BOTOX® Gains MHRA Approval for Treatment of Platysma Prominence

Allergan Aesthetics, an AbbVie company, has announced a new milestone for its flagship product, BOTOX® (botulinum toxin type A), following approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The neurotoxin has received regulatory approval for the temporary improvement in the appearance of moderate to severe platysma prominence (platysma bands) in adult patients.

This approval positions BOTOX® as the first and only non-surgical aesthetic treatment approved in the UK to target platysma bands—those vertical lines that become visible in the neck during muscle contraction. The indication is specifically approved for cases where the severity of the prominence has a notable psychological impact on the patient.

Addressing an Underserved Aesthetic Concern

The platysma muscle plays a key role in facial expressions, especially those associated with negative emotions. As a result, prominent platysma bands can inadvertently convey negative expressions, such as anger or sadness, even when the individual is at emotional rest. This misrepresentation may affect self-esteem, lead to lowered confidence, and contribute to the perception of ageing.

According to Dr Maria Christidou of Allergan Aesthetics UK&I Medical Affairs, patient demand for treatment in the neck area is high. “Research shows us that over half of UK patients interviewed would be most likely to get treatment for their neck area, should a non-surgical option become available,” she stated.

A Clinically Backed, Non-Surgical Option

BOTOX® has long been established as a gold standard in non-surgical facial aesthetics, and this new approval further expands its scope. The treatment allows aesthetic practitioners to address platysma prominence effectively, using a proven injectable option that avoids surgery.

Dr Nestor Demosthenous, Aesthetic Physician, emphasised the significance of the development:
“This allows us to effectively treat a new concern non-surgically, which patients have been wanting for years, backed by strong scientific evidence and MHRA approval. This has the potential to benefit patients psychologically as it addresses an area which has been of great concern for patients.”

A Step Forward for Aesthetic Medicine

This latest approval underlines Allergan Aesthetics’ continued commitment to innovation in aesthetic medicine.
“At Allergan Aesthetics, our purpose is to empower confidence,” said Djamshid Ghavami, UK&I General Manager. “This new indication is a testament to that purpose—evolving what’s possible in aesthetics and meeting an unmet need for adult patients.”

The introduction of a regulated, non-surgical solution for treating vertical neck bands offers clinicians a new dimension in lower face and neck rejuvenation, expanding treatment possibilities for both existing and new aesthetic patients.

Backed by Robust Clinical Evidence

The MHRA approval of BOTOX® for platysma prominence is supported by a comprehensive Phase III clinical trial programme involving 748 adult subjects across two pivotal studies—Study M21-309 and Study M21-310. All participants had moderate to severe platysma prominence visible at maximum contraction, with documented psychological impact resulting from the condition¹.

Proven Efficacy

Both studies demonstrated that BOTOX® delivered statistically significant improvements in the appearance of platysma prominence compared to placebo, with results evident as early as Day 14 and sustained through Day 120 (end of study).
Efficacy was measured using both clinician and patient ratings, with a ≥2-grade improvement from baseline serving as the benchmark for success. In both studies, BOTOX® significantly outperformed placebo (p<0.0001) at every time point assessed².

All secondary endpoints were also met, including improvements reported via multiple validated patient-reported outcome (PRO) instruments, underscoring the psychological and aesthetic benefits of the treatment².

Established Safety Profile

BOTOX® was well tolerated across both trials, maintaining a safety profile consistent with its other approved aesthetic indications¹.

• No new safety concerns were identified.

• No participants discontinued treatment due to adverse events.

• In Cycle 1, only 4.7% of patients reported adverse events potentially related to BOTOX®, compared to 5.0% in the placebo group¹.

In an open-label extension phase, participants received up to four treatment cycles. Even with repeated use, no adverse reactions occurred in ≥1% of subjects that were more frequent than those observed in the placebo group¹.

This data further reinforces the reliability and safety of BOTOX® as a treatment for platysma prominence, offering reassurance to both practitioners and patients exploring this newly approved option.

To learn more about the new BOTOX® indication and its clinical implications, visit Allergan Aesthetics.

This article is intended for healthcare professionals and individuals interested in medical aesthetics.

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