At Neuraxpharm, we are proud to celebrate the continued success and expansion of Buccolam®, our market-leading buccal midazolam product indicated for the emergency treatment of epilepsy with prolonged acute convulsive seizures (PACS). Since acquiring global rights to the product from Takeda in 2020, Buccolam® has become one of Neuraxpharm’s most strategic and impactful products – demonstrating our commitment to innovation, patient access, and operational excellence.
Key achievements since acquisition
- Global reach expansion
Buccolam® is now commercialized in 25 countries across Europe, as well as Argentina, UAE, Japan and Israel, and is approved in Mexico – broadening access to a life-saving, easy-to-administer treatment for PACS in both children and adults. Considered a standard of care in several EU countries and offered in pre-filled, ready-to-use, non-invasive syringes, Buccolam® is designed for fast, simple administration by caregivers in community settings.
- Indication now expanded to adults
In a significant regulatory milestone, Buccolam® has recently been approved in the EU, UK and Switzerland for use in adults with prolonged acute convulsive seizures (PACS). Having previously been approved across Europe only for children from three months up to 18 years of age, this indication expansion not only reinforces Neuraxpharm’s leadership in emergency seizure care but also adds true value to the European CNS community, opening the door to broader patient access and solidifying Neuraxpharm’s position in key markets.
- Strong commercial growth
Buccolam® has shown remarkable resilience and performance since its loss of exclusivity in 2021. Despite the entry of generics, the brand achieved a ~20% increase in net sales, reinforcing its status as a trusted treatment of choice.
- Optimized manufacturing & supply chain
To ensure future growth and security of supply, we are strategically transferring the production of Buccolam® to our own manufacturing site, Neuraxpharm Pharmaceuticals S.L., in Barcelona. This move enhances operational control, optimizes the production of liquid forms, and offers greater flexibility and reliability across our supply chain.
Looking ahead
Buccolam®’s journey reflects Neuraxpharm’s vision to lead in the CNS space by maximizing the long-term value and availability of medicines, strategic investment, and a patient-first mindset. We remain committed to expanding access and delivering trusted, effective solutions that help reduce hospitalizations and bring peace of mind to people living with epilepsy and their caregivers.