THERAPEUTICS PIPELINE

Cervical Dystonia

Cervical dystonia is a painful and disabling chronic condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck.1

DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection was FDA approved in September 2022 for the temporary improvement of moderate to severe frown lines (glabellar lines).

The ASPEN Phase 3 clinical development program, which includes the ASPEN-1 and ASPEN-OLS studies, evaluated the efficacy and safety of DAXXIFY™ for the treatment of cervical dystonia and were completed in 2020 and 2021, respectively. The results support the potential use of DAXXIFY™ as a new treatment option for cervical dystonia, where duration is a significant unmet need. 2,3

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Cervical Dystonia in Numbers

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-
0
40-60 years of age
Cervical dystonia typically affects people between 40 – 60 years of age4
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times
Women to Men

Women are twice as likely to be affected by cervical dystonia

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K
Americans

An estimated 60,000 Americans suffer from cervical dystonia

Learn More About Cervical Dystonia with Dr. Joseph Jankovic video

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Botulinum toxin (BoNT) injections are current first-line, standard of care for the treatment of cervical dystonia. Conventional BoNTs start to wear off in 8-10 weeks.4 The payers typically only allow retreatment every 12 weeks.3 Patients’ painful symptoms often reappear before their next BoNT treatment.3 Most patients prefer a treatment regimen which can offer long lasting symptom relief between BoNT-A injections.2

* Not an actual patient

Cervical dystonia is a painful, often debilitating condition. A BoNT with longer duration of effect will result in less frequent reinjection and should thus be associated with decreased annualized drug cost, decreased health care utilization and overall treatment cost, as well as improved patient satisfaction.5

Unmet need

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months
Travel for treatment every 3 months creates a burden for patients.3
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%

71% of patients desire longer lasting benefits between treatments2

Revance Announces Top-Line Results for ASPEN-1

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Aspen-2

The recent sBLA submission is supported by data from the ASPEN Phase 3 program, which includes the ASPEN-1 and ASPEN-OLS studies.

ASPEN-1 is a Phase 3, randomized, double-blind, placebo-controlled, parallel group clinical trial evaluating the efficacy and safety of DAXXIFY™ for Injection for the treatment of cervical dystonia in adults.

ASPEN-1 study results suggest that DAXXIFY™ for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually.2,6

The study met the primary endpoint demonstrating a statistically significant improvement in the averaged change in total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score at weeks 4 and 6 compared to placebo. TWSTRS was used to assess each patient’s severity, disability and pain caused by cervical dystonia.

ASPEN-OLS is a Phase 3, open-label, long-term safety trial during which subjects were eligible to receive up to 4 treatments over a 52-week period. ASPEN-OLS met the primary and secondary endpoints finding that DAXXIFY™ was well tolerated and demonstrated safety and efficacy and further confirming the safety findings reported from the Phase 3 ASPEN-1 study.

Primary Endpoint

Met the primary endpoint demonstrating a statistically significant improvement in the averaged change in TWSTRS-total score at weeks 4 and 6 compared to placebo.

Median Duration

Median Duration of Effect up to 24 weeks with 125U dose of DaxibotulinumtoxinA for Injection.

No unexpected adverse events were observed. The three most common treatment-related adverse events (for 125 Units and 250 Units) were injection site pain (7.9%, 4.7%), headache (4.7%, 4.7%), and injection site erythema (4.7%, 2.3%).

Adverse Events

Other Common Adverse Events (for 125 Units and 250 Units) were Dysphagia (1.6%, 3.9%) and muscular weakness (4.7%, 2.3%).

DaxibotulinumtoxinA for Injection was approved by the FDA in [MM/YY] for the [insert based on label] and is currently being evaluated in additional therapeutic and aesthetic indications.

References
1 – Dystonia Medical Research Foundation. Retrieved from: https://dystonia-foundation.org/what-is-dystonia/types-dystonia/cervical-dystonia/. Accessed 8/11/20
2 – Comella, C., Ferreira, J.J., Pain, E. et al. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. J Neurol (2020). https://doi.org/10.1007/s00415-020-10217-7
3 – Revance Market Research 2019: Understanding the Value of DaxibotulinumtoxinA for Injection’s Therapeutic Franchise
4 – NORD (National Organization for Rare Disorders). Cervical Dystonia (July 19, 2019) Retrieved from: https://rarediseases.org/rare-diseases/cervical-dystonia/. Accessed 9/29/20
5 – Marsh W, et al. Systematic review and meta-analysis of the duration of clinical effect of onabotulinumtoxinA in cervical dystonia. BMC Neurology 2014
6 – Data on File. ASPEN CSR. Newark, CA: Revance Therapeutics, Inc, 2022.

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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 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 DAXXIFYfull Prescribing Information, including Boxed Warning and Medication Guide.