Drug from Raleigh-based Merz receives FDA approval to treat chronic drooling

The U.S. Food and Drug Administration approved Merz’s supplemental Biologics License Application for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling.

“Pediatric patients living with chronic sialorrhea have suffered with this debilitating condition without a viable long-acting treatment option,” said Kevin O’Brien, president of North America, Merz Therapeutics. “Merz Therapeutics is proud to offer Xeomin, the first and only FDA-approved neurotoxin treatment that is uniquely purified to provide safe and effective treatment for this condition. This approval reinforces our ongoing commitment to advancing new indications for Xeomin to meet the needs of adult and pediatric patients living with movement disorders.”

The FDA approval was based on a successful Phase 3 multi-center study evaluating the safety and efficacy of Xeomin in 255 children and adolescents aged 2 – 17 years.

Xeomin demonstrated significantly reduced unstimulated salivary flow rate and functional improvement in drooling versus placebo among patients aged 6 ‒ 17 years after four weeks, and sustained efficacy over 64 weeks. Patients aged 2 to 5 also showed comparably improved function.

No patients demonstrated clinical resistance or secondary treatment failure due to neutralizing antibodies, supporting the importance of Merz’s unique purification process for Xeomin, according to the company. The safety findings were similar to previous adult and pediatric studies and in line with the known safety profile of Xeomin.

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“It’s estimated that 300,000 children in the U.S. suffer from chronic drooling due to cerebral palsy or brain injury, but this approval provides them a safe and efficacious treatment option that they can use long-term with low probability they’ll build up an immunity to it with repeated use,” said Elizabeth Moberg-Wolff, M.D., of Pediatric Rehabilitation Medicine Associates and a paid spokesperson for Merz. “Having Xeomin approved to treat another symptom that children living with movement disorders experience is an important milestone for patients, caregivers and healthcare providers.”

Sialorrhea is a commonly occurring condition in neurologically impaired children who have cerebral palsy or have suffered a traumatic brain injury. The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and problems controlling facial muscles.

Sialorrhea can cause a variety of physical and psychosocial complications, including dehydration, odor and social stigmatization.

Versatile therapy

Xeomin, or incobotulinumtoxinA, has become a versatile product for Merz. With the latest FDA action, it is now approved for six first-line, or primary, indications in the United States and has helped more than 3.6 million patients worldwide, according to the company.

Xeomin was first approved by the FDA in 2010 for treating blepharospasm, or involuntary blinking, and cervical dystonia, an involuntary contraction of neck muscles. In 2015 it was approved for treating upper limb spasticity, and in 2018 it was approved for treating chronic sialorrhea. All of these indications were for adults.

Earlier this year Xeomin was approved for treating upper limb spasticity in children, the therapy’s first pediatric indication.

Xeomin is also widely used as a cosmetic treatment for easing frown lines between the eyebrows. It has been approved for that use since 2011 and competes with Botox, a similar botulinum toxin.

The active ingredient in Xeomin is botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum. Xeomin acts on nerve endings in muscles to prevent muscle fibers from contracting.

Merz Therapeutics, with North American headquarters in Raleigh, is a business of Merz Pharmaceuticals, a global healthcare company owned by the Merz Group, a privately held, family-owned company based in Frankfurt, Germany.

(C) N.C. Biotech Center

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