Today, we announced an exciting addition to UCB’s epilepsy pipeline with an agreement to acquire the rights to Proximagen’s Midazolam Nasal Spray (USL261),1 an anti-epilepsy drug (AED) developed as an intended rescue treatment for acute repetitive seizures (ARS, also known as serial, recurrent or cluster seizures) in patients with epilepsy.
USL2612 is a novel investigational midazolam formulation, which has been specifically designed for intranasal delivery without active inhalation. It has been granted orphan drug designation and fast track designation by the United States Food and Drug Administration (FDA), reflecting the significant unmet need which currently exists for ARS rescue treatment.
Acute repetitive seizures impact some of the refractory epilepsy population.3 Patients living with ARS are more likely to experience multiple emergency department visits or hospitalizations in a year and the only U.S. Food and Drug Administration (FDA) approved intervention to date results in a treatment rate of less than 40 percent.
With more than 20 years of leadership in neurological diseases, UCB remains committed to finding solutions for the unmet needs of people living with epilepsy. Our history of research and development of antiepileptic medicines coupled with a deep understanding of the disease, uniquely positions UCB to deliver value for patients living with epilepsy.
Beyond this new addition and our current portfolio of products, our rich pipeline includes early candidates targeting drug-resistant epilepsy and infantile spasm. Our research and development in epilepsy is rooted in science as we invest in finding solutions for patients with unmet needs. And we are continuing to explore new ways to leverage rich data and machine learning to help people living with epilepsy find the right solutions at the right time.
We continue to partner with innovators, payers, and providers where we know that collaboration can help us uncover solutions for patients more efficiently. Our agility helps us leverage science and insights to find solutions that help patients live at their ideal.
Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race, and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.
About UCB in Epilepsy
UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. Our rich epilepsy pipeline is part of our continued investment in finding solutions for patients. At UCB, we are inspired by patients, and driven by science in our commitment to support people with epilepsy.
1 USL261 has not been submitted to or approved by the FDA. These statements solely reflect the opinions of the authors.
3 Haut SR. Current Opinion in Neurology 2015, 28:143–150