Upsher-Smith Laboratories Adds ITI-111 (Nasal Midazolam) to CNS Development Pipeline
MAPLE GROVE, Minn., June 28 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced an agreement with Ikano Therapeutics, Inc. to obtain exclusive global rights to ITI-111, Ikano's nasal midazolam. Under terms of the agreement, Upsher-Smith will assume all further development, testing and clinical study of nasal midazolam as an orphan drug for the management of acute repetitive seizure (ARS) in patients with epilepsy. Upon successful completion of development and regulatory approval, Upsher-Smith will commercialize the product, initially in the U.S. market.
"Currently, epilepsy patients experiencing cluster seizures or acute repetitive seizures have limited options for treatment," said Dr. Jacqueline French, Professor of Neurology at the New York University Comprehensive Epilepsy Center. "A product such as nasal midazolam could represent an additional treatment option for these patients, and has the potential to address a significant unmet need."
Some patients with epilepsy periodically experience episodes of ARS that are distinct from their usual seizure pattern. There have been no new FDA-approved products targeting ARS in nearly 15 years.(1)
"The addition of nasal midazolam to our growing development portfolio represents a significant milestone in helping us achieve our vision of building a leadership position in the central nervous system field," said Mark Evenstad, President of Upsher-Smith. "We will continue to focus our efforts on the development of products that address significant unmet needs for patients with epilepsy, Parkinson's disease and Alzheimer's disease."
Upsher-Smith's development programs for the management of epile