Upper Limb Spasticity

THERAPEUTICS PIPELINE

Upper Limb Spasticity

Upper limb spasticity is a neurological condition that affects movement in the arms and/or hands and occurs most commonly after a stroke or traumatic brain injury. The condition is associated with muscle stiffness, spasms, and inability to perform daily tasks.1

In November 2020, Revance announced results from a Phase 2 clinical trial evaluating DAXXIFY® for Injection for the management of plantar fasciitis. Revance plans to analyze the data further for additional insights, however our primary focus will be on neurological indications, where the market and path to approval are well established.

Revance

Plantar Fasciitis in Numbers

0
M
Cases Worldwide

An estimated 12 million people worldwide suffer from spasticity.2

>
0
%
Receiving Treatment

An estimated 20% of the patient populations currently receives treatment.3

0
K
Cases in the U.S.

An estimated 100,000 people in the U.S. suffer from upper limb spasticity.2

Botulinum toxin treatment is the standard of care for the treatment of management of focal upper limb spasticity. Other treatment options include muscle relaxants, physical therapy, splints, casts and braces, electrical stimulation, and surgery. Long-acting symptom relief is needed to address current challenges and is an unmet need of upper limb spasticity treatment.

Botulinum toxin treatment is the standard of care for the treatment of management of focal upper limb spasticity. Other treatment options include muscle relaxants, physical therapy, splints, casts and braces, electrical stimulation, and surgery. Long-acting symptom relief is needed to address current challenges and is an unmet need of upper limb spasticity treatment.

* Not an actual patient

UNMET NEED

0
mos

Improvement of spasticity symptoms with currently approved botulinum toxin treatment may last an average of three months.⁵

0
%

Survey of patients with spasticity overwhelmingly (72%) indicated the desire for a longer lasting treatment⁶

Aesthetics Pipeline
Aesthetics Clinical Highlights
Therapeutics Pipeline
Therapeutics Clinical Highlights

References

  • 1 –SPASTICITY. AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS. RETRIEVED FROM: HTTPS://WWW.AANS.ORG/EN/PATIENTS/NEUROSURGICAL-CONDITIONS-AND-TREATMENTS/SPASTICITY. ACCESSED 9/29/2020
  • 2 –WHAT IS SPASTICITY? LIFE WITH SPASTICITY. RETRIEVED FROM: HTTPS://LIFEWITHSPASTICITY.COM/DEFINITION-AND-PREVALENCE#DEFINITION. ACCESSED 10/09/2020
  • 3 –MUNIN M ET AL. METHODOLOGY OF A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING, 36-WEEK, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF DAXIBOTULINUMTOXINA FOR INJECTION FOR THE TREATMENT OF UPPER LIMB SPASTICITY IN ADULTS AFTER STROKE OR TRAUMATIC BRAIN INJURY (JUNIPER). POSTER PRESENTED AT 2019 TOXINS. 16-19 JANUARY, 2019. COPENHAGEN, DENMARK.
  • 4 –SPASTICITY. AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS. RETRIEVED FROM: HTTPS://WWW.AANS.ORG/EN/PATIENTS/NEUROSURGICAL-CONDITIONS-AND-TREATMENTS/SPASTICITY. ASSESSED: 11/16/2020
  • 5 –SIMPSON DM, ET AL. PRACTICE GUIDELINE UPDATE SUMMARY: BOTULINUM NEUROTOXIN FOR THE TREATMENT OF BLEPHAROSPASM, CERVICAL DYSTONIA, ADULT SPASTICITY, AND HEADACHE. REPORT OF THE GUIDELINE DEVELOPMENT SUBCOMMITTEE OF THE AMERICAN ACADEMY OF NEUROLOGY. NEUROLOGY. 2016; MAY 10;86(19): 1818–1826.
  • 6 –JACINTO J, VARRIALE P, PAIN E, LYSANDROPOULOS A, ESQUENAZI A. PATIENT PERSPECTIVES ON THE THERAPEUTIC PROFILE OF BOTULINUM NEUROTOXIN TYPE A IN SPASTICITY. FRONTIERS IN NEUROLOGY, 2020; VOLUME 11, ARTICLE 388.

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

DAXI-004726

Facebook Instagram Twitter LinkedIn

FOR CUSTOMER SERVICE, PRODUCT INFORMATION, NEW ACCOUNTS OR ADVERSE EVENTS CALL: 877-3REV-NOW

1222 DEMONBREUN ST

20TH FLOOR

NASHVILLE, TN 37203

©2025 REVANCE.
RHA® and RHA Redensity® are registered trademarks of TEOXANE SA, manufactured in Switzerland. The TEOXANE RHA® Collection is exclusively distributed by Revance®. All other trademarks are the property of their respective owners.
CORP-00147

SOCIAL MEDIA COMMUNITY GUIDELINES PRIVACY POLICY TERMS OF USE
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.