FDA Approves Myobloc, Injection Treatment for Chronic Drooling

Myobloc approved

Myobloc (rimabotulinumtoxinB) injections are approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic sialorrhea, or drooling, a condition often experienced by Parkinson’s patients.

Myobloc, marketed by US WorldMeds, is the first botulinum toxin type B approved for use in sialorrhea. Injections are given by healthcare professionals directly into two of the major glands producing saliva, the parotid and submandibular glands

According to US WorldMeds, a single dose can significantly reduce drooling within one week of treatment and and remain effective for up to three months.

Sialorrhea, or drooling, refers to saliva in such excess that it spills from the mouth. This is a common and bothersome symptom of neurological disorders like amyotrophic lateral sclerosis (ALS), cerebral palsy, and stroke, and it affects up to 75% of all Parkinson’s patients.

“Sialorrhea can be highly distressing for patients and their caregivers and can have a significant, negative impact on quality of life. If left untreated, pooling of saliva can lead to irritation of the skin around the mouth, oral hygiene complications, speech difficulties, and sleep interruption,” Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorder Center of Boca Raton Regional Hospital, said in a news release.

“These impacts can leave patients with compromised physical wellbeing, as well as feeling embarrassed by their condition, causing a lack of confidence and isolation,” Isaacson added.

Myobloc works by blocking the transmission of certain nerve signals to muscles and salivary glands. Specifically, it inhibits the release of the neurotransmitter acetylcholine, a chemical substance involved in the activation of the sweat and salivary glands.

Myobloc has already been approved, as intramuscular injections, to treat the abnormal head position and neck pain that occurs in adults with cervical dystonia.

Its approval for chronic sialorrhea came under a supplemental Biologics License Application (sBLA) that was supported by clinical trials, including a multicenter Phase 3 efficacy and safety study (NCT01994109) in 54 Parkinson’s patients with sialorrhea.

The trial met its primary efficacy goals.  There was a significant reduction in saliva production and attenuation of symptoms, in a dose-dependent manner, four weeks after a single Myobloc’s injection compared to placebo.

An open-label phase of the study also demonstrated safety and effectiveness over time, with the injection treatment given for about one year. Some adverse events, specifically gastrointestinal ones, were more common in patients using Myobloc than placebo (31% vs. 7%). The most frequent side effect reported was dry mouth.

No serious adverse events were attributed to the medicine, and no patients discontinued its use due to treatment side effects.

“We are committed to helping patients who struggle with confidence due to their sialorrhea. This new indication for Myobloc offers a fast-acting and proven treatment,” said P. Breckinridge Jones, CEO of US WorldMeds.

“We are proud to support health care providers with an option that can have such a positive impact on the lives of patients and their caregivers,” he added.

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FDA Approves Xeomin to Treat Excessive Drooling, Common in Parkinson’s Patients

Xeomin FDA approval

Xeomin (incobotulinumtoxinA) has been approved by the U.S. Food and Drug Administration to treat adults with chronic sialorrhea, or excessive drooling, a condition often experienced by Parkinson’s disease patients.

Merz Neurosciences, a division of Merz North America, announced that its supplemental biologics license application for Xeomin was granted FDA approval to treat adults with sialorrhea, making it the only approved neurotoxin for this indication in the U.S.

Approval came under priority review by the FDA, a status given to therapies with the potential to significantly improve the safety or effectiveness of treatment, diagnosis, or prevention of serious conditions.

“Until now, there has not been an FDA approved treatment for this debilitating condition,” Kevin O’Brien, vice president and U.S. head of neurosciences at Merz North America, said in a press release. “This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders.”

Excessive drooling occurs in 50-80 percent of Parkinson’s patients, especially in men, and can lead to consequences such as social isolation and embarrassment. Patients with other neurological conditions, such as cerebral palsy or those who have had a stroke, may also have this disorder, which is most commonly caused by poor oral and facial muscle control. Excessive production of saliva and postural problems are other possible causes.

Xeomin is injected directly into muscles and glands, and can block nerve cell signals that cause altered muscular responses.

Its approval was based on results from the randomized, double-blind, placebo-controlled Phase 3 SIAXI clinical trial (NCT02091739).

The study assessed the effectiveness and safety of two different doses of Xeomin, compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic sialorrhea.

A total of 184 adults with excessive drooling associated with parkinsonism, stroke, or traumatic brain injury received either 75 Units (U) or 100 U of Xeomin, or a placebo.

Compared with pre-treatment assessments and with placebo, 100 U of Xeomin significantly reduced the unstimulated salivary flow rate (uSFR) and the severity and frequency of excessive drooling — as assessed by the Global Impression of Change Scale (GICS), routinely used in studies of neurological disorders — at four weeks.

The frequency of adverse events was similar between placebo and Xeomin at both doses, and no new or unexpected adverse events were reported.

Merz had already reported that both doses improved uSFR and GICS at weeks eight, 12, and 16 of treatment. Other analyses, including the Drooling Severity and Frequency Scale, confirmed the effectiveness of both treatment regimens.

Xeomin was previously approved to treat adults with abnormal head position and neck pain due to involuntary contraction of neck muscles, abnormal spasm of the eyelids (blepharospasm) in patients who were previously treated with Botox (onabotulinumtoxinA), and to reduce upper limb spasticity, or muscle stiffness.

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Source: Parkinson's News Today