Clinical Highlights

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Clinical Highlights

Fabi, Sabrina G. MD et al

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

AUGUST 2021

DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study

Green, Jeremy B. MD et al

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines

AUGUST 2021

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines

Faivre, Jimmy et al

Advanced Concepts in Rheology for the Evaluation of Hyaluronic Acid–Based Soft Tissue Fillers

JANUARY 2021

Advanced Concepts in Rheology for the Evaluation of Hyaluronic Acid–Based Soft Tissue Fillers

Cohen, Joel L. et al.

Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program

February 2021

Dermatologic Surgery – Glogau, Richard MD*; Kontis, Theda C. MD†

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection

August 2021

Gary Monheit, M.D.

Efficacy and Safety of Two Resilient Hyaluronic Acid Fillers in the Treatment of Moderate-to-Severe Nasolabial Folds

August 2021

Joseph Jankovic M.D. et al

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study

March 2018

Dr. Joseph Jankovic

Learn More About Cervical Dystonia with Dr. Joseph Jankovic

Learn More About Cervical Dystonia with Dr. Joseph Jankovic

Revance Therapeutics

Revance Announces Top-Line Results for ASPEN-1

Revance Announces Top-Line Results for ASPEN-1

Dermatologic Surgery – Hema Sundaram, MD, FAAD, Ava Shamban, et al.

Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study

December 2021

Glogau, Richard MD*; Kontis, Theda C. MD†

Progressive Improvement in Static Glabellar Lines After Repeated Treatment With DaxibotulinumtoxinA for Injection

August 2021

Journal of the American Academy of Dermatology – Vince Bertucci, M.D.

DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)

December 2019

Dermatologic Surgery – Berthold Rzany, M.D. et al

Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles

October 2019

Plastic and Reconstructive Surgery – Jean Carruthers M.D. et al

DaxibotulinumtoxinA in the treatment of glabellar lines. Results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)

October 2019

Journal of Cosmetic Dermatology – Joely Kaufman-Janette MD et al.

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate‐to‐severe nasolabial folds: A 64‐week, prospective, multicenter, controlled, randomized, double‐blind and within‐subject study

August 2019

Movement Disorders – Joseph Jankovic M.D. et al

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study

March 2018

Dermatologic Surgery – Vince Bertucci M.D. et al

Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines. Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines

December 2017

Dermatologic Surgery – Jean Carruthers M.D. et al

Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines. A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo

November 2017

Dermatologic Surgery – Enrique Garcia-Murray M.D. et al

Safety and Efficacy of RT002, an Injectable Botulinum Toxin Type A, for Treating Glabellar Lines

January 2015

Disclaimer

*DAXXIFY® (daxibotulinumtoxinA-Ianm) injection was approved by the FDA in 09/22 for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults and for the treatment of cervical dystonia in adults in 08/23. DAXXIFY® is currently being evaluated in additional therapeutic and aesthetic indications and was formerly known as RT002.

IMPORTANT SAFETY INFORMATION for DAXXIFY® (daxibotulinumtoxinA-Ianm) for injection

Indications

(daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.

WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.

IMPORTANT SAFETY INFORMATION

Contraindications

DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions

Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency Units of DAXXIFY® are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

Adverse Reactions

The most commonly observed adverse reactions are:

Glabellar lines (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).

Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (6%), muscular weakness (5%), and upper respiratory tract infection (5%).

Drug Interactions

Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.

Use in Specific Populations

DAXXIFY® is not recommended for use in children or pregnant women.

Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.

To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

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WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.