Breakthrough approval offers new treatment for chronic neck disorder.
The FDA has given the green light to Daxxify for the treatment of cervical dystonia in adults, marking its first therapeutic indication. This approval is grounded in robust clinical data, offering a new option for patients suffering from this chronic movement disorder.
- Approval based on ASPEN-1 and ASPEN-OLS studies, showing safety and effectiveness.
- In ASPEN-1, 382 participants received Daxxify or placebo; high dose group showed a change of 12.7 points, low dose group 10.9 points in TWSTRS at weeks 4 and 6.
- Median duration of effect was 20.3 weeks for high dose, 24.0 weeks for low dose.
- Common adverse events included dysphagia, muscular weakness, and injection site pain.
- Black box warning about distant spread of toxin effect included in prescribing information.
- ASPEN-OLS involved 357 participants receiving up to 4 sequential doses for up to 88 weeks, with improvements in TWSTRS.
- Cervical dystonia is characterized by repetitive rotation and/or bending of the neck; Daxxify is the first peptide-formulated neuromodulator for the condition.
- Daxxify’s approval provides a new, effective treatment option for cervical dystonia, with demonstrated efficacy and safety.