Outstanding Efficacy & Duration

Backed By Sakura

The Largest Phase 3 Clinical Trial Program

conducted for a neuromodulator to treat glabellar lines.2

0

Trial Sites2,13

0

Patients13

0

Treatments13

Proven Results + High Satisfaction

Results typically seen within two days.14‡§

98%

None or mild lines3‡

The vast majority of patients achieved wrinkle severity of none or mild at week 4 per investigator's assessment.3‡

88% achieved ≥2-grade improvement at week 4 per investigator's assessment.1,3‡ 74% achieved a ≥2-grade improvement at week 4 per both investigator's and patient's assessments.1,3‡

96%

96% of patients were satisfied with their treatment at week 4.3‡
See Results

Long Lasting

DAXXIFY® lasts for a median duration of 6 months and up to 9 months for some patients.2-4,9*

SAKURA 1 1a

A chart displaying that DAXXIFY® lasts for a median duration of 6 months and up to 9 months for some patients.

SAKURA 2 1b

A chart displaying that DAXXIFY® lasts for a median duration of 6 months and up to 9 months for some patients.

None or mild: investigatorc

None or mild: patientd

74% achieved a ≥2-grade improvement at week 4 per both investigator's and patient's assessments.1,3‡

aPivotal, placebo-controlled, single-treatment trial conducted at 15 sites over 36 weeks; N=303 (DAXXIFY®: 201; placebo: 102).1

bPivotal, placebo-controlled, single-treatment trial conducted at 15 sites over 36 weeks; N=306 (DAXXIFY®: 205; placebo: 101).1

cProportion of patients from SAKURA 1 and SAKURA 2 rated as 0 or 1 (none or mild) by the investigator.1

dProportion of patients from SAKURA 1 and SAKURA 2 rated as 0 or 1 by the patient.1

Safety

Per clinical trials, DAXXIFY® is generally safe and well tolerated, with no serious treatment-related adverse events reported.1,3

ADVERSE REACTIONS ≥1% AND MORE FREQUENT THAN PLACEBO IN SAKURA 1 AND SAKURA 2 (POOLED)1

DAXXIFY®

n=406

n (%)

PLACEBO

n=203

n (%)

HEADACHE

26 (6%)

4 (2%)

EYELID PTOSIS

9 (2%)

0 (0%)

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.1,15

Info Icon The incidence of these adverse reactions did not increase with multiple treatments.1

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.16

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.1,13 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.1

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

*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. 5% of patients in SAKURA 1 and 3% of patients in SAKURA 2 had none or mild frown lines at 9 months per investigator’s assessment. In SAKURA 1, SAKURA 2, and SAKURA 3 OLS Treatments 1 and 2, 7.5%, 5.4%, 17.4%, and 11.6% of patients, respectively, had not returned to baseline severity at 9 months per both investigator’s and patient’s assessments. Conventional neuromodulator treatments last 3-4 months.2,4,9
†Based on in vitro data.12
‡Per pooled data from SAKURA 1 and SAKURA 2.1,3
§Based on patient diary data from SAKURA 1 and SAKURA 2.
|| Preservative-free.
¶Per pooled data from SAKURA 1 and SAKURA 2.74% achieved a ≥2-grade improvement at week 4 per both investigator’s and patient’s assessments.1,3

REFERENCES

1. DAXXIFY®. Prescribing Information. Revance Therapeutics, Inc; 2022.
2. 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. 2021;47(1):48-54.
3. 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.
4. 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.
5. BOTOX® Cosmetic. Prescribing Information. Allergan Inc; 2021.
6. XEOMIN®. Prescribing Information. Merz Pharmaceuticals GmbH; 2021.
7. DYSPORT®. Prescribing Information. Ipsen Biopharm Ltd; 2020.
8. JEUVEAU®. Prescribing Information. Evolus, Inc; 2019.
9. Data on File. Protocols 1620301-303. Post Hoc Analysis. Newark, CA: Revance Therapeutics, Inc, 2021.
10. Data on File. The Harris Poll Facial Injectables Landmark Survey Results. Newark, CA: Revance Therapeutics, Inc, 2018.
11. Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011;683:553-572.
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. 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.
14. Data on File. D220801001. Newark, CA: Revance Therapeutics, Inc, 2022.
15. Data on File. Sak_1_and_Sak_2_facial paresis-asymmetry. Newark, CA: Revance Therapeutics, Inc, 2019.

16. Data on File. D220801002. Newark, CA: Revance Therapeutics, Inc, 2021.

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