Introducing DaxibotulinumtoxinA-Ianm as a Treatment Option for Cervical Dystonia: Peter J. McAllister, MD, FAAN

WATCH TIME: 5 minutes

"This is the first big change in the whole neurotoxin market in 3 decades, ushering in a whole new era in which we will have personalized medicine for patients with cervical dystonia."

Research shows that botulinum toxin injections have treated conditions for over 30 years yet despite this, it has become common for re-emergence of early symptom among patients. In cervical dystonia, a debilitating disease in which the neck muscles contract involuntarily, 2 of every 3 patients report re-emergence of symptoms in at least 3 months following these treatments. In August 2023, the FDA approved daxibotulinumtoxinA-Ianm (Daxxify; Revance Therapeutics), a long-lasting treatment that offers the potential to improve duration of symptom control in cervical dystonia.¹

The approval was based on results from the phase 3 ASPEN trial (NCT03608397) and its open-label study (OLS; NCT03617367), which included 382 patients and 1240 treatments over an 88-week time span. In ASPEN-1 both the 125- and 250-unit dose groups of daxibotulinumtoxinA met the primary end point of clinically meaningful improvement in the signs and symptoms of cervical dystonia, on average, by weeks 4 and 6. In this randomized, placebo-controlled, parallel-group study, the 125- and 250-unit treatment groups showed improvements of 12.7 and 10.9 points, respectively, on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) whereas those on placebo recorded changes of 4.3 (P <.001 and P = .0006, respectively).²

Months after the Centers for Medicare & Medicaid Services assigned a permanent J-code (J0589), Revance announced the commercial launch for daxibotulinumtoxinA, providing clinicians with a new option to prescribe to patients with cervical dystonia.³ Following this news, Peter J. McAllister, MD, FAAN, the medical director and chief medical officer of New England Center for Neurology and Headache, sat down with NeurologyLive^® in an interview to discuss how daxibotulinumtoxinA's mechanism of action differs from other botulinum toxins. He also talked about the implications of longer-lasting effects of daxibotulinumtoxinA on the treatment schedules and quality of life for patients with cervical dystonia. In addition, McAllister spoke about how the commercial introduction of daxibotulinumtoxinA may impact the awareness and diagnosis rates of cervical dystonia.

REFERENCES
1. Revance announces US FDA acceptance of supplemental biologics license application (sBLA) for Daxxify (DaxibotulinumtoxinA-Ianm) for injection for the treatment of cervical dystonia. News release. January 6, 2023. Accessed May 17, 2024. https://investors.revance.com/news-releases/news-release-details/revance-announces-us-fda-acceptance-supplemental-biologics
2. Revance reports positive results from ASPEN-1 phase 3 trial of daxibotulinumtoxinA for injection in cervical dystonia. News release. Revance Therapeutics. October 14, 2020. Accessed May 17, 2024. https://investors.revance.com/news-releases/news-release-details/revance-reports-positive-results-aspen-1-phase-3-trial
3. Revance Expands into the U.S. Therapeutics Market with the Launch of DAXXIFY® for the Treatment of Cervical Dystonia. News Release. Published May 9, 2024. Accessed May 17, 2024. https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Expands-into-the-U.S.-Therapeutics-Market-with-the-Launch-of-DAXXIFY-for-the-Treatment-of-Cervical-Dystonia