Allergan Aesthetics’ BOTOX[®] (botulinum toxin type A) receives MHRA approval for the temporary improvement in the appearance of moderate to severe platysma prominence (platysma bands )[1]
PRESS RELEASE – For UK Medical and Trade Media Only
- The first and only UK approved non-surgical aesthetic neurotoxin treatment to temporarily improve the appearance of moderate to severe platysma prominence in adults seen at maximum contraction, when the severity has an important psychological impact in adult patients.1
- Since contraction of the platysma muscle is involved in expressing negative emotions, platysma prominence can misrepresent a patient's emotional state. This negatively impacts self-esteem and quality of life, besides causing an appearance of ageing.2
MARLOW, UK 23rd May 2025 - Allergan Aesthetics, an AbbVie company* (NYSE: ABBV), today announced the MHRA approval of BOTOX® for the temporary improvement in the appearance of moderate to severe platysma prominence seen at maximum contraction, when the severity has an important psychological impact in adult patients.1
"This is an extremely important time with the approval of moderate to severe platysma prominence treatment with BOTOX®,” said Dr Nestor Demosthenous, Aesthetic Physician. “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.”
"This is an extremely important time with the approval of moderate to severe platysma prominence treatment with BOTOX®,” said Dr Nestor Demosthenous, Aesthetic Physician. “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.”
Djamshid Ghavami, UK&I General Manager at Allergan Aesthetics, said: “At Allergan Aesthetics, our purpose is to empower confidence, creating the products and technologies that drive the advancement of aesthetic medicine. This new indication is a testament to this purpose. Evolving what’s possible in aesthetics and meeting an unmet need for adult patients by introducing the first non-surgical neurotoxin treatment option for platysma bands in the neck and lower face area.”
†52% of UK patients (n=50).
-ENDS-
NOTES TO EDITORS:
About Platysma Prominence
The platysma muscle is a thin muscle that covers the neck and extends over the lower face. When this muscle is contracted it can cause the appearance of bands on the neck, which can also create a less defined jawline. Since contraction of the platysma muscle is involved in expressing negative emotions, platysma prominence can misrepresent a patient's emotional state. This negatively impacts self-esteem and quality of life, besides causing an appearance of ageing.2 BOTOX® achieves its effect in reducing muscle contraction in Platysma Prominence.1
About BOTOX® (Botulinum toxin type A)1
The active constituent in BOTOX® is a protein complex derived from Clostridium botulinum. The protein consists of type A neurotoxin and several other proteins. Clostridium botulinum toxin type A neurotoxin complex blocks peripheral acetyl choline release at presynaptic cholinergic nerve terminals. Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan Units are different from other botulinum toxin preparations.
About Platysma Prominence Clinical Study programme
A total of 748 subjects with moderate to severe platysma prominence at maximum contraction, who were psychologically impacted by their platysma prominence, were included in the clinical studies (N=367, Study M21-309; N=381, Study M21-310).
Efficacy
Improvements in platysma prominence severity at maximum contraction were greater for BOTOX® compared to placebo at Day 14 (p<0.0001) and at all subsequent timepoints through Day 120 (end of study) in both Study M21-309 and Study M21-310. This was measured by the proportion of subjects achieving a ≥ 2-grade improvement from baseline based on investigator and subject assessments.1
All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments.1,4
Safety
In the Phase III clinical study,4 botulinum toxin type A was well tolerated and showed a similar safety profile to its other aesthetic indications. No new safety concerns were identified, with no participant required to discontinue treatment due to adverse events.
In treatment cycle 1 of clinical trials for platysma prominence seen at maximum contraction, adverse events considered by investigators to be related to BOTOX® were reported in 4.7% of patients treated with 26 Units, 31 Units, or 36 Units, compared to 5.0% of patients who received placebo.1
The safety of BOTOX® was evaluated in the double-blind, placebo-controlled clinical studies for the improvement of platysma prominence. No adverse reactions were reported by ≥1% of botulinum toxin type A treated subjects that were also more frequent than in placebo-treated subjects.1
The safety of up to 4 BOTOX® treatments for platysma prominence was also assessed. Eligible subjects who received BOTOX® or placebo in the lead-in double-blind, placebo-controlled study received up to 3 additional BOTOX® treatments in its open-label extension study. The following adverse reactions were reported during open-label treatment of platysma prominence.1
| System Organ Class | Preferred Term | Frequency |
| Gastrointestinal disorders | Dysphagia | Uncommon |
| Nervous System disorders | Facial paresis | Uncommon |
*About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring and skin care. Our purpose is to empower confidence, creating the products and technologies that drive the advancement of aesthetic medicine. For more information, visit www.allerganaesthetics.co.uk.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk.
References:
- Medicines and Healthcare products Regulatory Agency (MHRA) BOTOX 100 Allergan Units Powder for solution for injection – summary of product characteristics (SmPC). May 2025
- Michaud, T. et al. Facial dynamics and emotional expressions in facial aging treatments J Cosmet Dermatol. 2015; 14:9-21
- AbbVie Data on File. REF-127918. Platysma Bands Global Assessment – Patient quantitative research. August 2024.
- Fabi S. et al. Improvement of platysma prominence with onabotulinumtoxinA: Safety and efficacy results from a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. February 2025.
UK Media Contacts
Cheryl Pitcher
Allergan Aesthetics, an AbbVie company
T: +44 (0) 7500 786 466
E: cheryl.pitcher@abbvie.com