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FDA Approves Xeomin for Upper Limb Spasticity

December 23, 2015

Xeomin (incobotulinumtoxinA, Merz North America) has received FDA approval for the treatment of upper-limb spasticity (ULS) –– the abnormal head position and neck pain that occurs with cervical dystonia in adults. In clinical studies, treatment with Xeomin in adults with ULS resulted in statistically and clinically significant improvements in muscle tone.

Xeomin was first approved in August 2010 for the treatment of adults with cervical dystonia and blepharospasm.

The safety and efficacy of Xeomin were evaluated in phase III clinical studies involving more than 400 adults with ULS. The approval of Xeomin for the treatment of ULS in adults was based on results from a randomized, placebo-controlled trial in which subjects experienced significant improvements in two co-primary outcome measures: muscle tone (Ashworth Scale score) and the Investigator’s Global Impression of Change of the Primary Target Clinical Pattern (PTCP) at week 4. Both parameters showed statistical significance (P < 0.001 and P = 0.003, respectively). The trial also met a key secondary outcome measure, in which subjects with an improvement of 1 or greater on the Ashworth Scale at week 4 were classified as responders (P < 0.001).

Treatment-related adverse events were reported in 3.8% and 1.9% of subjects treated with Xeomin or placebo, respectively. The most common adverse events observed with Xeomin included seizures (3%), nasopharyngitis (2%), dry mouth (2%), and upper respiratory tract infection (2%).

Xeomin is injected into muscles. It is used to treat increased muscle stiffness in the arms of adults with ULS and blepharospasm in adults who have been treated with onabotulinumtoxinA (Botox, Allergan, Inc.).

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Merz Aesthetics Announces Primary Endpoint Met in Post-Market Clinical Study of Xeomin® Vs. Botox® for Glabellar Facial Lines

March 19, 2015

Merz Aesthetics, a division of Merz North America (US affiliate of the global Merz Pharma Group), today announced positive results from a post-market, parallel group clinical trial designed to evaluate the efficacy of Xeomin® (incobotulinumtoxinA) in the treatment of moderate to severe glabellar facial lines, when compared to Botox® Cosmetic (onabotulinumtoxinA).

“We are pleased that data from our most recent post-market study further demonstrates the efficacy of Xeomin® (incobotulinumtoxinA),” stated Jim Hartman, Vice President and Head of U.S. Aesthetics/OTC for Merz North America. “Merz remains dedicated to providing our physician partners with clinical data that they need to choose and apply the treatment options that result in desired outcomes for their patients.”

Results show that this trial met its primary efficacy endpoint, defined as ≥ 1-point improvement from baseline on the Facial Wrinkle Scale (FWS) at maximum frown, 1 month after a single treatment. Similar efficacy profiles were demonstrated between the two treatment groups at all timepoints (1, 2, 3 and 4 months post-treatment). The most common adverse events seen in both treatment groups were headache, infection and facial asymmetry.

“The results of this clinical trial offer evidence that there are multiple effective options for injectors and patients seeking a neurotoxin for aesthetic use,” said Dr. Fredric Brandt, MD, co-lead investigator and board-certified dermatologist with private practices in Manhattan and Miami. As one of the world’s foremost leaders in injectables, Dr. Brandt has spent years developing innovative methods, new injection techniques and novel uses and benefits that have gained him a reputation as a pioneer within the skincare industry.

Botulinum toxin type A is a well-established treatment for glabellar frown lines. In 2011, Xeomin® (incobotulinumtoxinA) was approved by the FDA for improvement in the appearance of moderate-to-severe glabellar frown lines with a recommended dosage of 20 units (U). Head-to-head comparison studies conducted worldwide have demonstrated that Xeomin® (incobotulinumtoxinA) and Botox® (onabotulinumtoxinA) result in comparable safety and efficacy for both cosmetic use and therapeutic uses, including blepharospasm and cervical dystonia1.

“This data is consistent with previously published head-to-head comparison studies and demonstrates that Xeomin®(incobotulinumtoxinA) and Botox® (onabotulinumtoxinA) result in similar efficacy and safety profiles for the treatment of glabellar facial lines,” stated Dr. Michael Kane, MD, co-lead investigator on the study. A board-certified plastic surgeon in private practice in Manhattan, Dr. Kane frequently lectures on topics relating to aesthetic plastic surgery and has published hundreds of papers throughout his career.

“Given the fact that this is the first large, multicenter, parallel-group study to investigate the comparable efficacy of Xeomin® (incobotulinumtoxinA) to Botox® (onabotulinumtoxinA) in the treatment of glabellar frown lines, these study results have meaningful implications for patients and physicians alike,“ stated Dr. Michael Gold, MD, FAAD. Dr. Gold was one of the study’s key investigators, enrolling and following the largest group of patients throughout the trial. In addition to his work as a board-certified dermatologist and dermatological surgeon in private practice in Nashville, Tennessee, Dr. Gold also serves as an Assistant Clinical Professor of Dermatology at the Vanderbilt University School of Medicine. He plays an integral role in the development of new pharmaceutical products and medical devices through his clinical research, and presents regularly at national and international dermatology and cosmetic meetings.

Complete analysis of the data from this clinical trial is in progress, and Merz Aesthetics looks forward to presenting study results at an upcoming scientific conference, as well as to submitting data to a peer reviewed journal.

Mariana Smith, Business Wire
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