NRL-3

SAN DIEGO, Oct. 13, 2022 /PRNewswire/ -- Neurelis, Inc., today announced findings from a novel, investigational analysis of the time between seizure clusters in pediatric patients using VALTOCO® (diazepam nasal spray). Findings indicate a significant increase in these intervals, or SEIzure interVAL (SEIVAL) data, over a 12-month period. This data will be presented at the 51st Child Neurology Society Annual Meeting in Cincinnati, Ohio, Oct. 12-15, 2022. VALTOCO, a nasal spray for acute treatment of episodes of frequent seizures in adult and pediatric patients 6 years of age and older, was approved by the U.S. Food and Drug Administration (FDA) in 2020. An additional poster presents long-term safety data of VALTOCO for treating seizure clusters in patients with Lennox-Gastaut Syndrome (LGS) and other pediatric epileptic encephalopathies, which typically appears in infancy or early childhood. "The SEIVAL data is promising and warrants further study to determine If we can lengthen the time between seizure clusters and enable patients to have fewer of these emergencies overall," said Adrian Rabinowicz, M.D., SVP Clinical Development and Medical Affairs. "The LGS findings also are an encouraging sign that diazepam nasal spray can be used safely in LGS patients, who often are on other chronic benzodiazepine medications." Key Findings from these analyses include: The pediatric patient subgroup, ages 6 to 17, showed the same SEIVAL pattern that was reported in adults. For data across all Periods 1-4 (n=32), mean SEIVAL in this group increased from 13 days (Period 1) to 25.9 days (Period 4), and no effect of concomitant anti-seizure medication change was observed. Of the 163 treated patients, treatment-emergent events (TEAEs) were reported in 6 of 7 (85.7%) patients with LGS and 57 of 64 (89.1%) pediatric patients with encephalopathies. The only treatment-related TEAEs in ≥2 patients in either group was epistaxis (n=2). There were no serious TEAEs and no discontinuations due to TEAEs or deaths in either group. Poster Presentation Information Examination of SEIzure interVAL data (SEIVAL) Over Time in Pediatric Patients in a Phase 3, Long-Term Open-Label, Repeat-Dose Safety Study of Diazepam Nasal Spray for the Treatment of Seizure Clusters (Poster #42) Do Patients with Lennox-Gastaut Syndrome Respond Differently to Diazepam Nasal Spray (VALTOCO®) than Other Patients with Pediatric Encephalopathies? Final Safety and Effectiveness Results From a Phase 3, Long-Term Open-Label, Repeat-Dose Safety Study (Poster #43, Selected as a guided poster tour) About Neurelis Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA 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 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail's transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit http://www.valtoco.com/. In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, pre-clinical stage small molecule 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 http://www.neurelis.com/. For the latest scientific information on VALTOCO, please visit http://www.neurelismedicalaffairs.com/. 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 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. 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. 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 (www.fda.gov/medwatch). Please see full Prescribing Information, including Boxed Warning, for additional important safety information.

Analysis of 12-month, Phase 3 study shows 2-fold increase in time between VALTOCO treated seizure clusters, or SEIzure interVAL (SEIVAL) SAN DIEGO, Oct. 12, 2022 /PRNewswire/ -- Neurelis, Inc., a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, today announced it will present an analysis of a Phase 3 safety study of VALTOCO® (diazepam nasal spray) CIV at the 2022 Annual Meeting of the Academy of Managed Care Pharmacy (AMCP NEXUS), Oct. 14 to 22, in National Harbor, MD. The poster presentation summarizes results indicating a 2-fold increase in time between treated seizure clusters, or SEIzure interVAL (SEIVAL), associated with use of VALTOCO. "The increased time between seizure clusters may show a reduced seizure burden and result in reduced treatment utilization over time," said Adrian Rabinowicz, MD, SVP Clinical Development and Medical Affairs. "We remain committed to improving seizure control for people with epilepsy and believe these findings offer encouraging news for patients using VALTOCO and intend to conduct further research in this area." VALTOCO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizure clusters in adults and children 6 years of age and older. The analysis of the 12-month, open-label, repeat-dose study assessed safety of diazepam nasal spray in patients ages 6 to 65 years in need of benzodiazepine rescue. The study enrolled 175 patients, 163 of whom received one or more doses of diazepam nasal spray. Time between seizure clusters, or SEIVAL, was evaluated using 90-day periods. Findings showed that mean SEIVAL change from Period 1 was significant in Periods 2, 3, and 4. SEIVAL increased from 13.9 days (Period 1) to 26.8 days (Period 4). Similar SEIVAL patterns were observed irrespective of length of exposure (<12 or ≥12 months). Poster presentation details: Thursday, Oct. 13 from 11:30 AM - 1 PM, Poster #G22 About Neurelis Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA 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 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail's transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit . In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, pre-clinical stage small molecule 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 . For the latest scientific information on VALTOCO, 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 6 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. 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 see full Prescribing Information, including Boxed Warning, for additional important safety information. Contacts: Neurelis: Brittany Bradrick, Chief Financial Officer, +1 858 251 2135 Media: Erich Sandoval, Finn Partners, + 1 917 497 2867 SOURCE Neurelis, Inc.