A prospective, randomized, double-blind, placebo-controlled, two-stage, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity in children and adolescents with cerebral palsy - M602011072

Start Date06 May 2024

Sponsor / Collaborator

Merz Pharmaceuticals GmbH

NCT05980559 / Not yet recruitingPhase 3IIT

Evaluation of Botulinum Toxin Injection in Treatment of Bruxism

Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism.
The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment

Start Date15 Jan 2024

Sponsor / Collaborator

Alexandria University

NCT06091020 / RecruitingPhase 2

A Parallel-group Treatment, Proof-of-concept Phase 2, Multicenter, Double-blind, Randomized Two-arm Clinical Trial to Investigate the Efficacy and Safety of Subcutaneous NT 201 Injections Compared With Placebo Injections in Decreasing Pain Intensity in Male and Female Participants Aged 18 Years and Older With Moderate to Severe Chronic Peripheral Neuropathic Pain Due to Postherpetic Neuralgia or Peripheral Nerve Injury

In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo.
Trial details include:
Trial duration: 22-23 weeks;
Treatment duration: 1 injection visit with a 20-week follow-up period;
Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).

Start Date22 Nov 2023

Sponsor / Collaborator

Merz Therapeutics GmbH

100 Clinical Results associated with Incobotulinum toxinA (Biotecon)

100 Translational Medicine associated with Incobotulinum toxinA (Biotecon)

100 Patents (Medical) associated with Incobotulinum toxinA (Biotecon)

467

Literatures (Medical) associated with Incobotulinum toxinA (Biotecon)

01 Feb 2024·Canadian journal of ophthalmology. Journal canadien d'ophtalmologie

Patient-reported outcomes following a break in ophthalmic botulinum toxin therapy during the COVID-19 pandemic

Article

Author: Favor, Maribel ; Jamison, Aaron ; Malhotra, Raman

OBJECTIVE:

To evaluate the effect of a break in botulinum toxin treatment, necessitated by the COVID-19 pandemic, on patients' quality of life.

METHODS:

Prospective cohort study of all patients undergoing incobotulinumtoxinA treatment in our department-for benign essential blepharospasm (BEB), hemifacial spasm (HFS), aberrant facial regeneration (AFR), or crocodile tears-who were affected by the break in service (March 18, 2020-June 17, 2020). All patients who received treatment both before and after the break in service were included. Data gathered included subjective patient-reported measure of "time until treatment failure" and disease rating scale scores: Blepharospasm-Dystonia Functional Disability Assessment Scale (BDFDAS; for BEB, HFS, and AFR); Jankovic Rating Scale (JRS; for BEB and HFS); and TEARS Epiphora Grading Scale (for crocodile tears).

RESULTS:

Across 72 patients, there was a mean treatment delay of 3.9 months (range, 0-9.8 months). After a period of effect, treatment failed in all patients, with a mean time until treatment failure of 3.9 months (range, 0.5-12.0 months). All patient-reported outcome measurements increased, with greatest effect seen in AFR (178% increase in BDFDAS) and BEB (41% increase in JRS). At least 2 patients sought and underwent retreatment elsewhere in the private sector because of their symptom severity.

CONCLUSIONS:

Patients with AFR and BEB are likely to tolerate a break in service least, whereas patients with crocodile tears appear to be less affected. This real-world snapshot allows quantification of the harm caused by a break in botulinum toxin service or a treatment delay. This study provides valuable information should further breaks in service or treatment delay be considered in the future due to a further wave of COVID-19 or other reasons.

01 Jan 2024·BMJ open

Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study)

Article

Author: Bitsch, Martin Sabro ; Hørmann Thomsen, Trine ; Jensen, Rigmor Højland ; Biering-Sørensen, Bo ; Enggaard, Thomas Peter ; Klee, Marc ; Simonsen, Louise

Introduction:

Diabetic neuropathic pain (DNP) is a debilitating complication affecting 15–20% of people with diabetes and is a predictor of depression, poor sleep and decreased quality of life. Current pharmacological treatments are often insufficient and have significant side-effects. Subcutaneous or intradermal botulinumtoxin-A (BonT-A) is an effective and safe treatment for neuropathic pain but is limited by the need to cover the entire affected area with injections. For large cutaneous areas, infiltration of the sensory nerve supply with BonT-A could provide similar effects, with a single injection. We aim to investigate the safety, efficacy, and effects on quality of life, physical activity, depressive symptoms and activities of daily living of perineural injections of BonT-A in patients with DNP of both lower extremities.

