The first sublingual therapy for the on-demand treatment of OFF episodes in Parkinson’s disease
BIAL, a hundred-year-old innovation-driven biopharmaceutical company, today announced the launch of KYNMOBI® (apomorphine hydrochloride), the first and only sublingual therapy marketed in Portugal and Spain, for the on-demand treatment of OFF episodes in adult patients with Parkinson’s disease who are not sufficiently controlled by oral anti-Parkinson medication1,2.
In Portugal, it is estimated that Parkinson's Disease may affect around 20,000 people3 and in Spain 160,0004, and all of them will experience OFF periods at some point. These episodes occur when medication becomes insufficient throughout the day, leading to the reappearance of symptoms, which can be motor (such as stiffness, tremors, and difficulty in getting around) or non-motor, impacting daily activities and affecting their autonomy as well as their well-being. In this context, on-demand 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 patients 5,6.
António Portela, BIAL’s CEO, emphasises that “BIAL has an ongoing commitment to Parkinson's patients. The launch of KYNMOBI® in Portugal and Spain reflects this commitment and is an important step in our development and expansion strategy in Europe, where we aim to be the leading company in the field of Parkinson's Disease. We are delighted to be able to make this treatment option available and potentially contribute to helping these patients cope with symptoms as difficult and disabling as OFF episodes can be in their daily lives.”
Following an agreement with the pharmaceutical company Sumitomo Pharma America, Inc. (SMPA), BIAL received the exclusive commercial licence rights for the apomorphine hydrochloride sublingual film in the European Union, the European Economic Area, and the United Kingdom. The commercialisation of KYNMOBI® followed a decentralised approval process in Europe. In addition to Portugal and Spain, KYNMOBI® has also been marketed in Germany since May 2024 and is expected to be launched in Italy this year.
Around 10 million people worldwide live with Parkinson's disease. It is the fastest-growing neurological disease and its prevalence is expected to double by 20507.
BIAL is committed to expanding treatment options for people with Parkinson’s disease in Europe and helping patients cope with the difficult and disabling symptoms of OFF episodes.
About Parkinson’s Disease and OFF Episodes
Parkinson's disease is the second most common neurodegenerative disease, affecting patients differently, with the majority experiencing 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 worsen8,9.
OFF episodes can manifest as parkinsonism with tremor, rigidity, bradykinesia, gait impairment, and falling, in addition to non-motor symptoms10. 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 therapy11. Treatments for Parkinson’s disease predominantly focus on controlling the motor symptoms of the disease to reduce tremors, stiffness, and slowness12.
About BIAL
BIAL is a hundred-year-old innovation-driven biopharmaceutical company aiming to improve people’s lives worldwide.
Being a fully integrated company strongly committed to therapeutic innovation, BIAL has established an ambitious R&D program, consistently investing more than 20% of its annual revenue in this field. Key focus areas for the company are neurosciences and rare diseases.
In Europe, BIAL has a production site and R&D unit in Portugal (headquarters) and affiliates in several countries - Spain, Germany, the United Kingdom, Italy, and Switzerland. Additionally, BIAL is present in the US and some emerging markets.
The company’s internationalization strategy also sought the establishment of partnerships and license agreements, thus collaborating with well-established partners to bring its health solutions to everyone in need. BIAL products are present in fifty countries, fulfilling its purpose of making a real difference in the lives of people living with severe diseases across the world.
For more information about BIAL, please visit: www.bial.com.
References
- Kynmobi® 10 mg, 15 mg, 20 mg, 25 mg e 30 mg película sublingual – Folheto Informativo. Lisboa: INFARMED; 2024. Disponível em: https://extranet.infarmed.pt/INFOMED-fo/
- Kassubek J, et al. Long-term safety, tolerability and efficacy of apomorphine sublingual film in patients with Parkinson’s disease complicated by OFF episodes: a phase 3, open-label study. J Neurol. 2024;271(6):3554-3570.
- Sociedade Portuguesa de Doenças do Movimento. Disponível em: https://spdmov.org/doenca-de-parkinson-vai-aumentar-em-portugal/
- Sociedad Española de Neurología. (s.f.). La enfermedad de Parkinson en España. Disponible en: https://www.sen.es/saladeprensa/pdf/Link439.pdf
- 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
- Parkinson’s Europe. Website: Parkinson’s Statistics - Parkinson's Europe. Acesso em março 2025.
- Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease (2009). 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.
- KYNMOBI for the treatment of OFF episodes in Parkinson’s Disease, USA. 16 September 2022. Clin Trials Arena. Available at: https://www.clinicaltrialsarena.com/projects/kynmobi-for-the-treatment-of-off-episodes-in-parkinsons-disease/ (Accessed Feb. 2024).
