Acute repetitive seizure

The Australian-developed Minder system is an implantable device for continuous monitoring of brain activity in patients with epilepsy, developed to address the shortcomings in current electroencephalogram technologies The FDA has granted authorisation for Minder under its De Novo pathway creating a new classification of device, allowing for marketing and sale of the device in the US for patients with drug resistant epilepsy Epiminder intends to launch Minder in the US during H2 2025 MELBOURNE, Australia and DALLAS, April 22, 2025 /PRNewswire/ -- Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary implantable continuous electroencephalogram monitoring system (iCEMTM) for patients with epilepsy. Minder has also been designated as a Breakthrough Technology by the FDA, recognising its potential to provide more effective diagnosis and management for people living with epilepsy. This De Novo authorization is significant as it creates a new classification of device which underscores both the innovation and the clinical validation behind Minder. Without accurate diagnosis and monitoring, sustained and effective management of epilepsy can be challenging. Minder has been developed to address the shortcomings in current electroencephalogram (EEG) technologies, providing reliable and actionable diagnostic data for more patients and therefore better enabling their prospects for successful epilepsy treatment. Rohan Hoare PhD, CEO of Epiminder, said: " By extending the monitoring window of an EEG from days using current technologies to months or even years with Minder, we can deliver unprecedented access to a high-fidelity stream of continuous EEG data to health care professionals and their patients. The FDA's clearance of Minder is a significant milestone for Epiminder and more importantly for the 52 million people around the world who have epilepsy. As the first and only implantable continuous EEG monitor approved in US, Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery. Looking ahead, Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting." Epiminder intends to formally launch Minder in the US during H2 2025 undertaking a phased commercial roll out into leading epilepsy centres as part of a program to demonstrate the clinical utility of the system. Professor Robert Fisher MD, PhD, Director of the Stanford Epilepsy Center, past-President of the American Epilepsy Society, and Chair of the Data Safety Monitoring Board for the UMPIRE trial, said: "One of the greatest difficulties in caring for people with epilepsy is the lack of accurate information about a patient's seizures. Seizure diaries are of limited effectiveness. Minder can greatly improve seizure tracking and therefore seizure management. It will fill the significant gap in current EEG technologies, providing clinicians like me continuous and accurate data. By having a more complete picture, we can be more precise in our diagnoses, better able to rapidly adjust medication or neuromodulation regimens and identify patients for potential non-drug or surgical treatments. The result will be a reduction in the huge burden of drug resistant epilepsy." The safety and effectiveness of Minder was validated through Epiminder's UMPIRE clinical study, a multi-centre prospective, open design, case-controlled comparator trial that was undertaken in leading Australian hospitals between 2019 and 2023. The results of UMPIRE were used to support Epiminder's successful FDA application. Professor Mark Cook MD MBBS FRACP FRCP (London), Epiminder's Founder and Chief Medical Officer, said: "The results from UMPIRE exceeded our expectations and demonstrated Minder's ability to capture high-quality EEG data continuously for extended periods, including a groundbreaking five-year continuous recording in one participant. Minder delivered actionable clinical insights for nearly 90 percent of study participants, highlighting the real-life benefits that Epiminder's best-in-class iCEM can deliver relative to the current standard of care." Epilepsy is one of the most common serious chronic neurological disorders, affecting approximately 52 million people worldwide including 250,000 Australians and 3.4 million Americans. It is a neurological condition where a person experiences recurrent seizures caused by abnormal electrical activity in the brain. Seizures can present with a variety of clinical manifestations; some involve motor symptoms, such as intense muscle contractions, while others, such as absence or focal impaired awareness seizures, may present with subtle or no outward physical signs. The occurrence of seizures varies in frequency among patients, from less than one a year to several a day. Follow Epiminder on LinkedIn and explore for more information. About Minder Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities. Minder's long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions. About Epiminder Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited. Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States. Contact: Matt Wright, [email protected] SOURCE Epiminder WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Nasal spray tech facilitates the delivery of proteins, small-molecule drugs and peptides. Credit: 1777177/Shutterstock. The US Food and Drug Administration (FDA) has approved Neurelis’ diazepam nasal spray, Valtoco, for the short-term treatment of acute repetitive seizures, also referred to as seizure clusters, in patients aged two years and above. The spray leverages a transmucosal absorption enhancement technology, Intravail, for noninvasive intranasal diazepam delivery. This technology facilitates the delivery of proteins, small-molecule drugs and peptides. The FDA had previously awarded the treatment its orphan drug exclusivity designation by recognising the superiority of Valtoco’s intranasal formulation to diazepam’s rectal gel formulation. 3.4 million US adults with epilepsy and 400,000 paediatric patients experience acute repetitive seizures. The Phase I/IIa trial assessing the pharmacokinetics and safety of the spray has shown that it is effective and safe via nasal administration for subjects aged two years and above. Neurelis develops and commercialises treatments for epilepsy and neurological conditions with unmet medical needs. The spray is not authorised for use in infants or neonates. The use of benzyl alcohol-preserved medications in these populations can lead to fatal adverse events, including gasping syndrome, marked by metabolic acidosis, central nervous system depression and gasping respiratory patterns. Neurelis CEO and founder Craig Chambliss stated: “We are so grateful for all those who participated in the clinical study to enable Valtoco to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures”.

VALTOCO maintains orphan drug exclusivity for VALTOCO to treat episodes of frequent seizures SAN DIEGO, April 16, 2025 /PRNewswire/ -- Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) for short-term treatment of seizure clusters (also known as "acute repetitive seizures") that are different from a person's normal seizure pattern in people 2 years of age and older. VALTOCO is a proprietary formulation which utilizes an absorption enhancement technology, INTRAVAIL®, to enable the noninvasive, enhanced intranasal delivery of diazepam. The intranasal formulation of Neurelis' VALTOCO was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation. "We are so grateful for all those who participated in the clinical study to enable VALTOCO to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures," said Craig Chambliss, Neurelis Founder and CEO. "The FDA's decision to approve VALTOCO for use in early childhood highlights the established balanced safety and efficacy profile," commented Eric Segal, MD, Director of Pediatric Epilepsy at Northeast Regional Epilepsy Group and Hackensack University Medical Center. "VALTOCO fills a large unmet need for children with seizures and their families. I am hopeful that this product will improve quality of life for this specific population." Approximately 3.4 million people in the U.S. have epilepsy, including 400,000 children. While chronic epilepsy can be controlled by medications, some patients are at risk of episodes of frequent seizures, or acute repetitive seizures. "For children who have episodes of frequent seizures, the current standard of care requiring rectal administration of medication to stop a seizure can be a significant challenge for caregivers and children alike," added Jurriaan M Peters, MD, PhD, Director, Localization Laboratory, Division of Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, and Associate Professor in Neurology at Harvard Medical School. "Approval of an immediate-use intranasal diazepam treatment that can be given at any time, even while a child is actively seizing, in this young age group is an important advance for the epilepsy community." Data from the phase 1/2a clinical study evaluating safety and pharmacokinetics demonstrated that VALTOCO is safe and effective with easy nasal administration for patients aged 2 years and older who have episodes of frequent seizures. The company presented data on the study at the 53rd Annual Child Neurology Society Meeting in November 2024 in San Diego and Annual American Epilepsy Society Meeting in December 2024 in Los Angeles. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 2 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED