• Effective and well tolerated in SeLECTS
• Well-established treatment in Europe
• Now licensed in the UK
• Oral liquid is paediatric-focussed formulation
The first licensed formulation of sulthiame in the UK, is now available from Desitin Pharma UK. Ospolot® 20mg/ml oral suspension (sulthiame) is indicated for the treatment of Self-Limited Epilepsy with Centrotemporal Spikes (SeLECTS) (please refer to SmPC for details).
Studies have shown that sulthiame reduces seizure frequency in SeLECTS. 91% of patients treated with sulthiame remained seizure free for 24 weeks, [Borggraefe et al, 2013].
Sulthiame has demonstrated benefits compared to other ASMs (anti-seizure medications) in the treatment of SeLECTS. When compared to levetiracetam, sulthiame has a significantly lower withdrawal rate from treatment due to recurrence of seizure or adverse effects, but still shows the same efficacy rate [Borggraefe et al, 2013].
Sulthiame tablets have been used for many years in the UK on a “named patient” basis or through importation of an unlicensed medicine from Germany, and was listed by NICE in 2022 for the treatment of SeLECTS, even though it was not licensed at the time of publication, [NICE, 2022]. However, there is considerable clinical use behind this new product. Sulthiame has been licensed for over 40 years in many European countries and is prescribed first line in Germany, Switzerland and Austria for SeLECTS. There have been 680,000 patient months of sulthiame prescribed in Germany alone in the last 3 years [IQVIA Data].
SeLECTS is one of the most common childhood epilepsies. The median age of onset is 7 years and the incidence is approximately 6 per 100,000, [Borggraefe, 2024].
Although SeLECTS generally has a good prognosis and resolves during adolescence, some studies show that it is linked to neuropsychological impairment [Garcia 2015, Kirby 2017; Wickens 2017] and could potentially progress to more serious forms of epilepsy.
For more information contact: Desitin at enquiries@desitin.co.uk
Desitin Pharma is a European pharmaceutical company with a 100 year history of research and development for the innovative management of neurological disorders, particularly in the fields of epilepsy and Parkinson’s syndrome.
Prescribing Information
For the Ospolot 20mg/ml Oral Suspension Prescribing Information please scan the QR code, or use the following link https://desitin.co.uk/pi/8KRY
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Desitin Pharma Limited on Medinfo@desitin.co.uk.
References
Borggraefe. (2024). Self limited focal epilepsies of childhood syndromes and overview Sulthiame. Clin Epileptol. 37:3-8
Borggraefe, I., Bonfert, M., Bast, T., Neubauer, B. A., Schotten, K. J., Maßmann, K., Noachtar, S., Tuxhorn, I., May, T. W., & Heinen, F. (2013). Levetiracetam vs. sulthiame in benign epilepsy with centrotemporal spikes in childhood: A double-blinded, randomized, controlled trial (German HEAD Study). European Journal of Paediatric Neurology, 17(5), 507–514. https://doi.org/10.1016/j.ejpn.2013.03.014
Garcia-Ramos, C, et al. (2015). Cognition and Brain Development in Children with Benign Epilepsy with Centrotemporal Spikes. Epilepsia, 56(10), 1615–1622. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4593750/
IQVIA Medical Research data
Kirby, A.t al. (2017). Benign Childhood Epilepsy with Centrotemporal Spikes (BECTS) and Developmental Co-ordination Disorder. Epilepsy Behav., 72, 122–126. https://pubmed.ncbi.nlm.nih.gov/28575760/
NICE Epilepsies in children, young people and adults NICE guideline [NG217] Published: 27 April 2022, NICE (2022). https://www.nice.org.uk/guidance/ng217
Ospolot 20mg/ml Oral Suspension SmPC, (2024).
Wickens, S. , B. S. C. , and D. W. (2017). Cognitive Functioning in Children with Self-Limited Epilepsy with Centrotemporal Spikes: A Systematic Review and Meta-Analysis. Epilepsia, 58(10), 1673–1685.
