– Two presentations highlighting data on DAXXIFY for the treatment of cervical dystonia, including a new analysis from ASPEN trials assessing patient-desired retreatment intervals and one abstract examining the influence of DAXXIFY's formulation on clinical performance

Revance Therapeutics, Inc. (NASDAQ:RVNC), today announced two poster presentations on DAXXIFY for the treatment of cervical dystonia at the annual meeting of American Academy of Neurology (AAN), taking place April 13-18, 2024, in Denver, Colorado.

In the ASPEN-1 and ASPEN-OLS (open label study), a new analysis found that among patients that requested early retreatment with DAXXIFY, roughly 50% of peak efficacy remained at the time of their request. In the ASPEN-OLS 52-week long-term follow-up study, approximately 60% of retreatments were at 16 weeks or later. These findings suggest that the long-acting symptom control with DAXXIFY allows physicians the flexibility to customize treatment intervals for each patient, without being limited by the FDA and payer-defined minimum treatment interval of 12 weeks (as is the case with conventional neurotoxins). Additionally, the studies show that adverse event rates remained low across all retreatment scenarios.

"While it may not be surprising that many patients prefer to be retreated as their symptoms first re-emerge rather than waiting to return to baseline, we believe that the duration of DAXXIFY offers the potential for physicians to tailor doses and retreatment intervals to the needs of individual patients, in order to provide sustained symptom control and reduce the symptom rollercoaster experienced by a vast number of those suffering with cervical dystonia," said David. A. Hollander, MD, MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.

A second poster, by Dr. Han Lee and colleagues, examines DAXXIFY's novel formulation and the role of Revance's custom-engineered peptide (RTP004), in clinical performance. The data shows that the benefits of RTP004 include increased binding of neurotoxin to cell membranes to allow more toxin to enter the neuron, enhanced SNAP-25 cleavage in neurons in a dose-dependent manner, and localization in the injected muscle. By increasing bioavailability, DAXXIFY's formulation allows for a lower amount of core neurotoxin to be administered while maintaining long lasting benefit, which may contribute to the strong safety and differentiated performance profile.

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