Tokyo, Japan, June 24, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced that it has received marketing approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan for “Spydia® Nasal Spray 5 mg, 7.5 mg, and 10 mg” (generic name: diazepam) for the treatment of status epilepticus or seizures with potential progression to status epilepticus. Spydia® is the first intranasal anti-seizure medication approved in Japan, and notably the first immediate-use seizure medication* for adults approved for out-of-hospital use. Current treatment options have unmet needs concerning time to administration, patient accessibility, and emergency transport. Spydia® is expected to address these challenges.
“We are delighted to have received manufacturing and marketing approval for Spydia®, the first product we’ve developed at Aculys,” said Hidemasa Tanigaki, Chief Executive Officer of Aculys Pharma. “We are hugely grateful to all our stakeholders who have supported us along the way to this milestone and sincerely hope that this new treatment option will provide meaningful support for patients and caregivers affected by the unpredictability of epileptic seizures.”
* Immediate-use seizure medication: a treatment administered by a caregiver or designated person in emergency situations to stop an ongoing seizure
The approval is based on results of a multi-center Phase 3 clinical study in Japan, a Phase 1 clinical study in Japan, and a clinical study outside of Japan.
[Related news]
Aculys Pharma Delivers Positive Phase 3 Clinical Study Interim Analysis Result of a Diazepam Nasal Spray: An Antiepileptic Drug for the Treatment of Epileptic Seizures (Aculys Pharma, October 18, 2023).
https://aculys.com/en/20231018/
As a Japan-based biopharmaceutical startup committed to solving social issues related to neuropsychiatric diseases and addressing drug lag/loss, Aculys Pharma is working to ensure that this treatment becomes available to all patients in need as quickly as possible.
■About Diazepam and Spydia®
Diazepam has been used for approximately 60 years in Japan, primarily in injectable form, for seizure treatment. Rectal diazepam formulations have also been used by non-medical caregivers in out-of-hospital settings.
Diazepam nasal spray was developed by Neurelis, Inc. in the United States. Aculys holds exclusive development and commercialization rights in Japan and the Asia-Pacific region (excluding Greater China and Singapore). In 2020, the U.S. FDA approved diazepam nasal spray (marketed as VALTOCO®) for “the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.” Subsequently, in April 2025, the U.S. FDA extended the indication to include patients aged 2 years and older.
Asia-Pacific region includes: Australia, Brunei, Cambodia, Indonesia, South Korea, Laos, Malaysia, Myanmar, New Zealand, the Philippines, Thailand, Vietnam.
■About epilepsy
Epilepsy is a chronic brain disorder that causes loss of consciousness and/or convulsions (epileptic seizures) as the result of excessive electrical excitation of nerve cells (neurons) in the brain. An estimated 600,000 to 1,000,000, or 5 to 8 in 1,000 people in Japan have epilepsy. As treatment has advanced, many people with epilepsy are able to control their seizures with proper diagnoses and antiepileptic medications and are able to lead normal social lives; however, about 30% of patients, as well as their families and caregivers, still need to deal with frequent, repeated seizures.1,4
The causes, symptoms, and severity of epilepsy vary greatly from one individual patient to another, and similarly, epileptic seizures are diverse in nature from patient to patient. Among the diverse seizure types, some people experience seizures that recur many times a day or seizures that do not terminate after a certain period of time (status epilepticus). These patients are at increased risk of brain damage and reduced life expectancy.2 When repetitive seizures occur, people with epilepsy must seek emergency treatment by healthcare professionals. In Japan it takes on average 20—40 minutes from the time an emergency call is placed until a person is transferred to a hospital for treatment.3 An extensive overseas survey of patients, their families, and physicians has reported that recurrent epileptic seizures cause significant emotional, social, and financial burdens on patients and their families.5
■About Neurelis, Inc.
Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical needs. For more information about Neurelis, please visit www.neurelis.com.
■About Aculys Pharma, Inc.
Aculys Pharma is a clinical stage biopharmaceutical company that is pioneering ways to eliminate drug lag/drug loss in Japan, and is working to resolve social issues related to neurological and psychiatry diseases. Its corporate name was created from the philosophy of serving as a “Catalyst to Access.” Aiming to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals introduced from the US and European countries and provides innovations for better medical care to patients, their families, healthcare professionals, and society. Aculys Pharma is based in Tokyo, Japan, and was founded by Catalys Pacific.
Company name: Aculys Pharma, Inc.
Address: 2-14-4 Kita-Aoyama, Minato-ku, Tokyo, Japan
Representative: Hidemasa Tanigaki
Established: January 2021
URL: https://www.aculys.com
Information concerning pharmaceutical products (compound under development) contained herein is not intended as advertising or as medical advice, but for disclosure of management information.
References:
- Epidemiological survey on the prevalence, diagnosis, and treatment of epilepsy and issues to be solved to establish a healthcare system for the disease, 2013 https://mhlw-grants.niph.go.jp/project/22749 (Japanese only) (Accessed on Sep 2, 2024).
- Treatment guidelines for pediatric status epilepticus & pediatric convulsive status epilepticus 2023 (Japanese Society of Child Neurology) (Japanese only).
- Okazaki S, Nakagawa E, et al. Emergency management of pediatric epileptic seizures in non-hospital settings in Japan. Epilepsy Behav 2024;158:109914.
- Kwan P., Brodie, M.J. Early identification of refractory epilepsy. N. Engl. J. Med., 2000 Feb 3; 342(5): 314–
- Penovich, P.E., Buelow, J., Steinberg, et al. Burden of seizure clusters on patients with epilepsy and caregivers survey of patient, caregiver, and clinician perspectives. The Neurologist. 2017; 22: 207–