Proven results

The Largest Phase 3 Clinical Trial Program

conducted for a neuromodulator to treat glabellar lines.13

  • 65 Trial Sites13,14

  • 2,823 Patients14

  • 4,444 Treatments14

Fast Onset

Onset as early as day 1 and typically within 2 days.1*

*Based on pooled patient diary data from SAKURA 1 and SAKURA 2.2,8

Long-Lasting Results

Sustained glabellar line improvement with the convenience of as few as 2 treatments per year for busy patients.10*

DAXXIFY® gradually softens over a prolonged period.2†

*At least 50% of patients in SAKURA 1 and SAKURA 2 had none or mild frown lines for 24 weeks (6 months) and 23.9 weeks (6 months) or longer, respectively, per both investigator’s and patient’s assessments.10
Median time to return to baseline wrinkle severity was 27.7 weeks in SAKURA 1 and 26 weeks in SAKURA 2.10

SAKURA 18a

SAKURA 28b

aPivotal, placebo-controlled, single-treatment trial conducted at 15 sites over 36 weeks; N=303 (DAXXIFY®: 201; placebo: 102).8
bPivotal, placebo-controlled, single-treatment trial conducted at 15 sites over 36 weeks; N=306 (DAXXIFY®: 205; placebo: 101).8
cProportion of patients from SAKURA 1 and SAKURA 2 rated as 0 or 1 (none or mild) by the investigator.8
dProportion of patients from SAKURA 1 and SAKURA 2 rated as 0 or 1 by the patient.8

74% achieved a ≥2−grade improvement at week 4 per both investigator’s and patient’s assessments.2,8§

§Per pooled data from SAKURA 1 and SAKURA 2.2,8

The Look

Give patients a better look vs baseline.3

Smooths even the deepest lines.2,15,16

64% of patients achieved an improvement in the appearance of skin texture at week 2.3||

||From a post hoc analysis of a Phase 2 clinical study with 60 patients.3

See results

Safety

Per clinical trials, DAXXIFY® is generally safe and well tolerated, with no serious treatment-related adverse events reported.2,8

ADVERSE REACTIONS ≥1% AND MORE FREQUENT THAN PLACEBO IN SAKURA 1 AND SAKURA 2 (POOLED)8
DAXXIFY®
n=406
n (%)
PLACEBO
n=203
n (%)
HEADACHE 9 (2%) 0 (0%)
EYELID PTOSIS 26 (6%) 4 (2%)
FACIAL PARESISa
5 (1%) 0 (0%)

aFacial paresis, including facial asymmetry, is a broad term in the adverse event coding system, and in SAKURA 1 and SAKURA 2 this included 1 patient with unilateral over-arched brow and 4 patients with frontalis muscle weakness.8,17

The incidence of these adverse reactions did not increase with multiple retreatments.8

The most common side effects seen in clinical trials occurred within one to two weeks after injection and lasted only a short while. This is consistent with other neuromodulator treatments.18

In the repeat-dose, open-label SAKURA 3 safety study, 2,691 patients were treated with 40U of DAXXIFY®. The adverse reaction profile was similar to that reported in single-dose trials.8,14 Injection site reactions were the most common adverse reactions, reported in 9% of patients [including injection site pain (4%), injection site erythema (3%), injection site edema (3%), injection site bruising (1%), injection site papule (<1%), and injection site pruritus (<1%)], followed by headache (5%), edema (2%), erythema (2%), and eyelid ptosis in 1% of patients.8

Publications

  • Journal of the American Academy of Dermatology

    DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)

    Download Article (PDF)
  • Plastic and Reconstructive Surgery

    DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: Results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)

    Download Article (PDF)
  • Toxins journal

    Clinical immunogenicity of DaxibotulinumtoxinA for Injection in glabellar lines: Pooled data from the SAKURA phase 3 trials

    Download Article (PDF)

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WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than glabellar lines.

INDICATION DAXXIFY® (daxibotulinumtoxinA-Ianm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

IMPORTANT SAFETY INFORMATION

Contraindications
DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).

Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

The potency Units of DAXXIFY® are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.

Adverse Reactions
The most commonly observed adverse reactions (≥1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).

Drug Interactions
Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.

Use in Specific Populations
DAXXIFY® is not recommended for use in children or pregnant women.

Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.

DAXI-001720.2

REFERENCES

  1. 1. Data on File. D220801001. Newark, CA: Revance Therapeutics, Inc, 2022.
  2. 2. Bertucci V, Solish N, Kaufman-Janette J, et al. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020;82(4):838-845. doi:10.1016/j.jaad.2019.06.1313.
  3. 3. Data on File. D231201010. Newark, CA: Revance Therapeutics, Inc, 2023.
  4. 4. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2023.
  5. 5. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021.
  6. 6. DYSPORT®. Prescribing Information. Ipsen Biopharmaceuticals, Inc.; 2023.
  7. 7. JEUVEAU®. Prescribing Information. Evolus, Inc; 2020.
  8. 8. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022.
  9. 9. Data on File. The Harris Poll Facial Injectables Landmark Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018.
  10. 10. Carruthers JD, Fagien S, Joseph JH, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: results from each of two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020;145(1):45-58.
  11. 11. Pulkoski-Gross MJ, Fang C, Shai R, Too P. A cell-penetrating peptide binds directly to and enhances membrane binding of the core toxin of botulinum toxin type A (BoNTA). Poster presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA.
  12. 12. Solish N, Carruthers J, Kaufman J, Rubio R, Gross T, Gallagher C. Overview of DaxibotulinumtoxinA for Injection: a novel formulation of botulinum toxin type A. Drugs. 2021;81:2091-2101.
  13. 13. Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label, phase 3 safety study. Dermatol Surg. 2020;47(1):48-54. doi:10.1097/DSS.0000000000002531t.
  14. 14. Green JB, Mariwalla K, Coleman K, et al. A large, open-label, phase 3 safety study of daxibotulinumtoxinA for injection in glabellar lines: a focus on safety from the SAKURA 3 study. Dermatol Surg. 2021;47(1):42-46. doi:10.1097/DSS.0000000000002463.
  15. 15. Brown J, Stephenson J, Kooken K, Sparrow J. Impact of DaxibotulinumtoxinA for Injection on skin smoothness following treatment of glabellar lines. Poster presented at: Derm2023 NP/PA CME Conference; August 3-6, 2023; Las Vegas, NV.
  16. 16. Data on File. Gross. American Academy of Dermatology. Newark, CA: Revance Therapeutics, Inc, 2021.
  17. 17. Data on File. Sak_1_and_Sak_2_facial paresis-asymmetry. Newark, CA: Revance Therapeutics, Inc, 2018.
  18. 18. Data on File. D220801002. Newark, CA: Revance Therapeutics, Inc, 2021.

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