"Extra-Strength" Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Interim Phase II Data Results, Representing Prolonged 6-Month Performance
- “Extra-strength” 40U formulation achieves one-point improvement on the Glabellar Lines Scale with the duration of effect lasting 26 weeks, representing a prolonged 6-month performance
- Results indicate a favorable safety profile; no serious adverse events reported and 88% of all adverse events were mild
- Potential new “extra-strength” formulation would expand
- Trial completion expected mid-2023; final results anticipated to be presented in 2H 2023
The extra-strength glabellar line study is a multicenter, double-blind, randomized Phase 2 trial following 150 patients for up to 12 months or until the patient loses their correction. The study has three arms: Jeuveau® Extra-Strength 40U and two active controls, Botox® 20U and Jeuveau® 20U. An interim analysis was performed to assess the safety and efficacy of the extra-strength formulation. At this time, Jeuveau® Extra-Strength has demonstrated 6 months (26 weeks) duration across the three metrics presented, including the time it takes for patients to return to their baseline Glabellar Line Scale (GLS) score after their treatment, time back to baseline for patients with a response of none or mild on the GLS, and the duration of effect of at least a one-point GLS improvement. The adverse events profile across all three arms was similar. The severity rating demonstrated that 88% of the events were mild and 12% were moderate. Importantly, no serious adverse events were reported.
“The interim results of this study are a significant step forward in our strategy to provide a longer-duration treatment option to patients, and we are very pleased that the ‘extra-strength’ formulation of Jeuveau® demonstrated a duration of 6 months or 26 weeks,” said
“The combination of results from the ‘original strength’ trials and this exciting new ‘extra-strength’ data further reinforces Jeuveau’s® efficacy, offering greater flexibility for clinicians and patients while maintaining a similar safety profile between the two formulations,” said
Jeuveau® is approved for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) in adults below 65 years of age. The safety and efficacy of Jeuveau® was evaluated through the company’s TRANSPARENCY program, the largest head-to-head pivotal study versus BOTOX® to date. The product is approved for sale in the
About “Extra-Strength” Glabellar Line Study
The “Extra-Strength” Glabellar Line Study is a multicenter, double blind, randomized trial that is following 150 patients for up to 12 months at five study sites. The study includes two active controls – the currently approved 20 units of Jeuveau® and 20 units of BOTOX® Cosmetic – which will be compared to 40 units of Jeuveau®. In addition to evaluating the safety, efficacy and duration of effect, this study will also help assess the potential clinical tradeoffs for patients when using the longer duration option.
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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.
Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), or incobotulinumtoxinA (XEOMIN®); have a skin infection at the planned injection site; or are a child.
JEUVEAU dosing units are not the same as, or comparable to, any other botulinum.
Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, Myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of JEUVEAU.
Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past.
Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months, and exactly which product you received (such as BOTOX, BOTOX Cosmetic, MYOBLOC, DYSPORT, or XEOMIN).
JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
JEUVEAU can cause other serious side effects including: allergic reactions such as itching, rash, red itchy welts, wheezing, trouble breathing, asthma symptoms, or dizziness or feeling faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint. Heart problems. Irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Eye problems such as dry eye, reduced blinking, and corneal problems. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.
The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count.
JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).
The risk information provided here is not complete. For more information about JEUVEAU, see the full Prescribing Information including BOXED WARNING, and Medication Guide, visit evolus.com or talk to your healthcare provider.
To report side effects associated with use of JEUVEAU, please call 1-877-EVOLUS1/1-877-386-5871. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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The forward-looking statements included herein are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Allergan/Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, the continued impact of COVID-19 or other outbreaks of contagious diseases on our business, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, our ability to successfully broaden our product portfolio, our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications and other risks described in our filings with the
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Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
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