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Aculys Pharma Announces Positive Phase 3 Interim Analysis Results for Diazepam Nasal Spray in the Treatment of Epileptic Seizures

Aculys Pharma, a clinical-stage biopharmaceutical company specializing in innovative treatments for neurological conditions, has reported a significant achievement in its Phase 3 clinical study of a diazepam nasal spray, offering new hope for patients suffering from epileptic seizures. The promising results were obtained from Japan’s first domestic Phase 3 clinical trial for patients aged 6 to 17.

The primary objective of this study was to evaluate the effectiveness and safety of diazepam nasal spray (referred to as NRL-1) in treating status epilepticus and epileptic seizures that may lead to status epilepticus, specifically targeting the Japanese patient population.

The interim analysis of this groundbreaking trial has yielded positive results. The primary efficacy endpoint, which involved the proportion of patients achieving resolution of clinically relevant seizures within 10 minutes after a single dose and remaining free from seizures for 30 minutes, was met. Moreover, the study revealed that the drug is not only effective but also safe and well-tolerated. No adverse events related to respiratory depression, which could be attributed to the drug, were observed.

Based on the compelling data obtained from this interim analysis, Aculys Pharma is now preparing to submit a New Drug Application for diazepam nasal spray. If approved, this will mark a significant milestone as the first intranasally administered antiepileptic drug in Japan, addressing the urgent treatment needs of patients with recurrent epileptic seizures.

Kazunari Tsunaba, President and Representative Director of Aculys Pharma, emphasized the importance of this development, stating, “We believe that access to emergency treatment that is convenient and easy for non-medical personnel to use appropriately in the event of a seizure, in addition to being effective and safe, will help reduce the emotional burden on patients and their caregivers, as well as the risk of sequelae due to prolonged seizures.”

Diazepam has been a staple in Japanese medical practice for over six decades, primarily administered through injections and other forms. Diazepam nasal spray, developed by Neurelis, Inc. in the United States, received an exclusive license for development and commercialization by Aculys Pharma in Japan and the Asia-Pacific region. In 2020, the FDA approved Neurelis’ VALTOCO® (diazepam nasal spray) for the acute treatment of frequent seizure activity in epilepsy patients, aged six and older.

Aculys Pharma’s mission extends beyond developing innovative drugs; the company is also actively working with external partners to identify and address issues faced by individuals with epilepsy in Japan. This collective effort aims to improve the healthcare delivery system for epilepsy patients and create a comprehensive ecosystem to support those dealing with epileptic seizures.

As Aculys Pharma continues to use the latest digital technologies to tackle medical challenges from a societal perspective, they remain committed to delivering new means of medical care and hope to patients with recurrent seizures and their caregivers.

Epilepsy is a complex neurological condition affecting millions of people globally, and Aculys Pharma is dedicated to contributing to its management and treatment through scientific advancements.


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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