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Culture + Careers

Nuceiva^®

(prabotulinumtoxinA)

NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.^1
‍1. Approved Nuceiva Product Information

NUCEIVA should only be administered by healthcare practitioners with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.

See Clinical Studies

PBS Information: This product is not listed on the PBS.

▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
Please review the full Product Information before prescribing. Product Information is available from https://www.ebs.tga.gov.au or by calling 1800 749 137.

Licensed in 35 Countries^3-7

Neuromodulator Treatment

Acts in 2 days^1,2

At day 2, the percentages of responders in each of the Nuceiva^®, Botox^® and placebo groups were 54.2%, 57.0%, and 12.2%, respectively. The test of superiority of Nuceiva^® vs placebo was highly statistically significant: the absolute difference in the percentages of responders was 41.9% (P < 0.001).

Lasts up to 4 months^2,3

Nuceiva^® injections significantly reduced the severity of glabellar lines by 1 point or greater at maximum frown for up to 139 days, as measured by the investigator assessment of glabellar line severity at maximum frown.

High patient satisfaction 94.5%^1,2

Percentage of patients with a positive response (improved/much improved) on the Global Aesthetic Improvement Scale (GAIS) by patient assessment (PA) by visit (Per Protocol population) ET, early termination. The percentages of responders in each of the Nuceiva^®, Botox^® and placebo groups were 94.5%, 93.4%, and 8.3%, respectively. Most randomised patients (527/540, 97.6%) qualified for inclusion in the PP population. The test of superiority of Nuceiva^® vs placebo was highly statistically significant: the absolute difference in the percentages of responders was 85.0% (P < 0.001).

1.

Australian Product Information – Nuceiva®(prabotulinumtoxina) powder for solution for injection

2.

Rzany B, et al. Aesthet Surg J. 2020;40(4):413-429

3.

Australian Public Assessment Report for Nuceiva. Sep 2023. Available from https://www.tga.gov.au/sites/default/files/2023-09/auspar-nuceiva-230919.pdf

4.

Food and Drug Administration. Department of Health and Human Services. Biologics License Application 761085. Available from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761085Orig1s000ltr.pdf

5.

uropean Commission. Granting Marketing Authorisation of Nuceiva in the European Union. 27 September 2019. Available from https://ec.europa.eu/health/documents/community-register/2019/20190927145002/dec_145002_en.pdf

6.

HRES Gov Canada. Product Monograph Nuceiva. Last reviewed 2018. https://pdf.hres.ca/dpd_pm/00046932.PDF (Accessed July 2024)

7.

Switzerland approval letter (16/11/2019) https://www.swissmedic.ch/dam/swissmedic/de/dokumente/zulassung/swisspar/69120-nuceiva-01-swisspar-20240202.pdf.download.pdf/SwissPAR%20Nuceiva.pdf

Injecting Nuceiva

Please first refer to the Nuceiva approved Product Information for administration contraindications, precautions, warnings and instructions. NUCEIVA should only be administered by healthcare practitioners with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.

See The Results

Day 0 & Day 30

Day 2

Day 30

Day 120

Day 0 & Day 30

Day 2

Day 30

Day 120

Arielle

Arielle

Arielle

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Arielle

Arielle

Arielle

Arielle

Arielle

Arielle

David

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David

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David

David

David

David

David

David

Sarah

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Sarah

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Sarah

Sarah

Sarah

Sarah

Sarah

Sarah

Tajah

Tajah

Tajah

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Tajah

Tajah

Tajah

Tajah

Tajah

Tajah

Lisa

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Lisa

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Lisa

Lisa

Lisa

Lisa

Lisa

Lisa

Tia

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Tia

Tia

Tia

Tia

Tia

Tia

Shai

Shai

Shai

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Shai

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Shai

Shai

Shai

Shai

Tugba

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Tugba

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Josephine

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Josephine

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Josephine

Josephine

Josephine

Josephine

Arielle

David

Sarah

Tajah

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Josephine

At maximum frown. Actual patient. Results may vary.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

Arielle

David

Sarah

Tajah

Lisa

Tia

Shai

Tugba

Josephine

At maximum frown. Nuceiva^® patient. Individual results may vary.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician-and patient-rated improvement in frown lines at Day 30.₂

In a study conducted in Europe and Canada, 54% of Nuceiva patients had a ≥1-grade improvement in frown lines at Day 2 based on physician assessment compared to 12% for placebo (secondary endpoint).₁ In US studies, 46% and 56% had a ≥1-grade improvement in frown lines at Day 2 based on physician-assessment compared to 8% and 17% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be considered clinically meaningful.

In 2 identical US pivotal phase III studies, 68% and 70% of Nuceiva patients had a 2-point or better physician- and patient-rated improvement in frown lines at Day 30, compared to 1% for placebo.₂

In a study conducted in Europe and Canada, 58% of Nuceiva patients had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 13% for placebo (exploratory endpoint).₁ In US studies, 65% and 57% had ≥1-grade improvement in frown lines at Day 120 based on physician assessment, compared to 8% and 13% for placebo (exploratory endpoint).₂ Results based on a 1-grade improvement may not be clinically meaningful.

References

1.

Rzany BJ, Ascher B, Avelar RL, et al. A multicenter, randomized, double-blind, placebo-controlled, single-dose, phase Phase Ill, non-inferiority study comparing prabotulinumtoxinA and onabotulinumtoxinA for the treatment of moderate to severe galabellar lines in adult patients. Aesthet Sura J. 2020:40(4):413-429.

2.

Beer KR, Shamban AT, Avelar RL, Gross JE, Jonker A. Efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines in adult subjects: results from 2 identical phase 3 studies. Dermatol Surg. 2019;45 (11):1381-1393.

Adverse events should be reported

Healthcare professionals are asked to report any suspected adverse reactions to the Therapeutic Goods Administration at www.tga.gov.au/reporting-problems and to Evolus at EvolusAustraliamedinfo@druginfo.com or 1800749137.

Adverse events should also be reported to Evolus International Ltd.

Nuceiva^® (prabotulinumtoxinA)

Performance Now Reinforced With New Data

See how Nuceiva performed in a new first-of-its kind comparative study using dynamic 3D photogrammetry.