Daxxify (daxibotulinumtoxinA-lanm) / Fosun Pharma, Crown Labs - LARVOL DELTA

Successful Treatment of Sialorrhea with Daxibotulinum Toxin A (AAN 2025) - "Currently, IncobotulinumtoxinA (USA and Europe) and RimabotulinumtoxinB (USA) are approved for this indication. All surveys suggest DaxibotulinumtoxinA provided sustained improvement of sialorrhea and may provide a novel alternative option for those refractory to other treatments."

CNS Disorders • Movement Disorders • Parkinson's Disease

Insights from Clinical Experience with DaxibotulinumtoxinA for the Treatment of Cervical Dystonia (AAN 2025) - "Our cohort consisted of both toxin-naïve and toxin-experienced individuals allowing for a broad evaluation of dosing strategies and treatment outcomes.Patients received doses ranging between 60-570U, with toxin-experienced individuals transitioning from OnabotulinumtoxinA or IncobotulinumtoxinA using a conversion ratio ranging from 1:1 to 1:3. Daxxify is a good treatment option in patients with CD, particularly in patients unsatisfied with the outcomes of previous therapies. Further studies may be warranted to explore its broader applications in the treatment of other conditions and to optimize dosing strategies for individualized patient care."

Clinical • CNS Disorders • Dystonia • Gastrointestinal Disorder • Infectious Disease • Migraine • Movement Disorders • Pain • Parkinson's Disease

DaxibotulinumtoxinA Treatment for Laryngeal Respiratory Dystonia. (PubMed, J Voice) - "DAXI appears to provide ~80% better duration than the patient's average BtxA injection and a 57% improvement than his best BtxA injection. DAXI is a safe and realistic alternative to BtxA injection in patients with LRD."

Journal • CNS Disorders • Dystonia • Movement Disorders • Pulmonary Disease

Successful Treatment of Severe, Poorly Controlled Benign Essential Blepharospasm with DaxibotulinumtoxinA. (PubMed, Ophthalmic Plast Reconstr Surg) - "This case highlights a 57-year-old male with severe, poorly controlled benign essential blepharospasm despite high-dose injections of onabotulinumtoxinA and incobotulinumtoxinA...Notably, the patient experienced 50% to 75% efficacy retention at 3 months postinjection, significantly better than his response to other botulinum toxin type A products. This case suggests that daxibotulinumtoxinA may be an effective treatment for benign essential blepharospasm including patients experiencing poor symptom control with other botulinum toxin type A products."

Journal • CNS Disorders • Dystonia • Movement Disorders

Dysphagia and Muscle Weakness Secondary to Botulinum Toxin Type A Treatment of Cervical Dystonia: A Drug Class Analysis of Prescribing Information. (PubMed, Toxins (Basel)) - "Current clinical trials suggest that DAXI, a novel BoNTA formulation, provides a potentially wider safety margin compared with other approved BoNTAs for CD. The lower amount of core neurotoxin administered at approved doses compared with conventional BoNTAs may explain low on-target ADRs like muscle weakness, whereas reduced diffusion from the injection site is thought to be responsible for low off-target ADRs like dysphagia."

Journal • CNS Disorders • Dystonia • Gastrointestinal Disorder • Movement Disorders

Do Lower Doses of Botulinum Neurotoxin Type-A Offer a Longer Duration of Effect and Superior Efficacy in Patients with Cervical Dystonia? (MDS Congress 2024) - "Background: Recently, a long-acting neurotoxin, daxibotulinumtoxinA, was approved for cervical dystonia (CD)...Patients with a history of essential tremor, who previously received rimabotulinumtoxinB, or received injections for multiple indications, were excluded from the study. The cutoff between low-dose and high-dose groups was 220 units for those who received either onabotulinumtoxinA or incobotulinumtoxinA and 500 units for those who received abobotulinumtoxinA... Our preliminary data showed that patients administered a lower dose of BoNT-A reported a longer duration of effect and superior efficacy compared to those who received a higher dose. While a potential explanation for our result is a greater disease burden in patients requiring higher doses, it is also possible that there is a ceiling effect, and we are unnecessarily overdosing patients."

Clinical • CNS Disorders • Dystonia • Essential Tremor

DaxibotulinumtoxinA for injection to treat moderate or severe glabellar lines: A randomized, multicenter, Phase III, double-blind, placebo-controlled trial in China. (PubMed, J Plast Reconstr Aesthet Surg) - "DAXI provided durable efficacy and acceptable safety for treating moderate/severe glabellar lines in Chinese participants."

Journal • P3 data

A randomized, double-blind, placebo-controlled trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. (PubMed, PM R) - "Results from this Phase 2 study indicate that DAXI 500 U is effective and well tolerated for treatment of adults with ULS."

Clinical • Journal • Cardiovascular • CNS Disorders • Movement Disorders • Vascular Neurology

Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical Dystonia: Potential for a New Treatment Paradigm with DaxibotulinumtoxinA (MDS Congress 2024) - "These findings demonstrate, for the first time, a significant proportion of efficacy remained in patients who requested BoNT reinjection for their CD symptoms. With the long duration of benefit of daxibotulinumtoxinA, there is opportunity for a new approach whereby physicians can tailor treatments to individual patient needs and treat patients as their symptoms re-emerge at 12 weeks or beyond. This abstract has been accepted for presentation at AAN 2024 this April 13-18, 2024."

