Posted from: Friday, October 04, 2019 - 02:44 PM - Present

Myobloc Receives New Indication

August 20, 2019 – The U.S. FDA has approved a new indication for Myobloc® (rimabotulinumtoxinB), manufactured by US WorldMeds, to treat chronic sialorrhea (excessive drooling) in adults.

Chronic sialorrhea is a common symptom experienced by patients with neurological disorders such as Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS), cerebral palsy, and stroke. The effects of chronic sialorrhea include skin irritation, oral health complications, speech difficulties, interrupted sleep, chocking, and aspiration pneumonia. It can also lead to social isolation and emotional distress due to a stigmatized view of the condition.

In clinical trials, Myobloc decreased salivary production and improved symptoms compared to placebo. Improvements were observed as early as one week after treatment, and lasted for up to three months. Recommended dosing under the new indication 1,500 to 3,500 units total, divided between the parotid glands and submandibular glands, no more than once every 12 weeks. Myobloc is the only botulinum toxin currently on the U.S. market that does not require reconstitution prior to administration. Like all botulinum toxin products, it must be administered by a qualified healthcare professional, and carries a black box warning that its effects may spread from the area of injection hours to weeks after administration. This can lead to potentially life-threatening difficulties with breathing and swallowing.

Myobloc is also approved to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults.

Last Updated Friday, October 18, 2019 - 12:30 AM.