Methods:

This study is a double-blind, randomised, placebo-controlled clinical trial. 80 participants with moderate to severe DNP of both legs will be randomised 1:1 to receive injections of either 100 units incobotulinumtoxin-A or a saline placebo around each distal sciatic nerve for two cycles of 12 weeks. Average daily pain scores will be recorded once a day from 1 week prior to the first treatment and through the entire study period. Primary outcomes are differences between groups in daily and weekly mean pain scores. Secondary outcomes are levels of physical activity, depression scores, health-related quality of life, activities of daily living, sensory profiles and motor function, recorded at baseline, 4, 12, 16 and 24 weeks. The use of rescue medication and adverse events will be recorded throughout the study period.

Ethics and dissemination:

The study is approved by the Danish Committee on Health Research Ethics and the Danish Medicines Agency. EU-Clinical Trial Information System (EU: 2022-500727-68-01), clinicaltrials.gov (ID:NCT05623111). Results will be published in peer-reviewed journals in open-access formats and data made available in anonymised form.

Trial registration number:

NCT05623111.

02 Nov 2023·Orbit (Amsterdam, Netherlands)

Quantitative assessment of botulinum toxin injection on blink rate in blepharospasm

Article

Author: Yazdanpanah, Ghasem ; Yen, Michael T. ; Pflugfelder, Stephen C.

PURPOSE:

To objectively measure the blink rate in patients with blepharospasm managed by botulinum toxin type-A injections.

METHODS:

In this prospective, non-interventional case series, the complete blink rates of subjects were measured before incobotulinumtoxina injection and at follow-up within 4 weeks using slow-motion video-taping. Additionally, subjects graded the frequency of blinking, the severity of light-sensitivity, and the severity and frequency of dry eye symptoms on a categorical visual analog scale. The results are reported as median (range).

RESULTS:

Ten subjects were enrolled, with nine females. The total duration of treatment was 70 (5-116) months with total of 27.5 (2-51) injections. The subjects were grouped as short-time (<52w) or long-time (>52w) treatments. The median age, follow-up time, and injected doses were 73.5 (49-81) years, 21 (14-28) days, and 38 (8-47) units, respectively, with no significant difference between groups. The total complete blinks per minute before incobotulinumtoxina injection was 39 (23-64) which decreased to 18.5 (1-60) at follow-up (p = 0.004). The average change in complete blink rate was -67.4 ± 23.7% in long-time and -45.2 ± 31.2% in short-time groups (mean ± SD, p = 0.01). The total self-graded frequency of blinking and light-sensitivity decreased significantly at follow-up (p = 0.004, p = 0.047, respectively). Similar patterns of subject reported grades were seen in both groups.

CONCLUSION:

Videotaping is a low-cost method for objective measurement of blink rate in blepharospasm patients after incobotulinumtoxina injection. There was a significant reduction in blink rate after incobotulinumtoxina injections with higher percentage of change in the long-time treatment group. Incobotulinumtoxina injection also significantly improves subjective photophobia.

News (Medical) associated with Incobotulinum toxinA (Biotecon)

17 Apr 2024

·www.biospace.com

Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for “Extra-Strength” 40U Formulation of Jeuveau®

