Setting the New Standard in Therapeutics
Setting the New Standard in Therapeutics
We seek to bring innovation to multiple indications, including some of the most debilitating conditions, including cervical dystonia and upper limb spasticity.
Positive topline results from Revance’s pivotal ASPEN-1 Phase 3 clinical trial evaluating DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a debilitating neurological disorder affecting the neck muscles, were announced in October 2020. The results demonstrate a potential advancement in the treatment paradigm for patients affected by cervical dystonia. In November 2021, Revance announced positive results from the Phase 3 ASPEN-OLS trial for the treatment of adults with cervical dystonia, an open-label, long-term safety trial during which subjects were eligible to receive up to 4 treatments over a 52-week period.
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 DaxibotulinumtoxinA 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 DaxibotulinumtoxinA for Injection for migraines. Potential timing of clinical studies is currently being evaluated.
Positive Phase 3 open label safety results reported in Q3 2021
Phase 2 study complete
Upper limb spasticity
Readout in Early 2021
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
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.
The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
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.