Neurelis Initiates Study Of VALTOCO (diazepam nasal spray) In Children With Seizure Clusters Aged Two To Five
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Pediatric
FDA
- VALTOCO is currently approved by the 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
SAN DIEGO, Sept. 20, 2021 /PRNewswire/ -- Neurelis, Inc. announced today that it has initiated a clinical program to investigate the use of VALTOCO® (diazepam nasal spray) in children with epilepsy aged two to five as a treatment for seizure clusters. VALTOCO is currently approved 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. Safety and effectiveness of VALTOCO in pediatric patients below the age of 6 have not been established.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs at Neurelis, said there is a "high unmet need" in the two to five-year-old age group for an alternative treatment. "Currently the only FDA-approved option for these children is a rectally administered version of diazepam," Dr. Rabinowicz said. "We understand that caregivers and physicians treating these younger seizure cluster patients could benefit from having a more convenient, nasally-administered rescue therapy that can be used on the go."
Sunita Misra, M.D., Ph.D., Neurelis Medical Director, said the clinical program, named Stellina™, is a Phase 1/2a open-label pharmacokinetics study of VALTOCO with an open-label safety period in pediatric epilepsy patients from two to five years of age. "The goal of this study is to assess the pharmacokinetics of VALTOCO in this age group as well as to assess its safety and tolerability," Dr. Misra said. "We are grateful to be partnering with a team of exceptional physicians to lead our research effort."
About NeurelisNeurelis, 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. For the latest scientific information on VALTOCO, please visit www.neurelismedicalaffairs.com.
Important Safety Information about VALTOCO:
IndicationVALTOCO® (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) DepressionBenzodiazepines, 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 IdeationAntiepileptic 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.
GlaucomaBenzodiazepines, 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 PreservativeVALTOCO 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 ReactionsThe 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:Mark Leonard[email protected] 858-251-2100
SOURCE Neurelis, Inc.
https://www.neurelis.com
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