The article published in Aesthetic Surgery Journal supports safety and duration of effect for temporary improvement in the appearance of moderate to severe glabellar lines presented at the 2023 ASDS Annual Meeting Data showed duration effect of 26 weeks, or 6 months, based on a ≥ 1-point Glabellar Line Scale (GLS) improvement and return to baseline value using the Global Aesthetic Improvement Scale NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that the Aesthetic Surgery Journal has published the safety and duration of effect results from the Phase 2 study of 40U Jeuveau® (prabotulinumtoxinA-xvfs) for the treatment of moderate to severe glabellar lines in adult patients. 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. Efficacy results demonstrated 26 weeks, or 6 months duration across the multiple metrics presented, including the time it took for patients to return to their baseline GLS score after their treatment, the duration of effect for a patient with at least a one-point GLS improvement, and the time it took a patient to return to their baseline using the Global Aesthetic Improvement Scale. The safety pro similar across all three arms and overall, 88.9% of adverse events were rated as mild and no serious adverse events were identified. “This publication provides the details of the study design along with the efficacy and safety data from the Phase 2 Jeuveau extra-strength study and makes it accessible to all,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D of Evolus. “The study confirms the correlation between increasing dose and increasing duration, while maintaining a similar safety profile, with the majority of adverse events rated as mild.” 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. Through the company’s TRANSPARENCY Clinical Program, Jeuveau® was clinically proven to temporarily improve moderate to severe glabellar lines or “11’s” in adults and included the largest head-to-head pivotal study versus BOTOX®. The product is approved for sale in the U.S. under the brand name Jeuveau® and in Europe and Canada under the brand name Nuceiva® and received regulatory approval in Australia in January 2023. About “Extra-Strength” Glabellar Line Study The “Extra-Strength” Glabellar Line Study is a multicenter, double-blind, randomized trial that followed 150 patients until they lost their correction or 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® – which were compared to 40 units of Jeuveau® in addition to evaluating the safety, efficacy, and duration of effect. About Evolus, Inc. Evolus (Nasdaq: EOLS) is a performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau® (prabotulinumtoxinA-xvfs), globally licensed under the brand name Nuceiva®. The product is manufactured in a state-of-the-art facility using Hi-Pure™ technology. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse™, a line of five unique dermal fillers currently in late-stage development. Visit us at , and follow us on LinkedIn, X, Instagram or Facebook. 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. APPROVED USE 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 or call 1-800-FDA-1088. Exclusively licensed and manufactured for: Evolus, Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660 Forward-Looking Statements This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements about future events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical or current facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The company’s forward-looking statements include, but are not limited to, statements related to market conditions and consumer demand; expectations regarding regulatory approvals, product launches, and market adoption for extra-strength formulation of Jeuveau®. The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and 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 Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, unfavorable global economic conditions and the impact on consumer discretionary spending, uncertainties related to customer and consumer adoption of Jeuveau® and Evolysse™, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse™ dermal filler product line in the U.S., our ability to maintain regulatory approvals of Jeuveau® or obtain regulatory approvals for new product candidates or indications, our reliance on Symatese to achieve regulatory approval for the Evolysse™ dermal filler product line in the U.S., and other risks described in our filings with the Securities and Exchange Commission, including in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 7, 2024. These filings can be accessed online at . Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, we undertake no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. If we do update or revise one or more of these statements, investors and others should not conclude that we will make additional updates or corrections. Jeuveau®, Nuceiva®, and Evolysse™ are trademarks of Evolus, Inc. Hi-Pure™ is a trademark of Daewoong Pharmaceutical Co, Ltd. Estyme® is a trademark of Symatese Aesthetics S.A.S.

Clinical ResultPhase 2Drug ApprovalLicense out/in

16 Apr 2024

·www.pharmaceutical-technology.com

Acorda loses Nasdaq listing to cap biotech’s end

Trading in Acorda’s stock was suspended on 12 April. Image credit: Shutterstock/NPS_87. Acorda Therapeutics has been delisted from the Nasdaq Stock Market as a result of non-compliance with Nasdaq’s listing rules. Nasdaq listing rules stipulate that companies maintain stockholders’ equity of at least $10m. As Acorda can no longer meet this requirement due to the company’s recent bankruptcy filing earlier this month, trading in the company’s common stock was suspended on 12 April, with Acorda reporting the delisting on 15 April. The absence on Nasdaq caps the company’s journey to the end of the twilight zone. The biotech’s closure date is set for 15 June, leaving the remaining 97 employees at its site in New York without a job, as per a labour notice filing . Over the past decade, Acorda saw success with its drugs for neurological disorders. Inbrija (levodopa inhalation powder) and Ampyra (dalfampridine) — also marketed as Fampyra (fampridine) outside of the US — were the company’s lead assets. Inbrija is used to treat patients with Parkinson’s disease while Ampyra/Fampyra is approved to help improve the walking ability of patients with multiple sclerosis. According to GlobalData’s Pharma Intelligence Centre, Fampyra used to see sales of more than $500m in 2017. However, after losing exclusivity to generics in 2018, Inbrija and Fampyra sales dropped to $31m and $73m respectively in 2023. See Also: Influenza [strains A/H1N1 + A/H3N2 + B/Victoria + B/Yamagata] (quadrivalent, split virion) vaccine by Sinovac Biotech for Seasonal Influenza: Likelihood of Approval INZ-701 by Inozyme Pharma for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD): Likelihood of Approval GlobalData is the parent company of Pharmaceutical Technology. Acorda struggled to balance the books as sales of its drugs weakened. Amid poor drug sales, Biogen, which had a 2009 licence agreement for Fampyra outside the US, exercised an option to the rights to Acorda earlier this year. Acorda responded to financial difficulty by laying off much of its workforce but its share values continued to dive, with a bankruptcy filing occurring in April 2024. Merz Therapeutics, known for its Botox rival Xeomin (incobotulinumtoxinA), swooped in a day later to buy Acorda’s assets , including Inbrija and Ampyra. Merz acted as a “stalking horse” bidder, a type of bid used in cases involving bankrupt companies. As it stands, Merz is set to acquire the therapies for $185m, though this could increase if another bidder comes in at a higher price. The sale process is expected to end in June 2024.

