UCB’s Nayzilam nasal spray was approved by US FDA for intermittent, stereotypic episodes of frequent
Nayzilam is a benzodiazepine indicated for the treatment of intermittent, stereotypic episodes of frequent seizure in the patients' age of 12 and more. Patients can take the midazolam without the presence of healthcare professionals. This is the first nasal option available for patients in the United States.
There are around 150,000 people in the USA with uncontrolled epilepsy. This will be helpful for those patients who do not prefer other treatments.
The approval is based on the single study consisting of test dose phase and comparative phase. In the test dose phase, two 5 mg doses were administered and were checked for adverse events. The patients who had no adverse events were considered for comparative phase. 201 patients were considered for comparative phase. Blinded doses of Nayzilam and placebo were administered. If seizures were re-occurred, Nayzilam was administered in both the arms. The primary endpoint is the termination of seizures within 10 minutes and no seizures in the next 6 hours. Termination fo seizures within 10 minutes are 80.6 versus 70.1%. Absence of reoccurrence is 58.2 versus 37.3%.