Incobotulinum toxinA (Biotecon)

OnabotulinumtoxinA (BOTOX®) met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo.1 The trial also met all six secondary endpoints.2 Results from safety analyses were generally consistent with the well-established safety profile of onabotulinumtoxinA.1 NORTH CHICAGO, Ill., Oct. 6, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared to placebo for the treatment of upper limb essential tremor. The study met its primary endpoint, demonstrating statistically significant improvements in the Tremor Disability Scale-Revised (TREDS-R) of onabotulinumtoxinA compared to placebo at week 18. Specifically, the onabotulinumtoxinA group showed a greater reduction in TREDS-R total unilateral score compared to placebo, with scores of -2.61 versus -1.61, (p=0.029).1 The study also met all six secondary endpoints.2 "Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments," said Daniel Mikol, M.D., Ph.D., vice president, neuroscience development, AbbVie. "No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition." Safety results were generally consistent with the well-established safety profile of onabotulinumtoxinA. Muscular weakness was the most common adverse event, with reported rates of 24.5% in the onabotulinumtoxinA group versus 2.3% in the placebo group. Instances were localized and transient and most were classified as mild or moderate in nature.1 Results from the study will be presented at the International Congress of Parkinson's Disease and Movement Disorders® on October 8, 2025. The use of BOTOX® for essential tremor is not approved by the U.S. Food and Drug Administration (FDA) or any other global regulatory authority and its safety and efficacy have not been evaluated by regulatory authorities. About the ELATE Study The ELATE trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of upper limb essential tremor in adults. The primary efficacy measure was the change in the Tremor Disability Scale-Revised (TREDS-R) total score across seven unilateral items from baseline across weeks 15, 18 and 21. Secondary outcome measures included activity of daily living assessment, various tremor assessment scales and global impression of severity scores. More information on the ELATE trial can be found on www.clinicaltrials.gov. About Essential Tremor Essential tremor is the most common movement disorder, impacting approximately 25–60 million individuals worldwide.3 This condition complicates physical activities due to uncontrollable and involuntary action tremors and furthermore often results in depression, anxiety and social embarrassment, thereby affecting overall quality of life.4 Current treatment options are limited in both efficacy and tolerability often leaving patients with few viable options. About BOTOX® (onabotulinumtoxinA) BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for multiple therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to detrusor overactivity associated with a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis). BOTOX® is not FDA-approved for essential tremor. BOTOX® (onabotulinumtoxinA) Important Information U.S. Indications BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used: To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older To treat increased muscle stiffness in people 2 years of age and older with spasticity To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older. It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine). BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits. U.S. IMPORTANT SAFETY INFORMATION BOTOX 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: 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 preexisting 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; drooping eyelids; hoarseness or change or loss of voice; trouble saying words clearly; loss of bladder control; trouble breathing; and trouble swallowing. There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus. BOTOX may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Do not receive BOTOX if you are allergic to any of the ingredients in BOTOX (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo® (letibotulinumtoxinA-wlbg) (this may not be a complete list of all botulinum toxin products); have a skin infection at the planned injection site. Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment. Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics. Adult patients treated for overactive bladder due to a neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC postinjection than those with spinal cord injury. The dose of BOTOX is not the same as, or comparable to, another botulinum toxin product. Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX should be discontinued. 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. Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX. Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch. Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX. Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo. Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively). Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX 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 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 in the past. Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, Xeomin®, Jeuveau®, Daxxify®, or Letybo® in the past (this may not be a complete list of all botulinum toxin products; 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 include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI; bacteria, white blood cells, and blood in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again. For more information, refer to the Medication Guide or talk with your doctor. 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. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. 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 including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. 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, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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. AbbVie Media: Liz Tang, Ph.D. liz.tang@abbvie.com Investors: Liz Shea liz.shea@abbvie.com References: SOURCE AbbVie