VaccineDrug ApprovalLicense out/inAcquisition

09 Apr 2024

·www.prnewswire.com

SkinMedica® Empowers Clear Skin Confidence with a New, Modern Approach to Acne

From the makers of BOTOX® Cosmetic, two new SkinMedica® acne products help address skin blemishes and can be combined with in-office DiamondGlow® IRVINE, Calif., April 9, 2024 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced the launch of two new products from SkinMedica® by the makers of BOTOX® Cosmetic. The SkinMedica® Acne Clarifying Treatment and SkinMedica® Pore Purifying Gel Cleanser are breakthroughs in skincare, providing effective and balanced care for people with acne-prone skin. The two products, along with the SkinMedica® Pore Purifying Pro-Infusion Serum, used in-office with DiamondGlow®, complete the protocol, providing acne sufferers a continuum of products to help address their skin concerns. "Acne is the most common skin concern in the US.1 It is also the primary reason patients schedule an office visit with their provider.2 For 25 years, SkinMedica® has been dedicated to perfecting scientifically proven skincare that yields visible results," said Jasson Gilmore, Senior Vice President, U.S. Aesthetics. "The formulations of the new products continue the legacy of promoting skin health and addressing key patient concerns like acne." In clinical studies, participants who used the SkinMedica® Acne Clarifying Treatment and Pore Purifying Gel Cleanser noticed clearer skin while reporting that the products did not dry their skin out. Additionally, clinical study participants noted the treatment regimen helped calm their skin.3 The SkinMedica® approach to addressing acne focuses on efficacy while respecting the skin barrier to help break the acne cycle by balancing sebum, soothing visible redness, and preserving the microbiome. "Navigating the challenges posed by acne can be difficult, and most acne products are effective at targeting acne but ignore the impact of the ingredients on the skin barrier," said Dr. Mona Gohara, board-certified dermatologist and associate clinical professor at Yale University. "My patients often find themselves in a bind when choosing acne products that treat acne but don't compromise the skin barrier. I am excited to offer my patients these new products from SkinMedica®, which focus on sebum regulation and barrier protection to create a desirable balance of low irritation with strong efficacy." The SkinMedica® Acne Clarifying Treatment is formulated with 2% encapsulated salicylic acid, which proactively guards against future breakouts. The product also includes ingredients like niacinamide and bakuchiol, which work together to reduce the appearance of discoloration and post-acne marks while refining pores and enhancing skin tone. With each application, this treatment becomes a shield, preserving the skin's natural barrier. MSRP $66. Complementing the Acne Clarifying Treatment is the SkinMedica® Pore Purifying Cleanser, which is infused with salicylic acid, a beta-hydroxy acid, to help remove impurities while a potent blend of antioxidants and soothing botanicals like aloe and chamomile caress the skin, leaving behind a soft and refreshed canvas. MSRP $46. The new SkinMedica® products are available for purchase at SkinMedica.com and through a network of licensed physicians and medically supervised spas. To experience the SkinMedica® Pore Purifying Pro-Infusion Serum for DiamondGlow®, find a provider by visiting DiamondGlow.com. For more information follow @SkinMedica on Instagram. About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. DiamondGlow® Uses The DiamondGlow® device is a general dermabrasion device that gently removes the top layer of skin and delivers topical cosmetic serums onto the skin. DiamondGlow® Important Safety Information The DiamondGlow® treatment is not for everyone. You should not have a DiamondGlow® treatment if you have compromised skin quality. Tell your provider if you are pregnant or lactating, or if you have any medical conditions, including allergies, and if you are using topical medications on the area to be treated. Typical side effects include a scratchy, stinging sensation during the treatment and temporary tightness, redness or slight swelling after the treatment. Rare serious side effects may also occur and include severe skin irritation and allergic reactions. SkinMedica® Pro-Infusion Serums Disclaimer SkinMedica® Pro-Infusion Serums are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These products are not intended to be drugs that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA. Please talk to your provider for additional information. SkinMedica® Important Information Most SkinMedica® products are intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA. SkinMedica® Acne Clarifying Treatment is an over-the-counter drug product which is formulated and marketed pursuant to FDA's governing regulations set forth at 21 CFR Part 333 Subpart D. For more information, please talk to your provider or visit SkinMedica.com and DiamondGlow.com. To report an adverse reaction, please call Allergan at 1-800-433-8871. BOTOX® COSMETIC IMPORTANT SAFETY INFORMATION AND APPROVED USES IMPORTANT SAFETY INFORMATION BOTOX® Cosmetic 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 BOTOX® Cosmetic: 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, and trouble swallowing. BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product. There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines. BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint. Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site. Tell your doctor 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 BOTOX® Cosmetic. Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast milk). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past. Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners. Other side effects of BOTOX® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes. Approved Uses BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults. For more information refer to the Medication Guide or talk with your doctor. To report a side effect, please call Allergan at 1-800-678-1605. Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide. References: AAD () Kline. Prograde Skincare Report. 2022.(According to Kline's Physician-Dispensed Skin Care: US Perception and Satisfaction Survey 2022, physicians noted that acne was the most common skin condition that patients visit physician's office for, followed by fine lines/wrinkles, sagging skin, and pigmentation.) Data on file at SkinMedica ® SOURCE AbbVie

