Neuraxpharm Receives Positive CHMP Opinion for the Extension of Indication of Epilepsy Treatment Buccolam® to Adults

Extension of indication for Buccolam 10 mg to now include treatment of adults as well as children

Paves way for the extension of well-established and pan-European market-leading brand to include the treatment of adult patients

Barcelona, Spain and Düsseldorf, Germany – 23^rd September, 2024 – Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in respect of extending the therapeutic indication of Buccolam^® (oromucosal midazolam) 10 mg to include the treatment of epilepsy in adults.

Buccolam^® is a prescription brand buccal midazolam indicated for the emergency treatment of epilepsy with prolonged acute convulsive seizures (PACS) and was previously approved across Europe for children. This extension will mean that Buccolam will now be available for the treatment of both children and adults across Europe.

The positive opinion on the extension of the indication to include treatment of adults with 10 mg Buccolam® is based on the results from a population pharmacokinetic (PK) study to support midazolam buccal solution adult posology, based on extrapolation from therapeutic doses in children by matching exposure. The study⁽¹⁾ has shown that the 10 mg dose in adults up to 70 years and with BMI <34 is consistent with the dose that has proven efficacy in elderly children. The 10 mg dose is therefore the optimal, efficacious, and safe dose for Buccolam^® to treat adults with prolonged acute convulsive seizures.

Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, said: “This positive CHMP opinion highlights the significant potential for Buccolam^® as an epilepsy treatment for adult patients, validating our ongoing commitment to this market leading brand. As Europe’s CNS specialist, we focus on meeting the needs of those living with complex CNS conditions by identifying and offering innovative and effective solutions to a greater number of patients and their families across Europe and beyond.”

⁽¹⁾ Lopez Bermudo C, Carreño, M, Valiante C et al. Definition of adult posology of midazolam oromucosal solution for prolonged seizures based on a population pharmacokinetic model. Poster presented EEC 2024. 15th European Epilepsy Congress 2024 Sep 7-11; Rome, Italy.

https://eec2024.conf2go.app/#/app/generalinfo/0a683f4e-d590-48ef-9df9-83d0b01157fe

For further information please contact:

Optimum Strategic Communications

Nick Bastin / Charlotte Hepburne-Scott / Elena Bates

Tel: +44 (0)203 882 9621

Neuraxpharm@optimumcomms.com

About the Neuraxpharm Group

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.

The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.

For more information, please visit https://www.neuraxpharm.com