– Data continue to support the unique clinical attributes for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults- Data also highlight that 88 percent of treated seizure episodes used a single dose of VALTOCO
SAN DIEGO, Oct. 16, 2020 /PRNewswire/ — Neurelis, Inc., announced today the company has four posters being presented at the 16th annual International Child Neurology Association Congress/49th annual Child Neurology Society Meeting. Due to the COVID-19 pandemic, posters are available online during the organizations’ virtual meetings.
Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the poster presentations continue to validate the safety, pharmacokinetics, and tolerability of VALTOCO® (diazepam nasal spray) in children with epilepsy aged 6 and older. VALTOCO was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, 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. In its approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO’s intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.
“The data continue to demonstrate that VALTOCO is an important treatment option for children with epilepsy suffering from seizure clusters,” Dr. Carrazana said.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, said, “It’s important to note that similar to what we have seen in adults, a single dose of VALTOCO was used in 88 percent of seizure episodes in children studied. This gives physicians and parents confidence that VALTOCO has a sustained response.”
The details for the poster presentations are as follows and are available online here; type VALTOCO in search bar to view.
Abstract: Time to Second Doses in Children With Epilepsy Treated With Valtoco® (Diazepam Nasal Spray): Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study
Abstract: Safety of Valtoco® (NRL-1; Diazepam Nasal Spray) in Children With Epilepsy: Updated Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study
Abstract: Importance of Seizure Time of Day in Children With Epilepsy Treated With Valtoco® (Diazepam Nasal Spray): Interim Subgroup Results From a Phase 3, Open-Label, Repeat Dose Safety Study
Abstract: Valtoco® (Diazepam Nasal Spray) in Children With Epilepsy Aged 6-11 Years: Interim Subgroup Results By Frequency of Usage From a Phase 3, Open-Label, 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 psychomotor agitation (PMA) symptoms outside of the medical setting. 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.
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SOURCE Neurelis, Inc.