100 Deals associated with Incobotulinum toxinA (Biotecon)

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KEGG	Wiki	ATC	Drug Bank
-	Incobotulinum toxinA (Biotecon)	M03AX01	DB00083

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
cervical dystonia	AU	Merz Australia Pty Ltd	28 Nov 2023
Crow's feet	AU	Merz Australia Pty Ltd	28 Nov 2023
Forehead lines	AU	Merz Australia Pty Ltd	28 Nov 2023
Upper limb spasticity	AU	Merz Australia Pty Ltd	28 Nov 2023
Lower limb spasticity	GB	Merz Therapeutics GmbH	07 Jun 2023
Sialorrhea	US	Merz Pharmaceuticals LLC	03 Jul 2018
Limb spasticity	US	Merz Pharmaceuticals LLC	22 Dec 2015
Glabellar frown lines	US	Merz Pharmaceuticals LLC	20 Jul 2011
Blepharospasm	US	Merz Pharmaceuticals LLC	30 Jul 2010
Torticollis	US	Merz Pharmaceuticals LLC	30 Jul 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Intellectual Disability	Phase 3	GE	Merz Pharmaceuticals GmbH	09 Feb 2015
Intellectual Disability	Phase 3	HU	Merz Pharmaceuticals GmbH	09 Feb 2015
Intellectual Disability	Phase 3	PL	Merz Pharmaceuticals GmbH	09 Feb 2015
Intellectual Disability	Phase 3	RU	Merz Pharmaceuticals GmbH	09 Feb 2015
Intellectual Disability	Phase 3	RS	Merz Pharmaceuticals GmbH	09 Feb 2015
Intellectual Disability	Phase 3	UA	Merz Pharmaceuticals GmbH	09 Feb 2015
Brain Injuries, Traumatic	Phase 3	DE	Merz Pharmaceuticals GmbH	01 Apr 2014
Brain Injuries, Traumatic	Phase 3	PL	Merz Pharmaceuticals GmbH	01 Apr 2014
Parkinson Disease	Phase 3	DE	Merz Pharmaceuticals GmbH	01 Apr 2014
Parkinson Disease	Phase 3	PL	Merz Pharmaceuticals GmbH	01 Apr 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04594213 (CTgov)	Phase 3	-	362	Placebo (Main Period: Placebo (Group P))	sotsirxxzz(ovzitcszcf) = szulhfdcjf ndpmarcsmw (bxyvvfqwun, yrukhkfutn - lufdnrjjjb) View more	-	08 May 2024
				NT 201 (Main Period: NT 201 (Group U))	sotsirxxzz(ovzitcszcf) = hqisdrsvgm ndpmarcsmw (bxyvvfqwun, xberxemvst - bbsjlzkfxq) View more
NCT03806933 (CTgov)	Phase 2	-	241	MP+NT 201 (Stage 1 and 2 Pooled: NT 201 20 U)	mnhgnxczrm(kohrptzstr) = xmgaabbkbq smuvzyizfn (inydziwxwu, mequrylbfp - nbomdnlrmw) View more	-	04 Oct 2023
