Myobloc (rimabotulinumtoxin B) / Supernus Pharma, Eisai - LARVOL DELTA

Long-Term Safety and Efficacy of Repeated Cycles of RimabotulinumtoxinB in the Treatment of Chronic Sialorrhea: Results of the OPTIMYST Trial. (PubMed, Neurol Ther) - P3 | "This study demonstrates that RIMA 3500 U safely reduces saliva production over repeated treatment cycles through 1 year, thereby supporting its utility in the management of troublesome sialorrhea in adults."

Clinical • Journal • Amyotrophic Lateral Sclerosis • CNS Disorders • Dental Disorders • Movement Disorders • Parkinson's Disease • Xerostomia

Successful Treatment of Sialorrhea with Daxibotulinum Toxin A (AAN 2025) - "Currently, IncobotulinumtoxinA (USA and Europe) and RimabotulinumtoxinB (USA) are approved for this indication. All surveys suggest DaxibotulinumtoxinA provided sustained improvement of sialorrhea and may provide a novel alternative option for those refractory to other treatments."

CNS Disorders • Movement Disorders • Parkinson's Disease

High-Dose Rimabotulinumtoxin B for Chronic Sialorrhea: A Case Report on the Safety and Efficacy of 20,000 Units Injection. (PubMed, Toxicon) - "So far, the patient has received 22 treatment cycles of high-dosage RIMA spaced three months apart with remarkable improvement in sialorrhea without any severe adverse effects. This case demonstrates the potential safety and efficacy of using RIMA at a dose of 20,000 units for managing refractory chronic sialorrhea in patients with cerebral palsy, warranting further research into higher dosing regimens."

Journal • Cerebral Palsy • CNS Disorders • Developmental Disorders • Mental Retardation

Do Lower Doses of Botulinum Neurotoxin Type-A Offer a Longer Duration of Effect and Superior Efficacy in Patients with Cervical Dystonia? (MDS Congress 2024) - "Background: Recently, a long-acting neurotoxin, daxibotulinumtoxinA, was approved for cervical dystonia (CD)...Patients with a history of essential tremor, who previously received rimabotulinumtoxinB, or received injections for multiple indications, were excluded from the study. The cutoff between low-dose and high-dose groups was 220 units for those who received either onabotulinumtoxinA or incobotulinumtoxinA and 500 units for those who received abobotulinumtoxinA... Our preliminary data showed that patients administered a lower dose of BoNT-A reported a longer duration of effect and superior efficacy compared to those who received a higher dose. While a potential explanation for our result is a greater disease burden in patients requiring higher doses, it is also possible that there is a ceiling effect, and we are unnecessarily overdosing patients."

Clinical • CNS Disorders • Dystonia • Essential Tremor

Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | N=108 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Pediatrics

RimabotulinumtoxinB: An Update. (PubMed, Dermatol Surg) - "Type B toxin has demonstrated its safety and efficacy in treating facial rhytids, cervical dystonia, sialorrhea and hyperhidrosis, with potential for novel applications under investigation. Regardless of injection location and clinical applications, dry mouth and dysphagia remained the most common side effects. Across all indications, type B toxin appeared to have a faster onset of action, a dose-dependent clinical duration, and a dose-dependent adverse effect profile."

Journal • Review • CNS Disorders • Dermatology • Dystonia • Gastrointestinal Disorder • Movement Disorders • Xerostomia

Using Neuromodulators for Salivary, Eccrine, and Apocrine Gland Disorders. (PubMed, Dermatol Surg) - "Neuromodulators are safe and effective for the noninvasive treatment of excess gland activity and can improve patients' quality of life. While substantial literature supports botulinum toxin treatments for hyperhidrosis, further studies are needed to characterize standard dosing and administration techniques for sialorrhea, bromhidrosis, and chromhidrosis."

Journal • Review • Dermatology

Botulinum Toxin for Scalp Conditions: A Systematic Review (AAD 2024) - "Where specified, formulations of botulinum toxin used for scalp conditions included onabotulinumtoxinA, Chinese botulinum toxin type A, abobotulinumtoxinA, prabotulinumtoxinA, and rimabotulinumtoxinB. Botulinum toxin may be a promising therapeutic option for patients with various scalp conditions, but future studies are needed to better understand its efficacy and safety. Disclosure: The U.S. Food and Drug Administration has not yet approved the use of botulinum toxin for the conditions discussed in this abstract."

