t require refrigeration to preserve its integrity.

As for right now, Xeomin® is only FDA approved for medical purposes and not cosmetic. Merz Pharmaceuticals is optimistic, however, that the drug will be approved for its secondary purposed in the future.

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