Portfolio

Therapeutics Pipeline

Portfolio

Therapeutics Pipeline

Clinical Trials
Cervical Dystonia
Cervical Dystonia

DAXXIFY® is now FDA approved for the treatment of cervical dystonia in adults. Cervical dystonia is a painful and often debilitating neurological disorder affecting the neck muscles. 1, 2 FDA approval of DAXXIFY® is based on results from the ASPEN Clinical Program, which demonstrated the safety, efficacy, and long-lasting duration of treatment effect of DAXXIFY®. 3, 4

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Adult Upper Limb Spasticity
Adult Upper Limb Spasticity

In February 2021, Revance announced positive topline Phase 2 data supporting advancement of DAXXIFY® for injection for the treatment of upper limb spasticity. Adult upper limb spasticity is a neurological condition that affects movement in the arms and/or hands and occurs most commonly after a stroke or brain injury.

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Migraine
Migraine

Revance is also considering studying DAXXIFY® for injection for migraines. Potential timing of clinical studies is currently being evaluated.

PIPELINEPRECLINICALPHASE 1PHASE 2PHASE 3
THERAPEUTICS
DAXXIFY®
Cervical dystonia
FDA Approved in Q3 2023
Upper limb spasticity
Phase 2 study completed in 2021

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.

References

  • 1 –Dystonia Medical Research Foundation. Website. https://dystonia-foundation.org/what-is-dystonia/types-dystonia/cervical-dystonia/ Accessed 3/20/23.
  • 2 –Vu JP, Lee HY, Chen Q, et al. Head tremor and pain in cervical dystonia. J Neurol. 2021;268(5):1945-1950
  • 3 –DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2023.
  • 4 –Data on file. ASPEN CSR. Revance. Newark, CA: Revance Therapeutics, Inc, 2018.

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

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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.