Review • Alopecia • Dermatology • Fibrosis • Immunology • Pain • Scleroderma • Seborrheic Dermatitis • Systemic Sclerosis

Botulinum Toxin A and B for Palmoplantar Hyperhidrosis. (PubMed, Dermatol Ther (Heidelb)) - "We found that BTX-A and BTX-B treatment for palmar hyperhidrosis and BTX-B treatment for plantar hyperhidrosis led to a substantial improvement of QoL."

Journal • Dermatology

Patient Characteristics and Real-World Use of Botulinum Neurotoxins for Treatment of Cervical Dystonia and Blepharospasm (TOXINS 2024) - "Prior onabotulinumtoxinA use was identified in 31% and 44% of incobotulinumtoxinA users with CD and BLEPH, respectively. Use of rimabotulinumtoxinB or abobotulinumtoxinA was relatively less common in these populations...Use of multiple BoNT formulations was relatively common. The prevalence of co-medications suggests that management of symptoms of CD and BLEPH involve other therapies beyond BoNT."

Clinical • Real-world • Real-world evidence • CNS Disorders • Dystonia • Movement Disorders

Supernus Resident Theater: MYOBLOC® for Cervical Dystonia in Adults (AAPMR 2023) - "Sponsored by: Supernus"

Clinical • CNS Disorders • Dystonia • Movement Disorders

Patient characteristics and real-world use of botulinum toxins for treatment of cervical dystonia and blepharospasm (MDS Congress 2023) - "Prior onabotulinumtoxinA use was identified in 31% and 44% of incobotulinumtoxinA users with CD and BLEPH, respectively. Use of rimabotulinumtoxinB or abobotulinumtoxinA was relatively less common in these populations.; This claims-based study provides insight into the characteristics of insured patients with CD and BLEPH treated with BoNT... This claims-based study provides insight into the characteristics of insured patients with CD and BLEPH treated with BoNT. Patients are commonly Non-Hispanic White female patients ≥45 years of age. Use of multiple BoNT formulations was relatively common."

Clinical • Real-world • Real-world evidence • CNS Disorders • Dystonia

Botulinum Toxin Off Label Use in Chronic Migraine Patients: An American Headache Society Clinical Survey Study (AHS 2023) - "In terms of off-lablel BTX use, 16.1% have used incobotulinumtoxinA, followed by abobotulinumtoxinA (13.1%) and rimabotulinumtoxinB (6.6%). Alternative toxins are not used by the majority of headache providers for the treatment of CM. When used, however, (1) incobotulinumtoxinA is the most commonly used alternative toxin, (2) it is due to administrator/payer request, and (3) most clinicians feel it is as effective as onabotulinumtoxinA. Limitations of this study include low survey responder rate."

Clinical • CNS Disorders • Migraine • Pain

Botulinum Toxin Off Label Use in Chronic Migraine Patients: An American Headache Society Clinical Survey Study (AAN 2023) - "In terms of off-lablel BTX use, 16.1% have used incobotulinumtoxinA, followed by abobotulinumtoxinA (13.1%) and rimabotulinumtoxinB (6.6%). When used, however, (1) incobotulinumtoxinA is the most commonly used alternative toxin, (2) it is due to administrator/payer request, and (3) most clinicians feel it is as effective as onabotulinumtoxinA. Limitations of this study include low survey responder rate."

Clinical • CNS Disorders • Migraine • Pain

Botulinum toxin for Sialorrhea in Patients with Parkinson’s disease & Atypical Parkinsonism: A Single Center Real-World Study (AAN 2023) - "Background RimabotulinumtoxinB and IncobotulinumtoxinA are FDA approved for the treatment of medically refractory sialorrhea. 103 (92%) of patients reported no dysphagia or worsening of preexisting dysphagia after injections while 8 (8%) reported mild dysphagia after injection which resolved in a few weeks. Conclusions In this large ‘real world’ study of patients with PD, with and without DBS, AP, BTX was well tolerated and resulted in patient reported “much improvement” of medically refractory sialorrhea."

Clinical • Real-world • Real-world evidence • CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity (clinicaltrials.gov) - P2/3 | N=272 | Active, not recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Cerebral Palsy • CNS Disorders • Movement Disorders • Multiple Sclerosis • Orthopedics • Vascular Neurology

Efficacy and Safety of Botulinum Toxin B in Focal Hyperhidrosis: A Narrative Review. (PubMed, Toxins (Basel)) - "Botulinum toxin type B (BoNT-B), known as Myobloc in the United States and as Neurobloc in Europe, is a new therapeutically available serotype among the botulinum toxin family...Moreover, recent studies have been examining its safety profile, which may be different from those known about BoNT-A. The aim of this review is to provide information about what is currently known about BoNT-B in regards to the treatment of focal hyperhidrosis."

