Revance Therapeutics, Inc. (NASDAQ: RVNC) has unveiled significant insights into DAXXIFY® for the treatment of cervical dystonia at the American Academy of Neurology (AAN) annual meeting, running from April 13-18, 2024, in Denver, Colorado.
The presentations, ASPEN-1 and ASPEN-OLS (open label study), revealed compelling findings. A fresh analysis showcased that among patients opting for early retreatment with DAXXIFY®, approximately 50% of peak efficacy persisted at retreatment request. Moreover, in the ASPEN-OLS 52-week long-term follow-up study, about 60% of retreatments occurred at 16 weeks or later. These findings underscore the potential of DAXXIFY® to provide prolonged symptom control, affording physicians flexibility in tailoring treatment intervals for individual patients, beyond the FDA and payer-defined minimum of 12 weeks, observed with conventional neurotoxins. Notably, adverse event rates remained consistently low across all retreatment scenarios.
Dr. David A. Hollander, MD, MBA, Chief Medical Officer and Global Therapeutics Franchise Lead, commented on these findings, highlighting the opportunity for physicians to customize doses and retreatment intervals to meet patients’ needs effectively, thereby mitigating the symptom fluctuations often experienced in cervical dystonia cases.
Another poster, led by Dr. Han Lee and colleagues, delved into the innovative formulation of DAXXIFY® and the role of Revance’s custom-engineered peptide (RTP004) in clinical efficacy. The data showcased the advantages of RTP004, including heightened binding of neurotoxin to cell membranes, facilitating increased toxin penetration into neurons, dose-dependent enhancement of SNAP-25 cleavage in neurons, and targeted localization in the injected muscle. This formulation’s improved bioavailability enables the administration of lower core neurotoxin amounts while sustaining long-term benefits, contributing to DAXXIFY’s robust safety profile and distinctive performance.
Poster Details:
Title: Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical Dystonia: Potential for a New Treatment Paradigm With DaxibotulinumtoxinA Authors and Affiliation: Aaron Ellenbogen, Robert A. Hauser, Atul Patel, Peter McAllister, Domenico Vitarella, Todd Gross, Rashid Kazerooni, Conor J. Gallagher, David A. Hollander; Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA; University of South Florida, Tampa, FL, USA; Kansas City Bone & Joint Clinic, Overland Park, KS, USA; New England Institute for Neurology and Headache, Stamford, CT, USA; Revance Therapeutics, Inc., Nashville, TN, USA
Title: Influence of Novel Formulation in DaxibotulinumtoxinA on Efficacy for Treatment of Cervical Dystonia Authors and Affiliation: Han Lee, André F. Batista, Conor J. Gallagher; The Permanente Medical Group, San Leandro, CA, USA; Revance Therapeutics, Inc., Nashville, TN, USA