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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

In October 2020, Revance announced positive topline results from the pivotal ASPEN-1 Phase 3 clinical trial evaluating the efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia. The results support the potential use of DaxibotulinumtoxinA for Injection as a new treatment option for cervical dystonia, where duration is a significant unmet need.2,3 DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA.

Not an actual patient

40 – 60 Years

Cervical dystonia typically affects people between 40 – 60 years of age.4

2x

Cervical dystonia affects women approximately 2x as often as men.4

60,000

Estimated Americans who suffer from cervical dystonia.4

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 weeks4. The payers typically only allow retreatment every 12 weeks3. Patients’ painful symptoms often reappear before their next BoNT treatment3. Most patients prefer a treatment regimen which can offer long lasting symptom relief between BoNT-A injections.2

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

Not an actual patient

Burden for patients to travel for treatment every 3 months.3

Of patients desire longer lasting benefits between treatments.2

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

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

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 week 4 and 6 compared to placebo. TWSTRS was used to assess each patient’s severity, disability and pain caused by cervical dystonia.

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 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%).

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

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

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