SAN DIEGO, Sept. 29, 2021 /PRNewswire/ -- Neurelis, Inc. announced today that it is presenting two posters at the 50th Annual Meeting of the Child Neurology Society in Boston from September 29 through October 2.
The first poster presents analyses from a Phase 3, long-term, open-label, repeat-dose safety study showing that VALTOCO® (diazepam nasal spray) demonstrated favorable long-term safety and tolerability results in children (aged 6-11) and adolescents (aged 12-17) who have epilepsy. The second poster presents additional primary safety data and a post-hoc analysis from the same Phase 3 study, showing that 89% of children and adolescent patients with epilepsy used a single dose of VALTOCO within a 24-hour period (after initial dose of VALTOCO was given). VALTOCO was approved in 2020 by the U.S. Food and Drug Administration (FDA) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters or acute repetitive seizures) that are distinct from an individual's usual seizure pattern in patients with epilepsy 6 years of age and older.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs at Neurelis, said, "Like in the adult population, these analyses provide further evidence that caregivers and physicians treating these younger seizure cluster patients can have confidence using VALTOCO, a convenient, nasally-administered rescue therapy that can be used on the go."
The details for the poster presentations are as follows and are available online to review here.
Abstract: Safety of Valtoco® (Diazepam Nasal Spray) in Children and Adolescents With Epilepsy: Final Subgroup Results From a Phase 3, Long-Term Open-Label, Repeat-Dose Safety Study
Abstract: Time to Second Doses in Children and Adolescents With Epilepsy Treated With Valtoco® (Diazepam Nasal Spray): Final Subgroup Results From a Phase 3, Open-Label, Repeat-Dose Safety Study
Dr. Rabinowicz said the latest scientific information on VALTOCO can be viewed at http://www.neurelismedicalaffairs.com
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's VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters or acute repetitive seizures) that are distinct from an individual's usual seizure pattern in patients with epilepsy 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 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). For more information on VALTOCO, please visit 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 (formerly known as BA-1049), an investigational, preclinical 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 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
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
Contraindications: VALTOCO is contraindicated in patients with:
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.
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.
For More Information:
SOURCE Neurelis, Inc.