Lyvispah Oral Granules Approved for Spasticity Due to Multiple Sclerosis
Lyvispah is supplied as a strawberry-flavored, dissolvable granular formulation of baclofen.
Muscle Spasms
Botox Approval Expanded to Include 8 New Muscles for Upper Limb Spasticity
The indication for adult upper limb spasticity treatment now includes elbow and forearm muscles, intrinsic hand muscles, and thumb muscles.
FDA Expands Use of Botox and Dysport for Spasticity in Pediatric Patients
The FDA has approved the expanded use of Botox® (onabotulinumtoxinA; Allergan) for the treatment of spasticity in pediatric patients aged ≥2 years, including those with lower limb spasticity caused by cerebral palsy.
Novel Therapy for Progressive Supranuclear Palsy Gets Orphan Drug Designation
The FDA has granted Orphan Drug designation to RT001 (Retrotope) for the treatment of progressive supranuclear palsy (PSP).
Botox Approved for Pediatric Lower Limb Spasticity
The FDA has approved Botox for the treatment of lower limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. The treatment was already approved for pediatric upper limb spasticity earlier this year.
Dysport Indication Expanded to Include Upper Limb Spasticity Treatment in Children
The Food and Drug Administration (FDA) has expanded the indication of Dysport (abobotulinumtoxinA; Ipsen) to include the treatment of upper limb spasticity in patients aged 2 years and older, excluding spasticity caused by cerebral palsy. Previously, Dysport was only approved to treat lower limb spasticity in patients aged 2 years and older. The approval was…
Myobloc Approved for the Treatment of Chronic Sialorrhea
The Food and Drug Administration (FDA) has approved Myobloc (rimabotulinumtoxinB injection; US WorldMeds) for the treatment of chronic sialorrhea in adults. The approval was based on multiple studies, including a double-blind, placebo-controlled trial, followed by an open-label treatment period, in 187 patients with chronic, troublesome sialorrhea for at least 3 months. Patients were randomized to…
Botox Approved to Treat Pediatric Patients With Upper Limb Spasticity
The Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA; Allergan) for the treatment of upper limb spasticity in pediatric patients 2-17 years of age. The approval was based on data from two phase 3 trials: a 12-week study that evaluated the efficacy and safety of Botox in 234 pediatric patients with upper limb spasticity…
Xeomin Approved as First-Line Treatment for Blepharospasm
The FDA has approved Xeomin (incobotulinumtoxinA; Merz) as a first-line treatment for blepharospasm in adults.
FDA to Review Botox for Upper, Lower Limb Pediatric Spasticity
Allergan announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Applications (sBLAs) for Botox (onabotulinumtoxinA) injection for the treatment of patients aged ≥2 years with upper and lower limb spasticity.
