September 30, 2018 / BIOON /-Biopharma, a specialist pharmaceutical company based in San Diego, USA, focuses on licensing, developing, and commercializing drugs for epilepsy and other central nervous system (CNS) diseases. Recently, the company announced that it has submitted a new drug application (NDA) of Valtoco (Diazepam Nasal Spray) to the US Food and Drug Administration (FDA) for clustered or acute recurrent episodes of epilepsy in patients 6 years and older the treatment.

Valtoco is a lead drug candidate from Neurelis, a patented formula of diazepam (diazepam) that combines a unique combination of a vitamin E-based solution and Intravail (visceral) absorption enhancement. Earlier, the FDA had granted Valtoco orphan status and fast-track status.

It is estimated that there are approximately 3.4 million epilepsy patients in the United States, and approximately 200,000 new cases are diagnosed each year. Despite long-term daily oral medications, a significant number of patients continue to experience seizures. About 170,000 of these uncontrolled patients are at risk of clustering or acute recurrent episodes.

Valtoco's NDA is supported by data from a wide range of clinical and preclinical studies, including studies in healthy volunteers and patients with epilepsy. In patient studies, more than 1,600 seizures have been treated with Valtoco. In the study, Valtoco showed high bioavailability, low variation between each dose, and well tolerated.

Craig Chambliss, president and CEO of Neurelis, said clustered or acute recurrent seizures are dangerous and devastating in the lives of patients with epilepsy, and Valtoco will provide a safe, reliable, well-tolerated, simple Ready-to-use nasal spray.