The buzz about a new tox, Daxxify, claims results will last 6 months. This could be revolutionary in aesthetics to reduce the number of treatments needed to maintain muscle paralysis resulting in smooth, wrinkle-free skin.

What is it?

Daxxify (DaxibotulinumtoxinA-lanm) is a neurotoxin that inhibits the release of acetylcholine, the neurotransmitter which signals your muscles to contract ¹. It is produced from the bacteria Clostridium botulinum toxin A, like all other toxins currently on the market. It was recently FDA approved for treatment of glabellar lines.

What exactly did we learn from the SAKURA phase 3 clinical trial?

40U of Daxxify to the glabella (frown lines) reduced the appearance of moderate to severe lines for 27 months¹,²,³,⁴.

How was that measured?

• Patients were assessed using a 4-point scale grading their glabellar lines from a score of 0 to 3 (0: none, 1:  mild, 2: moderate, 3: severe) ¹,²,⁴
• Patients with moderate to severe rating were eligible for treatment
• Treatment of 40U to the Glabella was performed using a 5-point injection pattern. ¹,²,⁴
• Patients were reassessed at 4 weeks to determine if treatment was successful. A successful treatment was defined as a repeat score of 0: no lines or 1: mild lines AND a 2-point score decrease¹,²,⁴. The score was reported by the investigator AND the subject.
• 74% of patients had successful treatments ¹,²,⁴
• The 74% of patients were followed for at least 24 weeks. ¹,²,⁴
• Investigator and subjects report scores of 0 to 1 (no lines, to mild lines) for a median 24 weeks ¹,²,⁴
• The median time to return to baseline was 27 weeks ¹,²,⁴

Safety

Almost 2700 subjects were treated with 40U of Daxxify. Some subjects received 2 and 3 subsequent treatments ²,³. The rate of adverse reactions was 20% with most common reactions including injection site pain, redness, swelling, bruising, injection site itching, headache, and eyelid ptosis²,³. There was no increase in adverse reactions with subsequent treatments.

How do the units compare to Botox?

Dosages are not interchangeable due to the difference in formulations ¹. 40 units of Daxxify won’t equal 40 Units of Botox. So doing the conversions may get tricky.

For some reference, the recommended dose of Botox for the Glabella is 20 units. I personally inject between 15-20U of Botox depending on muscle bulk and strength. With that said we are proposing approximately 20 units of Botox = 40 units of Daxxify.

Depending on the cost, Daxxify may or may not be a better deal.

If the price per unit is double that of Botox, even though the treatment lasts twice as long, ultimately the price over 1 year remains the same. However, the convenience of treatment just twice a year may be enticing enough to cause patients to make the switch.

References

1.  Daxxify (daptobotulinumtoxinA-lanm) [package insert]: Revance Aesthetics; 2022 https://revance.com/wp-content/themes/allen-larson-theme/files/daxi-pi-and-med-guide.pdf

2.  Carruthers JD, Fagien S, Joseph JH, Humphrey SD, Biesman BS, Gallagher CJ, Liu Y, Rubio RG; SAKURA 1 and SAKURA 2 Investigator Group; SAKURA 1 and SAKURA 2 Investigator Group includes the following. 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 Jan;145(1):45-58. doi: 10.1097/PRS.0000000000006327. PMID: 31609882; PMCID: PMC6940025.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6940025/pdf/prs-145-045.pdf

3.  Green JB, Mariwalla K, Coleman K, Ablon G, Weinkle SH, Gallagher CJ, Vitarella D, Rubio RG. 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 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463. PMID: 32773447; PMCID: PMC7752221. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7752221/

4. Efficacy and safety of daxibotulinumtoxina for injection to treat moderate to severe glabellar lines – study results. Study Results – ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/results/NCT03014622. Accessed September 18, 2022.