Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society
— Abstracts continue to demonstrate the safety and unique clinical attributes of Neurelis' lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for episodes of frequent seizure activity in pediatric patients 6 years of age and older, adolescents, and adults
— Data also highlight the ability for patients to self-administer VALTOCO during a seizure episode
SAN DIEGO, CA – December 4, 2020 – Neurelis, Inc., announced today the company has 12 posters being presented at the American Epilepsy Society Annual Meeting being held virtually from December 4 through December 8.
Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the clinical program continues to provide a significant amount of data around the use of VALTOCO® (diazepam nasal spray) in children with epilepsy aged 6 and older. VALTOCO was approved earlier this year by the U.S. Food and Drug Administration (FDA) 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 adult and pediatric patients 6 years of age and older. "Over the past few years we have been able to compile a large dataset that continues to demonstrate that VALTOCO is generally safe and effective to use and is an important treatment option for people with epilepsy suffering from seizure clusters," Dr. Carrazana said.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, said the data presented at AES represent 3,370 seizure episodes. Included in the data, Dr. Rabinowicz said, is validation that VALTOCO can be self-administered. "In its totality, all the data should provide physicians, patients and caregivers confidence that VALTOCO is a ready-to-use, reliable treatment for episodes of frequent seizure activity that can be used where and when needed," he noted.
The details for the poster presentations are as follows and are available online to review (searchable by poster number) here:
Abstract No. 122: Evaluation of the Impact of Usage Frequency on Safety and Tolerability of Diazepam Nasal Spray in Subjects With Epilepsy: Interim Results From a Phase 3, Open-label, Repeat Dose Study
Abstract No. 337: Evaluation of Diazepam Nasal Spray in Patients with Epilepsy Concomitantly Using Maintenance Benzodiazepines: Interim Analysis from a Phase 3, Long-term, Open-label Safety Study
Abstract No. 553: Time to Second Doses in Emergency Seizure Patients Treated With Valtoco® (diazepam nasal spray) Across 24 hours: Interim Subgroup Results From a Phase 3, Open-label, Repeat Dose Safety Study
Abstract No. 554: Exploring the Impact of Need for a Second Dose of Rescue Therapy for Seizure Clusters on Healthcare Utilization
Abstract No. 558: Use of a Second Dose of Diazepam Nasal Spray Within 4 Hours and Effect on the Safety Profile in Patients with Seizure Clusters: Interim Results from a Phase 3, Open-label, 12-Month Repeat Dose Safety Study
Abstract No. 559: Effectiveness of Valtoco® (diazepam nasal spray) Rescue Therapy for Seizure Clusters Based on Analysis of Tolerance After Long-term Use: Interim Results From a Phase 3, Open-label, 12-month Repeat Dose Safety Study
Abstract No. 560: Impact of Seasonal Changes on the Safety and Tolerability of Diazepam Nasal Spray in Patients with Allergies or Rhinitis: Updated Interim Results From a Phase 3, Open-label, 12-Month Repeat Dose Safety Study
Abstract No. 561: Caregiver Experience With Diazepam Nasal Spray for Seizure Clusters: Caregiver-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study
Abstract No. 562: Examining the Patient Experience With Diazepam Nasal Spray for Seizure Clusters: Patient-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study
Abstract No. 563: Characteristics of Patients Who Self-Administered Diazepam Nasal Spray for Seizure Clusters: Interim Results From a Phase 3, Open-label, Repeat Dose Safety Study
Abstract No. 761: Time of Day of Occurrence of Seizure Clusters in Patients With Epilepsy Treated With Diazepam Nasal Spray: Interim Results From a Phase 3, Open-label, Repeat Dose Safety Study
Abstract No. 982: Safety Profile of Valtoco® (diazepam nasal spray) in Patients With Epilepsy: Interim Results From a Phase 3, Open-label, 12-Month Repeat Dose Safety Study
VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail®. Intravail 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 FDA 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). In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated and more than 4,000 seizures were treated. The clinical trial included adult and pediatric patients aged 6 and older. VALTOCO was generally safe and well tolerated during clinical studies. The most common adverse reactions for diazepam (at least 4%) were somnolence, headache, and nasal discomfort. For more information on VALTOCO, please visit www.valtoco.com.
Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. On January 10, 2020, the U.S. Food and Drug Administration (FDA) approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, 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. In addition to VALTOCO, the company 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. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary, noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules, and small molecules. For more information on Neurelis, please visit www.neurelis.com.
Important Safety Information about VALTOCO:
VALTOCO® (diazepam nasal spray) is indicated 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.
IMPORTANT SAFETY INFORMATION
RISK FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in 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
Contraindications: VALTOCO is contraindicated in patients with:
- Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.
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.
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 read full Prescribing Information, including Boxed Warning, for additional important safety information.