Bial launches KYNMOBI in the UK for Parkinson’s OFF episodes

Bial has announced the launch of KYNMOBI (apomorphine hydrochloride) in the United Kingdom, introducing the first sublingual film for the intermittent treatment of uncontrolled OFF episodes in adults with Parkinson’s disease whose symptoms are not adequately controlled by oral anti-Parkinson medication.

Around 166,000 people in the UK are estimated to be living with Parkinson’s disease, and many will experience OFF episodes during the course of their illness. These episodes occur when medication, most commonly levodopa, becomes insufficient throughout the day, leading to the return or worsening of motor symptoms such as stiffness, tremor and difficulty moving. OFF periods can have a substantial impact on daily functioning, independence and wellbeing. In this context, rescue treatments used alongside regular medication are considered important for the rapid, on-demand relief of symptoms.

KYNMOBI is delivered as a sublingual film placed under the tongue and held in position until it dissolves completely. This method of administration avoids the first-pass effect associated with oral therapies and supports a rapid onset of action. The availability of a sublingual formulation represents a new way of delivering a well-established treatment option for people experiencing intermittent OFF episodes.

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The efficacy and safety of sublingual apomorphine have been demonstrated in two Phase III clinical studies. In a double-blind, placebo-controlled trial, treatment resulted in a statistically significant improvement in motor function, measured by the MDS-UPDRS Part III score at 12 weeks, compared with placebo. A higher proportion of patients also achieved a subject-rated full ON response within 30 minutes of dosing. In a second open-label, randomised crossover study, sublingual apomorphine showed therapeutic efficacy comparable to subcutaneous apomorphine, with numerically similar improvements in motor scores following treatment.

“I am delighted to see Kynmobi becoming available as another therapeutic option in the UK for Parkinson’s disease. It is by having a breadth of therapies to select from that we, as clinicians, are able to provide care personalised to the requirements and preferences of patients. It is particularly pleasing to see a new formulation coming through to market based on trials that UK sites helped to deliver. By actively engaging with research opportunities and supporting trial delivery we can all ensure that people with Parkinson’s continue to benefit from innovative therapies.”

Camille Carroll, Consultant Neurologist and Professor of Clinical Neuroscience at the Translational and Clinical Research Institute at Newcastle and Faculty of Health, University of Plymouth

Across pooled Phase II and Phase III studies, the most commonly reported adverse reactions included nausea, somnolence and dizziness. Oropharyngeal adverse events such as swelling, irritation and ulceration were also commonly observed in patients treated with sublingual apomorphine.

Bial stated that the UK launch follows a decentralised European approval process and reflects the company’s ongoing commitment to people living with Parkinson’s disease and to strengthening its position in neurology across Europe.

This news item has been summarised using AI and checked by humans before publication.


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Sources
Bial press release

Kynmobi (apomorphine hydrochoride) – Summary of Product Characteristics – available on www.medicines.org.uk (last accessed: December 2025)

Parkinson’s UK – Parkinson’s statistics; available on www.parkinsons.org.uk/about-us/parkinsons-statistics (last accessed: December 2025)