The first sublingual therapy for the intermittent treatment of uncontrolled OFF episodes for adult people living with Parkinson’s Disease
LONDON--(BUSINESS WIRE)--Bial, an innovation-driven biopharmaceutical company, today announced the launch of KYNMOBI® (apomorphine hydrochloride) in the United Kingdom, the first sublingual film indicated for the intermittent treatment of OFF episodes in adult patients with Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication1.
In the United Kingdom, it is estimated that around 166,000 people suffer from Parkinson's disease,2 most of which may experience OFF periods at some point. These episodes occur when the medication, usually levodopa, becomes insufficient throughout the day, leading to the reappearance of motor symptoms such as stiffness, tremors, and difficulty moving, impacting daily activities and affecting their autonomy as well as their well-being3. In this context, rescue treatments, as a complement to regular antiparkinsonian medication, are essential. These types of on-demand therapies act quickly and specifically to relieve these symptoms and improve the quality of life for patients4.
Tom Foltynie, Consultant Neurologist and Professor of Neurology at the National Hospital for Neurology & Neurosurgery, Queen Square, London, said: “Motor fluctuations are a major concern for patients as Parkinson’s progresses. Oral doses of Levodopa can take an hour before they start to take effect, and some doses fail completely because of slow stomach emptying or competition for absorption from dietary protein. Identifying other mechanisms of administration for dopaminergic therapies is therefore of major importance and we look forward to assessing the benefits of sublingual apomorphine in our PD patients experiencing this problem.”
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 said: “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.”
The availability of a sublingual formulation of apomorphine represents a significant advancement in the delivery of a well-established treatment for Parkinson’s disease. Thanks to this route of administration, the well-known first-pass effect is avoided, thus achieving a rapid onset of action and supporting patients experiencing intermittent OFF episodes. The sublingual film is placed under the tongue and kept in that position until it completely dissolves.
The efficacy and safety of sublingual apomorphine in the intermittent treatment of “OFF” episodes in adult patients with Parkinson's disease (PD) has been demonstrated in two Phase III studies, one double-blind, placebo-controlled (Study 1) and one open-label, randomised, crossover, active-comparator (subcutaneous apomorphine) trial utilising a single-blinded rater (study 2). These studies were similar in design in that each had a titration phase in which subjects were titrated to an effective and tolerable dose.1
In Study 1, treatment with sublingual apomorphine resulted in a statistically significant mean improvement in MDS-UPDRS Part III score at Week 12 compared with placebo (primary endpoint; LS mean difference –7.6; P=0.0002; N=109), and a higher proportion of patients achieving a subject-rated full ON response within 30 minutes of dosing (key secondary endpoint, P=0.0426) compared with placebo.1
In Study 2, sublingual apomorphine demonstrated therapeutic efficacy comparable to subcutaneous apomorphine (N=74). After four weeks of treatment in each crossover period, the LS mean change in MDS-UPDRS Part III scores from pre-dose to 90 minutes post-dose (primary endpoint) was –13.55 (95% CI: –16.39, –10.70) for sublingual apomorphine and –13.78 (95% CI: –16.65, –10.90) for subcutaneous apomorphine, indicating numerically similar improvements with both formulations.1
The most common adverse reactions reported in pooled analyses for two phase II and two phase III clinical studies were nausea (20.5%) during titration phase, and nausea (22.0%), somnolence (8.5%) and dizziness (5.9%) during maintenance phase. Oropharyngeal adverse events (swelling, oedema, pain, irritation, ulceration) were also commonly observed in the patients treated with sublingual apomorphine.1
“At Bial, our commitment to people living with Parkinson’s is unwavering. OFF episodes can affect daily life significantly, turning everyday moments into real challenges. We are delighted to offer a treatment option that helps patients and healthcare professionals manage symptoms as difficult and disabling as OFF episodes can be. Bringing this medicine to UK patients - the fifth country to do so - highlights Bial’s ongoing dedication to Parkinson's patients and marks an important step in the company's ambition, aiming to be a reference and a top partner in neurology and Parkinson’s Disease in Europe," says Magarete Ruiz, Country Manager of Bial in United Kingdom.