Journal • Review • Dermatology

Botulinum toxin in the treatment of residual limb hyperhidrosis: A systematic review. (PubMed, Rehabilitacion (Madr)) - "The search terms used were "botulinum toxins", "botulinum toxins, Type A", "rimabotulinumtoxinB", "amputees", "amputation stumps", "amputation" and "residual limbs"...The results demonstrated an improvement in residual limb hyperhidrosis in all studies. Botulinum toxin A or B can be regarded as safe and effective for the treatment of residual limb hyperhidrosis, as well as improving prosthesis use and quality of life."

Journal • Review • Dermatology

Botulinum Toxin Therapy for Medication and DBS Refractory Foot Dystonia of Parkinsonism (MDS Congress 2022) - "Types of BTX injected included onabotulinumtoxin A, incobotulinumtoxin A, and rimabotulinumtoxin B. Injections were repeated if a satisfactory response was noted Seventy three patients (29 male, 44 female) were included. In this large cohort, BTX treatment was well tolerated and resulted in patient-reported meaningful improvement in foot dystonia secondary to PD and AP. PD patients who had refractory foot dystonia despite DBS also reported similar improvement"

CNS Disorders • Dystonia • Parkinson's Disease

Temporary Botulinum Immobilization of Residuum Muscles for Facilitation of the Initial Ingrowth of Skin to the Porous Skin and Bone Integrated Pylon in the Technology of Direct Skeletal Attachment: Large Animal Model. (PubMed, Front Rehabilit Sci) - "We found that injections in the four muscles of the distal thigh of the left hind leg with MYOBLOC® (rimabotulinumtoxinB; 5,000 units/muscle) were sufficient to provide noticeable immobilization by the fourth week after the procedure. This conclusion was made based on the analysis of the dynamics of asymmetry in vertical ground reactions on the injected (left hind) and uninvolved (right hind) legs during gait over an instrumented walkway."

Journal • Preclinical • Infectious Disease

Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Pediatric Subjects (clinicaltrials.gov) - P3 | N=108 | Not yet recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Initiation date: Nov 2021 ➔ Nov 2022

Trial initiation date • Pediatrics

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity (clinicaltrials.gov) - P2/3 | N=272 | Recruiting | Sponsor: Supernus Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Cerebral Palsy • CNS Disorders • Movement Disorders • Multiple Sclerosis • Orthopedics • Vascular Neurology

Safety and Efficacy of Rimabotulinumtoxin B in Patients with Cervical Dystonia in Observational Study (PubMed, Brain Nerve) - "The efficacy did not decrease substantially with an increased number of doses; the efficacy shown as the total of "significantly improved" and "improved" in clinical global impression up to 12 doses in at least 100 patients was around 45%, indicating an efficacy similar to type A. The efficacy at final observation shown as total of "significant improved" and "improved" was 38.5%, while the total of these and "moderately improved" was 76.9%. There was no significant difference in efficacy with different maximum doses of the product, with a dose as low as 5000 IU≤ thought to be effective in some patients."

Clinical • Journal • Observational data • CNS Disorders • Dystonia • Gastrointestinal Disorder • Movement Disorders • Pain • Xerostomia

Efficacy of botulinum toxin type B (rimabotulinumtoxinB) in patients with cervical dystonia previously treated with botulinum toxin type A: A post-marketing observational study in Japan. (PubMed, eNeurologicalSci) - "Improvements were maintained through six further injections in two subpopulations: patients who showed resistance to botulinum toxin type A and patients who were not type A resistant but switched to type B. For a number of patients, even low doses (<5000 units) of botulinum toxin type B demonstrated efficacy. These findings support the efficacy of botulinum toxin type B in clinical settings for the management of CD symptoms, including pain, even at low doses, regardless of the patient's botulinum toxin type A resistance status."

Clinical • Journal • Observational data • P4 data • CNS Disorders • Dystonia • Movement Disorders • Pain

A Unique Presentation of Aperistalsis of the Esophagus Secondary to Myobloc Injection (ACG 2021) - "Our patient’s injection resulted in aperistalsis of the esophagus and feeding tube placement. Treatment consisted of symptomatic management, dietary changes, and endoscopic interventions while waiting for the effect of the toxin to dissipate."

CNS Disorders • Dystonia • Gastrointestinal Disorder • Migraine • Movement Disorders • Pain • Rheumatology • Xerostomia