- The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow’s Feet Lines, and Now Platysma Bands in Adults1-5
- With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in Adults1-5
IRVINE, CA, USA I October 18, 2024 I Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.1 BOTOX® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow’s feet lines, and now platysma bands, making it the first product of its kind to go beyond the face.1-5
“Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands.6* Until now, treatment options have been limited and with this approval, there is a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck,” said Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics. “This fourth indication for BOTOX® Cosmetic represents true innovation. We’re excited to open new doors for patients and providers, helping them to achieve their aesthetic goals.”
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. Treatment with BOTOX® Cosmetic works beneath the surface to temporarily reduce the underlying muscle activity and improves the appearance of the bands connecting the neck and jaw.1 By injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of BOTOX® Cosmetic based on severity—26, 31, or 36 units—BOTOX® Cosmetic temporarily reduces underlying muscle activity.1 Patients are encouraged to speak to their licensed aesthetic specialist to determine if treatment is right for them.
“In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. Many of my patients are often surprised by the significant impact that changes in these areas can have,” said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator. “With the approval of BOTOX® Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve.”
In Phase III clinical studies, the primary endpoint was met, demonstrating statistical significance for the improvement in appearance of platysma bands from baseline with BOTOX® Cosmetic versus placebo (p<0.0001).† This measure was based on both investigator and subject assessment. All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments.1 For example, in two clinical studies, a majority of patients (65% and 62%) reported being “Very Satisfied” or “Satisfied” (top two out of five responses) with the appearance of their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of BOTOX® Cosmetic, compared to 12% in both studies with placebo.
Patients interested in learning more about BOTOX® Cosmetic for platysma bands are encouraged to enroll in Allē, the Allergan Aesthetics loyalty rewards program. In serving more than seven million Members across ~30,000 practices to date, part of Allē’s mission is to help educate consumers about aesthetic treatments and to simplify office operations for practices. From its inception, Allē has disrupted the aesthetics industry by offering the most robust rewards program. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 50 non-Allergan Aesthetics treatments and brands. By providing Members with information, tools, and incentives, and now with flexible ways to pay through Allē Payment Plans powered by Cherry‡, Allē empowers consumers along their treatment journey, making the next product purchase or treatment closer within reach.
To learn more about BOTOX® Cosmetic, visit www.botoxcosmetic.com and follow @botoxcosmetic on social media.
*Nine million based on 2021 U.S. Census Projections: calculated from 2021 total population projections from a survey of 15,295 participants of which 3.8% indicated they were “Very” or “Extremely Bothered” (top two out of five responses) by their platysma bands.6
†Primary endpoint was a multi-component ≥ 2-grade 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 2.1
‡Payment options through Cherry Technologies, Inc. are issued by the following lending partners: www.withcherry.com/lending-partners/. Term length, approval amount, 0% APR and other promotional rates are subject to eligibility. See www.withcherry.com/terms for details. Iowa only: Borrowers are subject to Iowa state specific underwriting criteria. APR for all Iowa borrowers is capped at 20.99%.
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, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com.
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.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity
Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.
Reference:
- BOTOX® Cosmetic Prescribing Information, October 2024.
- Dysport® Prescribing Information, 2020.
- Xeomin® Prescribing Information, 2024.
- Jeuveau® Prescribing Information, 2020.
- Daxxify® Prescribing Information, 2022.
- Allergan Data on File. 2023 Aesthetic Market Sizing. 2023.
SOURCE: AbbVie
Post Views: 5,093
- The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow’s Feet Lines, and Now Platysma Bands in Adults1-5
- With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in Adults1-5
IRVINE, CA, USA I October 18, 2024 I Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.1 BOTOX® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow’s feet lines, and now platysma bands, making it the first product of its kind to go beyond the face.1-5
“Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands.6* Until now, treatment options have been limited and with this approval, there is a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck,” said Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics. “This fourth indication for BOTOX® Cosmetic represents true innovation. We’re excited to open new doors for patients and providers, helping them to achieve their aesthetic goals.”
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. Treatment with BOTOX® Cosmetic works beneath the surface to temporarily reduce the underlying muscle activity and improves the appearance of the bands connecting the neck and jaw.1 By injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of BOTOX® Cosmetic based on severity—26, 31, or 36 units—BOTOX® Cosmetic temporarily reduces underlying muscle activity.1 Patients are encouraged to speak to their licensed aesthetic specialist to determine if treatment is right for them.
“In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. Many of my patients are often surprised by the significant impact that changes in these areas can have,” said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator. “With the approval of BOTOX® Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve.”
In Phase III clinical studies, the primary endpoint was met, demonstrating statistical significance for the improvement in appearance of platysma bands from baseline with BOTOX® Cosmetic versus placebo (p<0.0001).† This measure was based on both investigator and subject assessment. All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments.1 For example, in two clinical studies, a majority of patients (65% and 62%) reported being “Very Satisfied” or “Satisfied” (top two out of five responses) with the appearance of their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of BOTOX® Cosmetic, compared to 12% in both studies with placebo.
Patients interested in learning more about BOTOX® Cosmetic for platysma bands are encouraged to enroll in Allē, the Allergan Aesthetics loyalty rewards program. In serving more than seven million Members across ~30,000 practices to date, part of Allē’s mission is to help educate consumers about aesthetic treatments and to simplify office operations for practices. From its inception, Allē has disrupted the aesthetics industry by offering the most robust rewards program. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 50 non-Allergan Aesthetics treatments and brands. By providing Members with information, tools, and incentives, and now with flexible ways to pay through Allē Payment Plans powered by Cherry‡, Allē empowers consumers along their treatment journey, making the next product purchase or treatment closer within reach.
To learn more about BOTOX® Cosmetic, visit www.botoxcosmetic.com and follow @botoxcosmetic on social media.
*Nine million based on 2021 U.S. Census Projections: calculated from 2021 total population projections from a survey of 15,295 participants of which 3.8% indicated they were “Very” or “Extremely Bothered” (top two out of five responses) by their platysma bands.6
†Primary endpoint was a multi-component ≥ 2-grade 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 2.1
‡Payment options through Cherry Technologies, Inc. are issued by the following lending partners: www.withcherry.com/lending-partners/. Term length, approval amount, 0% APR and other promotional rates are subject to eligibility. See www.withcherry.com/terms for details. Iowa only: Borrowers are subject to Iowa state specific underwriting criteria. APR for all Iowa borrowers is capped at 20.99%.
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, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com.
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.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
– Moderate to severe platysma bands associated with platysma muscle activity
Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.
Reference:
- BOTOX® Cosmetic Prescribing Information, October 2024.
- Dysport® Prescribing Information, 2020.
- Xeomin® Prescribing Information, 2024.
- Jeuveau® Prescribing Information, 2020.
- Daxxify® Prescribing Information, 2022.
- Allergan Data on File. 2023 Aesthetic Market Sizing. 2023.
SOURCE: AbbVie
Post Views: 5,093