DermAlign Medical Aesthetics now uses this minimally non-surgical cosmetic treatment called PDO Thread Lift as an alternative to the standard Surgical Facelift. LANGHORNE , PA, UNITED STATES, August 7, 2025 / EINPresswire.com / -- DermAlign Medical Aesthetics Removes Wrinkles with Ease August 7, 2025 DermAlign Medical Aesthetics based in Langhorne, Pa, would like to reach out to residents who may be in search of anti-aging medical spa treatments. This Med Spa offers a wide range of medical spa treatments with a special emphasis on wrinkle removal techniques. DermAlign Medical Aesthetics is a boutique med spa committed to providing exceptional cosmetic care using the latest non-surgical technologies. With a strong emphasis on natural beauty, safety, and personalized service, so whether you’re looking for Injectables, Micro-Needling, PDO Thread Lifting, Sexual Wellness, Medical Grade Weight Loss, Hair Restoration, PRP or the latest Hollywood Salmon Sperm PDRN DermAlign Medical Aesthetics has you covered. The Medical Staff at DermAlign Medical Aesthetics invests in over 100 Continuing Education hours per year ensuring that their patients receive the most advance & update treatments and thus allowing DermAlign Medical Aesthetic to be a leader in medical aesthetics field. Ekata Rushi PA-C, Founder of DermAlign Medical Aesthetics looks forward to providing quality, effective treatments to her patients. While DermAlign Medical Aesthetics mainly services the Mainline, Bryn Mawar, Bluebell, King of Prussia, New Hope, Bucks, Montgomery County PA. & Mercer & Hunterdon County NJ. “Men and women throughout the country as far as Alabama to Miami Fl. fly in to see Ekata Rushi PA-C. Patients can finally look and feel their best with the help of DermAlign Medical Aesthetics. Ekata Rushi PA-C at DermAlign Medical Aesthetics is a leading Aesthetic Medicine Physician Associate who offers her patients the latest in Wellness and Aesthetic solutions. Ekata specializes in the “30 minute nonsurgical face lift” using PDO Threads. Using the most advance Facelift techniques that she learned from the world leading plastic surgeons. So even if you’re looking for the best wrinkle removal treatments, DermAlign Med Spa utilizes many non-invasive techniques and treatments that can help remove wrinkles from the faces of our patients. One very popular option that is offered at the Med spa is the insertion of dermal fillers, which can help smooth out one’s skin and minimize the appearance of moderate to deep grooves and wrinkles. The spa uses clinically tested and proven dermal fillers from dependable producers like JUVÉDERM ® to fill in areas where the patient may have lost volume. The advanced dermal fillers used by Ekata Rushi PA-C are made to last a long time, and one can expect the effects to last up to years. While dermal fillers can boost the appearance of one’s skin on an immediate basis, it is still important to take care of one’s skin and protect it in order to lessen the effects of aging. DermAlign Medical Aesthetics offers its own Medical Grade Skin line solutions to help patients maintain the appearance of their skin. Ekata Rushi PA-C also offers her patients advice on how to avoid wrinkles. “Once Ekata Rushi PA-C gets you started on your custom anti-aging regimen you will begin to notice the benefits of injectables and Medical grade Skin products, you need to start looking at preventive skincare,” says Ekata. “Granted, you’re still going to age, so you can’t stop all wrinkles from forming. However, you can certainly work to lessen your risk of deep wrinkles and other signs of aging. The best way to prevent wrinkles is to minimize sun exposure and wear sunscreen daily. DermAlign Medical Aesthetics has an entire line of protective products that offer SPF protection. Some products are even tinted and blend in perfectly underneath your makeup. Schedule your anti-aging consultation at DermAlign Medical Aesthetics and take control of your wrinkles.” Ekata Rushi PA-C has over 14 years of Neurosurgical & Weight loss surgical and Emergency Medicine Experience. After over a decade of high-intensity medical & surgical care, she turned her attention to aesthetics, pursuing her passion for artistry and long-term patient care. Ekata lives in Newtown with her husband and two daughters and is deeply involved in the local community. At DermAlign, her mission is simple: to educate, empower, and enhance every patient’s natural beauty with safe, effective, and proven treatments. and is considered a leader in the cosmetic medicine industry. A number of Ekata patients have left excellent reviews of her work. One review on the DermAlign Medical Aesthetics GMB listing, from a patient named Edina “Omg I can’t say enough she is absolutely wonderful, check out my before and after pictures- also she called me in the evening and left me message to remind me of the aftercare needed, and the next day also to see how I was doing, you do not find anyone who will care enough to call and check on you anywhere !!! She is an amazing artist with her work; I will definitely be back also check her out on Instagram! " Another patient, Melissa “New Botox/Xeomin patient appointment today. The staff was very friendly & knowledgeable. Took their time to explain everything in detail. Didn’t feel rushed. I definitely will be returning.” Contact Information • DermAlign Medical Aesthetics • 320 Middletown Blvd, Ste 300, Langhorne, PA 19047, USA • info@dermalignmedspa.com • www.Dermalignmedspa.com EKATA RUSHI PA-C DERMALIGN MEDICAL ANESTHETICS INFO@DERMALIGNMEDSPA.COM Visit us on social media: Instagram Facebook YouTube TikTok Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.