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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.
Revance is also considering studying DAXXIFY® for Injection for migraines. Potential timing of clinical studies is currently being evaluated.
PIPELINE
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
THERAPEUTICS
DAXXIFY®
Cervical dystonia
FDA Approved in Q3 2023
Upper limb spasticity
Phase 2 study completed in 2021
INDICATION
DaxibotulinumtoxinA for 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.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DaxibotulinumtoxinA for Injection 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. DaxibotulinumtoxinA for Injection is not approved for the treatment of spasticity or any conditions other than glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DaxibotulinumtoxinA for Injection 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 DaxibotulinumtoxinA for Injection 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 (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Drug Interactions
Co-administration of DaxibotulinumtoxinA for Injection 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 DaxibotulinumtoxinA for Injection may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DaxibotulinumtoxinA for Injection is unknown.
Use in Specific Populations
DaxibotulinumtoxinA for Injection is not recommended for use in children or pregnant women.
Please see DaxibotulinumtoxinA for Injection full Prescribing Information, including Boxed Warning and Medication Guide.
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:
Glabeller lines (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), 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