Clinical • CNS Disorders • Dystonia

Efficacy and Safety of DaxibotulinumtoxinA-lanm for Injection in Adults with Cervical Dystonia: Pooled Global Analysis of ASPEN-1 and ASPEN-1-CN (MDS Congress 2024) - "This pooled analysis of Phase 3 trials from the USA/EU (ASPEN-1) and China (ASPEN-1-CN) demonstrates that DAXI is an effective, safe, and long-acting treatment for CD. Key adverse events occurred at rates lower than prior pivotal trials of BoNT products for this indication."

Clinical • CNS Disorders • Dystonia

DAXXIFY® for Cervical Dystonia: From Clinical Trials to Real World Experience (MDS Congress 2024) - "Sponsored by Revance Therapeutics"

Clinical • Real-world • Real-world evidence • CNS Disorders • Dystonia

DAXXIFYTM (DaxibotulinumtoxinA-Lanm) for Injection, for Intramuscular Use. (PubMed, Skinmed) - "Treatment success proportions were 73.2%, 77.7%, and 79.6% across the three consecutive treatment cycles. The recommended dose is 40 units for the Glabellar-complex divided in traditional five intramuscular injections at five injection sites (medial and lateral corrugator bilaterally and one injection in the procerus muscle)."

Clinical • Journal

Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement? (PubMed, Dermatol Surg) - "Advances in BoNTA technology can provide patients with greater options for treatment outcomes. The potential for enhanced localized effects with DAXI may contribute to more precise and targeted effects on muscle activity and additional aesthetic benefits to patients."

Journal • Review

Open Label, 6-month Study for High Frequency and Chronic Migraine, (clinicaltrials.gov) - P=N/A | N=20 | Active, not recruiting | Sponsor: Ki Health Partners. LLC | Recruiting ➔ Active, not recruiting | N=10 ➔ 20

Enrollment change • Enrollment closed • CNS Disorders • Migraine • Pain

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: University of California, San Francisco | Recruiting ➔ Active, not recruiting

Enrollment closed • Dysphonia • Otorhinolaryngology

DaxibotulinumtoxinA (Daxxify) for frown lines. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Achieving Durable Forehead Line Outcomes With DaxibotulinumtoxinA: Early Experience in Real-World Clinical Practice. (PubMed, Aesthet Surg J Open Forum) - "With previous generations of BoNT-A products, some degree of migration from the upper frontalis injection sites and/or the glabella injection sites into the mid and low frontalis is sufficient to prevent this effect, but the precision of DAXI demands that these fibers be more deliberately addressed with a larger number of individual injections. Through the use of more injection points, a wider area of treatment, and customization to fit patient needs, duration similar to that observed in clinical studies (20.9 weeks) can be achieved using between 20% and 33% fewer units of DAXI."

Journal • Real-world • Real-world evidence

Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Revance Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Revance Therapeutics, Inc.

New P2 trial

An Open Label, Study of DaxibotulinumtoxinA for Migraine Prevention (clinicaltrials.gov) - P=N/A | N=10 | Active, not recruiting | Sponsor: Ki Health Partners. LLC | Recruiting ➔ Active, not recruiting | N=20 ➔ 10

Enrollment change • Enrollment closed • CNS Disorders • Migraine • Pain

Influence of Novel Formulation in DaxibotulinumtoxinA on Efficacy for Treatment of Cervical Dystonia (AAN 2024) - "In clinical trials for CD DAXI at a dose of 250U, which contains approximately half the amount of core neurotoxin as the 236U approved dose for onabotulinumtoxinA for CD, showed a median time to loss of efficacy of 20 weeks.Design/The effect of RTP004 and HSA on BoNT/A binding to neuronal cells was assessed via cell-binding assays in N2a cells (mouse) and SiMa cells (human). We have demonstrated that the interaction of RTP004 with the 150-kDa BoNT/A can enhance binding to neurons and cleavage of the intracellular substrate, SNAP-25. This data illustrates the importance of formulation on the clinical performance of a BoNT product and the impact of the novel peptide excipient in DAXI."

Clinical • CNS Disorders • Dystonia • Movement Disorders

Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical dystonia: Potential for a New Treatment Paradigm with DaxibotulinumtoxinA (AAN 2024) - "These findings demonstrate, for the first time, a significant proportion of efficacy remained in patients who requested BoNT reinjection for their CD symptoms. With the long duration of benefit of daxibotulinumtoxinA, there is opportunity for a new approach whereby physicians can tailor treatments to individual patient needs and treat patients as their symptoms re-emerge at 12 weeks or beyond."

Clinical • CNS Disorders • Dystonia • Movement Disorders

Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Montefiore Medical Center | Trial primary completion date: Jul 2025 ➔ Apr 2026

Trial primary completion date • CNS Disorders

Complexing Protein-Free Botulinum Neurotoxin A Formulations: Implications of Excipients for Immunogenicity. (PubMed, Toxins (Basel)) - "Reportedly, the rate of antibody-mediated secondary non-response is lowest in complexing protein-free (CF) IncobotulinumtoxinA (INCO). Here, the published data and literature on the composition and properties of the three commercially available CF-BoNT/A formulations, namely, INCO, Coretox® (CORE), and DaxibotulinumtoxinA (DAXI), are reviewed to elucidate the implications for their potential immunogenicity...Presently, no data are available on the immunogenicity of CORE in human beings. It remains to be seen whether all three CF BoNT/A formulations demonstrate the same low immunogenicity in patients over a long period of time."

Journal • Review

Applications for Neurotoxins in the Face and Neck. (PubMed, Atlas Oral Maxillofac Surg Clin North Am) - No abstract available

Journal • Review • Aesthetic Medicine