Q&A: Botox Cosmetic’s FDA approval may lead to higher visibility, more patient inquiries
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Key takeaways:
- Botox Cosmetic was approved in October for the treatment of platysma bands.
- The product can be marketed directly to consumers which may increase awareness for this nonsurgical solution to platysma bands.
Healio spoke with Darin Messina, PhD, on the significance and practical impact of the FDA’s most recent approval of Botox Cosmetic for platysma bands.
As Healio previously reported, the FDA approved Botox Cosmetic (onabotulinumtoxinA, Allergan Aesthetics) to temporarily improve the appearance of moderate to severe platysma bands — vertical bands that connect the jaw and neck — in adults.
The approval made Botox Cosmetic the first neurotoxin to be approved for four indications.
Following this news, Healio spoke with Messina, who is the senior vice president of Aesthetics R&D at Allergan Aesthetics, about the details behind the approval and what this new indication means for physicians and their patients moving forward.
Healio: What makes the approval of Botox Cosmetic unique and significant?
Messina: Botox Cosmetic is the first and only neurotoxin product FDA approved to temporarily improve the appearance of moderate to severe forehead lines, frown lines, crow’s feet lines and now platysma bands in adults. No other company or country in the world has these four approved indications.
With this indication approval, we now have a proven, safe and effective platysma band treatment paradigm to leverage when training aesthetic providers through Allergan Medical Institute. The Botox Cosmetic treatment paradigm for platysma bands is tailored to patients based on severity, giving providers more options to appropriately treat their patients. With this FDA approval, we can standardize injector training for platysma bands, which helps to promote safe and optimal outcomes.
The approval also means we can market the product directly to consumers, increasing awareness for Botox Cosmetic as a viable treatment option to address visible and prominent platysma bands.
Healio: What did the phase 3 data show in the studies that supported this approval?
Messina: There were two studies that supported this approval. Both were randomized, double-blind, placebo-controlled phase 3 clinical trials (Study M21-309 [NCT04949399] and Study M21-310 [NCT04994535]) that evaluated Botox Cosmetic for the temporary improvement in the appearance of moderate to severe platysma bands from baseline vs. placebo.
Based on baseline severity, subjects were randomly assigned to receive a single treatment of Botox Cosmetic (26, 31 or 36 units) or placebo. The primary efficacy endpoint was a multi-component endpoint defined as achievement of grade 1 or 2 (minimal or mild) and at least a 2-grade improvement from baseline in platysma band severity at maximum contraction, assessed by both investigator and subject at day 14.
In these clinical studies, the primary endpoint was met, demonstrating statistical significance for the improvement in appearance of platysma bands from baseline with Botox Cosmetic vs. placebo (P < 0.0001). Primary endpoint was a multi-component 2-grade or greater improvement based on both investigator and subject assessments of platysma band severity at maximum contraction at day 14: 32% (n = 63) vs. 2% placebo (n = 4) in Study 1; 31% (n = 64) vs. 0% placebo (n = 0) in Study 2. This measure was based on both investigator and subject assessment.
All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome instruments. For example, in two clinical studies, two-thirds of patients (65% and 62%) reported being “very satisfied” or “satisfied” with the appearance of their vertical neck bands and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of Botox Cosmetic, compared with 12% in both studies with placebo.
Healio: How does onabotulinumtoxinA compare with other treatments for platysma prominence?
Messina: Until now, treatment options for moderate to severe vertical bands connecting the jaw and neck have been limited. With Botox Cosmetic’s platysma bands indication approval, there is now a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck in adults.
Reference
- BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands). Published Oct. 18, 2024. Accessed Nov. 6, 2024.
Perspective
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While Botox Cosmetic is the first neurotoxin to gain FDA approval for four aesthetic areas — forehead lines, frown lines, crow’s feet and now platysma bands — this approval doesn’t change much in practice for plastic surgeons. We have been using neuromodulators, including Botox and other similar products, for these areas off-label for years, and there are scores of published papers in the clinical database that describe the safety and efficacy of neuromodulators for the neck, so the treatment approach itself is not new.
However, what this FDA approval does bring is heightened awareness and greater patient education on platysma band treatment, an area that patients may not realize can be addressed non-surgically.
The primary impact of this approval will be more educational resources and visibility around treating platysma bands with neuromodulators, which may lead to a higher level of patient inquiries. From a practical standpoint, it will make it easier to discuss platysma band treatment with patients, as they may have greater familiarity with it as an option.
However, for experienced practitioners, it doesn't add any new treatment capability. This approval simply reinforces what we’ve known and practiced, while enhancing awareness and patient comfort with these aesthetic options.
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