The commercialisation of KYNMOBI® (apomorphine hydrochloride) sublingual film in the United Kingdom follows a decentralised approval process in Europe. Following an agreement with Sumitomo Pharma America, Inc. (SMPA), Bial received exclusive commercial license rights to commercialise apomorphine hydrochloride sublingual film in the European Union, the European Economic Area, and the United Kingdom.
About Parkinson’s Disease and OFF Episodes
Parkinson’s disease affects everyone differently, and most experience ON and OFF episodes. ONs are the periods during which the patient responds to medication and experiences satisfactory improvement in motor and non-motor symptoms. OFF episodes occur when the patient experiences changes in their clinical state, i.e. motor and/or non-motor symptoms may reappear or worsen5,6. OFF episodes can manifest as Parkinsonism with tremor, rigidity, bradykinesia, gait impairment, and falling, in addition to non-motor symptoms7. Within 2-5 years, up to 50% of patients may experience some degree of motor complications, and between 80% to 100% of Parkinson’s disease patients will develop motor complications after 10 years of dopaminergic therapy8.
About Bial
BIAL is an innovation-driven pharmaceutical company dedicated to improving the health and lives of people worldwide. With a strong commitment to therapeutic innovation, BIAL has established an ambitious R&D programme, consistently investing over 20% of its annual revenue in this area. The company focuses on two key areas with high unmet medical needs: neurosciences and rare diseases. In Europe, BIAL operates manufacturing facilities and an R&D centre at its headquarters in Portugal, and maintains subsidiaries in Spain, Germany, the United Kingdom, Italy, and Switzerland. In addition, BIAL is present in the United States and selected emerging markets. As part of its international growth strategy, the company collaborates with established partners through strategic alliances and licensing agreements to expand access to its healthcare solutions. Today, BIAL’s products are available in more than 50 countries, advancing its mission to deliver transformative medicines that empower patients’ lives.
About Bial Pharma UK Ltd
Founded in 2010, Bial Pharma Ltd is the British subsidiary of Bial, committed to providing patients and the scientific community with innovative therapeutic options. Based in Windsor, Berkshire, Bial Pharma UK Ltd markets medicinal specialities for Parkinson’s disease and Epilepsy. The company actively supports clinical trials and independent research studies in the United Kingdom, contributing to the advancement of scientific knowledge and patient care.
References
- 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)
- Olanow, C. W., Poewe, W., Rascol, O., & Stocchi, F. (2021). On‐Demand Therapy for OFF Episodes in Parkinson’s Disease. Movement Disorders, 36(10), 2244-2253. https://doi.org/10.1002/mds.28726
- Hauser, R. A., LeWitt, P. A., & Comella, C. L. (2021). On demand therapy for Parkinson’s disease patients: Opportunities and choices. Postgraduate Medicine, 133(7), 721-727. https://doi.org/10.1080/00325481.2021.1936087
- Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease (2009). Neurology. 2009;72(21 Suppl 4):S1-136.
- Chou KL, Stacy M, Simuni T, et al. The spectrum of “off” in Parkinson’s disease: what have we learned over 40 years? Parkinsonism Relat Disord. 2018;51:9-16.
- Olanow CW, Factor SA, Espay AJ, Hauser RA, Shill HA, Isaacson S, Pahwa R, Leinonen M, Bhargava P, Sciarappa K, Navia B, Blum D; CTH-300 Study investigators. Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study. Lancet Neurol. 2020 Feb;19(2):135-144. doi: 10.1016/S1474-4422(19)30396-5. Epub 2019 Dec 7. PMID: 31818699
- Freitas ME, Hess CW, Fox SH. Motor Complications of Dopaminergic Medications in Parkinson's Disease. Semin Neurol. 2017 Apr;37(2):147-157. doi: 10.1055/s-0037-1602423. Epub 2017 May 16. PMID: 28511255; PMCID: PMC5990008.
Contacts
Media:
Bial
Susana Vasconcelos
Director, Communication
T. +351229866100 | E. susana.vasconcelos@bial.com
