Merz Therapeutics Receives TGA Approval for XEOMIN® in Australia

23 November 2023 | Thursday | News

Merz Therapeutics, a business of the Merz Group and leader in the field of neurotoxins, has received approval from the Therapeutic Goods Administration (TGA) in Australia for the use of XEOMIN® for the treatment of chronic sialorrhea in adults and children
Image Source : Public Domain

Image Source : Public Domain

This marks a significant milestone as XEOMIN® is the first approved neurotoxin for the treatment of this condition in the Australian market. Additionally, XEOMIN ® is now approved for the treatment of pediatric spasticity of the upper and lower limb in children.

A new era in sialorrhea treatment

Sialorrhea, also known as drooling, is one of the most common chronic conditions that can occur as a result of neurological damage to the brain and is one of the most common chronic conditions in stroke survivors and children living with chronic neurological conditions like cerebral palsy. People living with sialorrhea cannot control their saliva and may produce excess amounts. The consequences range from quality-of-life issues, such as social isolation and unintelligible speech, to facial skin maceration and even increased morbidity due to choking, aspiration, dehydration and an increased risk of pneumonia.

Until recently, only oral medications were approved for the treatment of sialorrhea, and these were associated with a number of systemic side effects. “We are proud to contribute to the improvement of treatment options available to people living with sialorrhea. With the new approvals we can address a dire medical need and deliver better outcomes for more patients,” explains Stefan König, Chief Executive Officer Merz Therapeutics. “Moving forward, we will focus on spreading awareness of the new treatment option among healthcare professionals, train them in the proper injection of XEOMIN® and thus empower them to include it in their practice”. Andrea von der Lippe, Head of Region International Markets, adds: “We are excited to extend our portfolio of treatment options in Australia and hope to build on this success in other markets in the APAC region.”

Enabling comprehensive treatment for children living with spasticity

“A full-label approval for both lower and upper limb spasticity is a fantastic achievement in itself and we are especially proud that this was based on our own clinical study data with XEOMIN®,” says Stefan Albrecht, Chief Scientific and Medical Officer. “This will enable healthcare professionals to treat children living with multiple patterns of spasticity more comprehensively.”

Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (‘muscle tone’) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.1 Spasticity is a chronic condition being a part of so-called upper motor neuron (UMN) syndrome, which is also characterized by muscle spasms, increased deep tendon reflexes, as well as loss of muscle strength, dexterity and endurance. In children and adolescents, the most common cause of UMN syndrome is cerebral palsy (CP), whose incidence in developed countries is 0.20-0.35% neonates. Approximately 80-90% of CP patients suffer from spasticity. Children and adolescents living with spasticity require treatment and rehabilitation throughout their lives. The degree of disability may however differ among individuals, depending on symptoms intensity, number of involved body parts, and concomitant disorders.

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