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Clinical Studies

Dermatologic Surgery November 2019 - Volume 45 - Issue 11 cover Dermatologic Surgery November 2019 - Volume 45 - Issue 11 cover

Volume 45 – Issue 11

November 2019

Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies

BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.

OBJECTIVE To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines...

Aesthetic Surgery Journal April 2020 - Volume 40 - Issue 4 cover Aesthetic Surgery Journal April 2020 - Volume 40 - Issue 4 cover

Volume 40 – Issue 4

April 2020

A Multicenter, Randomized, DoubleBlind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients

BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.

OBJECTIVE The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines...

Dermatologic Surgery

November 2019 – Volume 45 – Issue 11

Dermatologic Surgery November 2019 - Volume 45 - Issue 11 cover Dermatologic Surgery November 2019 - Volume 45 - Issue 11 cover

Efficacy and Safety of PrabotulinumtoxinA for the Treatment of Glabellar Lines in Adult Subjects: Results From 2 Identical Phase III Studies

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BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.

OBJECTIVE To investigate the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines.

MATERIALS AND METHODS Adult subjects (n = 330 in EV-001; n = 324 in EV-002) with moderate to severe glabellar lines at maximum frown on the 4-point Glabellar Line Scale (GLS; 0 = no lines, 1 = mild, 2 = moderate, and 3 = severe) were enrolled in 1 of 2 identical 150-day, double-blind, placebo-controlled, single-dose, Phase III studies. Subjects were randomized 3:1 to receive 20-U prabotulinumtoxinA or placebo. The primary efficacy end point was the proportion of responders on Day 30 where the investigator and subject independently agreed that a ≥2-point improvement had occurred on the GLS at maximum frown from Day 0. Adverse events (AEs) were evaluated throughout the study.

RESULTS Responder rates in the prabotulinumtoxinA and placebo groups were 67.5% and 1.2% in EV-001 and 70.4% and 1.3% in EV-002; absolute differences between groups were 66.3% and 69.1% in EV-001 and EV-002, respectively (both p < .001). No serious AE in either study was assessed as study drug related.

CONCLUSION In these studies, a single dose of 20-U prabotulinumtoxinA was safe and effective for the treatment of glabellar lines.

Aesthetic Surgery Journal

April 2020 – Volume 40 – Issue 4

Aesthetic Surgery Journal April 2020 - Volume 40 - Issue 4 cover Aesthetic Surgery Journal April 2020 - Volume 40 - Issue 4 cover

A Multicenter, Randomized, Double Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients

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BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin Type A produced by Clostridium botulinum.

OBJECTIVE The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines.

METHODS This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30.

RESULTS Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [−1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than −10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related.

CONCLUSION A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

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IMPORTANT SAFETY INFORMATION FOR JEUVEAU® (prabotulinumtoxinA-xvfs)

JEUVEAU® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU®:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.