				MP+NT 201 (NT 201 50 U)	mnhgnxczrm(kohrptzstr) = skubzfnrua smuvzyizfn (inydziwxwu, mlwkngkgkr - ctijcfjvmk) View more
MDS2023	Not Applicable	-	451	IncobotulinumtoxinA	rmmexrhriy(mcyqmwvcyv) = cvbhdcpdkz wbzipiecyo (epzsbmnlci )	-	27 Aug 2023
				Placebo	rmmexrhriy(mcyqmwvcyv) = syoeuxxqrx wbzipiecyo (epzsbmnlci )
NCT02088632 (CTgov)	Phase 2	Trigeminal Neuralgia	6	Incobotulinumtoxina (Incobotulinumtoxina)	knqgoyihsl(kfftmtadxq) = udanzogwfe rwlolyiejy (zkckzzjmel, zuuvswhgfk - bwawnzfkid) View more	-	28 Jun 2023
				Placebo Comparator (Placebo Comparator)	knqgoyihsl(kfftmtadxq) = aqaaaqcpxu rwlolyiejy (zkckzzjmel, zavebffvvy - buoywjgkik) View more
P14-11.008 (AAN2023)	Phase 2/3	Limb spasticity	542	IncobotulinumtoxinA	iquilsitrn(ebaagljjbr) = fbqwznerfh nednhhpabm (drdfxhxdks ) View more	Positive	25 Apr 2023
				Placebo	iquilsitrn(ebaagljjbr) = ydibnofzzv nednhhpabm (drdfxhxdks ) View more
P12-11.009 (AAN2023)	Phase 2/3	Limb spasticity	515	incoA injections	gnfkdhsttp(xexqsujjsf) = rdhuidlrrs ubzkyctjhg (pwnevyoyty ) View more	-	25 Apr 2023
NCT04148872 (CTgov)	Phase 4	Facial Paralysis \| Synkinesis	15	Neuromuscular Retraining + Chemodenervation (Neuromuscular Retraining Therapy)	htuwmitksf(sdbikbjvmx) = lmxwveagzo orfusbsgnp (xqcqifbhwp, uvkiocldaf - vznxloevat) View more	-	29 Sep 2022
				Chemodenervation (4 months) (Chemodenervation)	htuwmitksf(sdbikbjvmx) = qthltpahmn orfusbsgnp (xqcqifbhwp, ryxhwgiunb - wwboftdxkk) View more
MDS2022	Phase 2/3	Limb spasticity	542	IncobotulinumtoxinA	ykdmankmih(wxkwlveljb) = ozwyiieprp jqbqobqufd (cyawcnswgp ) View more	Positive	15 Sep 2022
				Placebo	ykdmankmih(wxkwlveljb) = qxnxlyyfzt jqbqobqufd (cyawcnswgp ) View more
MDS2022	Phase 2/3	Limb spasticity	515	IncobotulinumtoxinA	zlfovyulro(iqwwljaecq) = ehxpprllpe rfoshujswa (fmbnewyqds )	-	15 Sep 2022
NCT02002884 \| NCT01905683 \| NCT02270736 \| NCT01893411 (Pubmed)	Phase 3	Muscle Spasticity \| Sialorrhea	1,159	IncobotulinumtoxinA	njtagplflw(rdvuleseae) = szhlfahqgr ebzrjgpcwj (zzkvskszoe ) View more	-	25 Aug 2022

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