We seek to bring innovation to multiple indications, including some of the most debilitating conditions, including cervical dystonia and 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.
Plantar fasciitis is characterized by inflammation and sharp, constant pain in the heel that can become incapacitating. Results from the Phase 2 placebo-controlled clinical trial of DAXXIFY® for Injection for the management of plantar fasciitis were announced in November 2020. 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 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
sBLA accepted in Q1 2023
Plantar fasciitis
Phase 2 study complete early 2021
Upper limb spasticity
Readout in Early 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 is currently being evaluated in additional therapeutic and aesthetic indications. DAXXIFY® was formerly known as RT002.
REFERENCES
1 – Data on File. ASPEN CSR. Newark, CA: Revance Therapeutics, Inc, 2022
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 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 (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
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.
DAXXIFY® is currently under regulatory review for the treatment of cervical dystonia, a debilitating neurological disorder affecting the neck muscles. The sBLA under review includes results from the Phase 3 ASPEN clinical development program, including ASPEN-1 and ASPEN OLS. Results from the pivotal Phase 3 trial suggest that DAXXIFY® has the potential to provide a long duration of efficacy, possibly reducing the risk of symptom re-emergence between treatments.1