FDA approves first therapeutic indication for Daxxify for injection for the treatment of cervical dystonia.- Revance Therapeutics.

Daxxify, powered by Peptide Exchange Technology , was previously approved by the FDA for the temporary improvement of glabellar lines (frown lines) in adults in September 2022 and is the first true innovation in neuromodulator product formulation in more than 30 years.

Cervical dystonia is a chronic, debilitating disease in which the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck. Neuromodulators are considered the first line of treatment for this condition, which effects roughly 60,000 Americans. In 2017, the FDA granted orphan drug designation to Daxxify for the treatment of cervical dystonia in adults.

The U.S. approval of Daxxify for the treatment of cervical dystonia in adults was based on data generated in the Phase III clinical program (ASPEN 1, ASPEN OLS), which included 382 patients and 1,240 treatments across up to five injection cycles over an 88-week time span, based on the masked, randomized ASPEN-1 and ASPEN Open Label Study (OLS). In the pivotal ASPEN clinical study, Daxxify was shown to be effective, generally safe, and well tolerated across both dose groups, 125U and 250U, with a median duration of effect of 24.0 and 20.3 weeks for the two dose groups respectively. Based on the ASPEN OLS study, symptoms continued to improve with successive Daxxify treatments at doses up to 300U, while adverse events remained low. In particular, dysphagia rates (difficulty swallowing) remained low (2.7% for ASPEN-1 and 4.2% for ASPEN-OLS), further supporting Daxxify’s safety profile.

Peter McAllister, M.D., ASPEN investigator and co-founder and medical director of the New England Institute for Neurology and Headache, commented: “As an ASPEN investigator, I am excited to see the approval of a new treatment option to address symptom reemergence prior to retreatment, a common issue for cervical dystonia patients. Currently, patients experience painful and life-limiting symptom recurrence as early as eight to 10 weeks in clinical practice but cannot be re-treated until 12 weeks. Daxxify is the first long-acting neuromodulator that has the potential to address this significant unmet need -- demonstrating durable symptom relief between treatment cycles and providing the opportunity to extend treatment intervals.”