Revance Therapeutics, Inc. (RVNC) announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J0589) for DAXXIFY®?, indicated for the treatment of cervical dystonia in adults. The study, authored by Cynthia L. Comella, M.D., evaluated the safety, duration of response, and efficacy of two doses of DAXXIFY for the treatment of cervical Dystonia (CD), and served as the foundation for Food and Drug Administration (FDA) approval of DAXXIFY for The treatment of cervical dystonia In August 2023. The pivotal Phase 3 clinical study (ASPEN 1), included 301 patients randomized to receive 125 U or 250U of DAXXIFY, or to placebo.1-2 DAXXIFY was shown to be effective, generally safe, and well tolerated across both dose groups, 125U and 250U.

1-2 The primary endpoint was met in both groups, with 12.7 and 10.9 point reductions from baseline in Total TWSTRS score averaged over Weeks 4 and 6 (p<0.01 vs placebo).1-2 Median duration of effect, defined as >80% loss of peak effect, was 24.0 and 20.3 weeks for the two dose groups respectively. 1-2 The low incidence rates of dysphagia (1.9% and 3.6%, respectively) and muscle weakness (4.7% and 2.3%, respectively), further support DAXXIFY?s safety profile.1-2 The Phase 3 clinical program also included a repeat-treatment, open-label safety study (ASPEN OLS) that allowed for up to 4 additional DAXXIFY treatments, which reinforced the findings of ASPEN-1. The total U.S. therapeutic neuromodulator market opportunity for DAXXIFY is $2.7 billion, which includes the over $350 million cervical dystonia market. DAXXIFY® (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.

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. DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s). The potency units of DAXXIFY® are not interchangeable with 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 are: Glabellar lines (=1%): 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%).

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. DAXXIFY® is not recommended for use in children or pregnant women.