SAN DIEGO, Dec. 2, 2021 /PRNewswire/ — Neurelis, Inc. will present a accumulating of 16 posters anecdotic safety, tolerability and capability after-effects empiric in trials evaluating VALTOCO® (diazepam nasal spray), and analytic trials advised to appraise VALTOCO as a abeyant accomplishment analysis in accommodating groups with unmet needs at the anniversary affair of the American Attack Society December 3-7 in Chicago.
Enrique Carrazana, M.D., Neurelis Chief Medical Officer, said the abiding analytic abstraction of VALTOCO® covered 4,390 access contest and provided admiring affirmation of its safety, capability and tolerability. VALTOCO was accustomed by the U.S. Food and Biologic Administering (FDA) in 2020 for the astute analysis of intermittent, stereotypic episodes of accepted access action (i.e., access clusters, astute repetitive seizures) that are audible from a patient’s accepted access arrangement in developed and pediatric patients 6 years of age and older. In acceding VALTOCO Drop Biologic Exclusivity, the FDA accustomed VALTOCO’s intranasal avenue of administering as clinically above to the ahead accustomed standard-of-care analysis (DIASTAT®, a abdominal gel conception of diazepam).
“Since the FDA approval of VALTOCO, we accept presented 65 posters at civic and all-embracing accurate meetings,” Dr. Carrazana said. “The analytic affirmation acknowledging VALTOCO’s account continues to arise and we accept underscores the charge for this accommodating citizenry to accept a convenient, reliable, on-the-go analysis for access clusters.”
Adrian L. Rabinowicz, M.D., Senior Vice President of Analytic Development and Medical Affairs, acclaimed that these analyses from the completed abiding Phase 3, open-label, repeat-dose assurance abstraction of VALTOCO articular similarities in assurance and capability after-effects empiric amid pediatric (ages 6 and over), boyish and developed populations enrolled in the study. He added that the assurance and capability after-effects empiric for VALTOCO additionally remained constant in analyses evaluating assertive subgroups of patients, including but not bound to patients with accessory clobazam use, epileptic encephalopathies and melancholia allergies/rhinitis. “Patient and caregiver advertisement adapted that VALTOCO was accessible to use and accelerated to administrate during the study,” Dr. Rabinowicz commented. He added that no new assurance signals emerged from the study, including no letters of respiratory depression. Patients enrolled in the abstraction did not arise to advance a altruism to again alternate use of VALTOCO over time.
The abiding assurance abstraction of VALTOCO, Dr. Rabinowicz said, additionally showed aliment in patient-reported Quality of Life in Attack scores, including numerical advance in the access anguish and amusing action subscale scores.
Additional posters to be presented focus on the following:
The capacity for the affiche presentations are as follows and are accessible online to analysis at the American Attack Society website.
Poster 1.286Diazepam Nasal Aerosol (Valtoco®) Added Dosage Administering Aural 4 Hours: A Citizenry Pharmacokinetic (PK) Analysis
Poster 1.287Study Architecture of an Open-Label Pharmacokinetic and Assurance Trial of Diazepam Nasal Aerosol (Valtoco®) in Accouchement 2?5 Years Old With Access Clusters
Poster 1.288Results for the Quality of Life in Attack Scale From a Long-Term Assurance Abstraction of Diazepam Nasal Aerosol for Access Clusters
Poster 1.293Adults Self-Administering Diazepam Nasal Aerosol for Access Clusters: After-effects on the Quality of Life in Attack Scale From a Phase 3, Open-Label, Repeat-Dose, Assurance Study
Poster 2.204Lack of Altruism With Diazepam Nasal Aerosol for Access Clusters Afterwards Abiding Use: Final After-effects From a Phase 3, Open-label, 12-month Repeat Dosage Assurance Study
Poster: 2.210Assessment of Abstraction Endpoints for Patients Discontinuing From a Phase 3, Long-Term, Open-Label, Repeat-Dose, Assurance Abstraction of Diazepam Nasal Aerosol for Astute Analysis of Access Clusters
Poster 2.211QoL and Analysis Satisfaction in a Long-Term Assurance Abstraction of Diazepam Nasal Aerosol for Access Clusters as Assessed by Patients and Their Caregivers
Poster 2.212Timing to Administering and Ease of Dosing of Diazepam Nasal Aerosol Accomplishment Analysis for Access Clusters: After-effects From a Phase 3, Long-Term Open-Label, Repeat-Dose Assurance Study
Poster 2.213Safety and Capability of Diazepam Nasal Aerosol in Pediatric Patients with Epileptic Encephalopathy: Final After-effects From a Phase 3, Open-Label, Repeat-Dose Assurance Study
Poster 2.214Lack of Impact of Melancholia Allergies or Rhinitis History on the Assurance of Diazepam Nasal Aerosol in Patients With Access Clusters: Final After-effects From a Long-Term, Phase 3, Open-Label, Repeat-Dose Assurance Study
Poster 2.215Evaluating Tolerability Endpoints Relevant to Clinicians and Patients in a Long-Term, Phase 3, Open-Label Repeat-Dose Assurance Abstraction of Diazepam Nasal Aerosol in Patients With Access Clusters
Poster 2.407Development of a Academy Nurse Analysis to Understand Accepted Practices, Barriers, and Needs for Analysis of Access Clusters in a Academy Setting
Poster 3.269Quality of Life in Attack Scale for Accepted and Infrequent Users of Diazepam Nasal Aerosol for Access Clusters in a Phase 3, Open-Label, Repeat-Dose Assurance Study
Poster 3.274Safety and Time to Added Doses in Age Subgroups of Patients With Access Clusters Advised With Diazepam Nasal Aerosol in a Phase 3, Open-Label, Repeat-Dose Assurance Study
Poster 3.275Safety of a Added Dosage of Diazepam Nasal Aerosol Aural 4 Hours in Patients With Access Clusters: Final After-effects From a Long-Term, Phase 3, Open-Label, Repeat-Dose Assurance Study
Poster 3.284Evaluation of Diazepam Nasal Aerosol in Patients with Access Clusters Concomitantly Accepting Clobazam: A Subgroup Analysis from a Completed Phase 3, Long-term, Open-label Assurance Study
About Neurelis
Neurelis, Inc., is a absolutely chip neuroscience aggregation focused on the development and commercialization of analysis for the analysis of attack and drop neurologic disorders characterized by aerial unmet medical need. In 2020, the FDA accustomed Neurelis’ VALTOCO® (diazepam nasal spray) as an astute analysis of intermittent, stereotypic episodes of accepted access action (i.e., access clusters, astute repetitive seizures) that are audible from an individual’s accepted access arrangement in developed and pediatric patients 6 years of age and older. VALTOCO is a proprietary conception of diazepam accumulation the science of INTRAVAIL®. INTRAVAIL’s transmucosal assimilation accessory technology enables the noninvasive commitment of a ample ambit of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Biologic Administering additionally accepted Neurelis Drop Biologic Exclusivity and accustomed VALTOCO’s intranasal avenue of administering as a clinically above accession to accommodating affliction over the ahead accustomed standard-of-care analysis (a abdominal gel conception of diazepam). For added advice on VALTOCO, amuse appointment www.valtoco.com. In accession to VALTOCO, Neurelis is developing NRL-2 for alternate use to ascendancy astute agitation attacks, NRL-3 as a noninvasive astute analysis to stop seizures that accept progressed to cachet epilepticus, and NRL-4 as a noninvasive accomplishment analysis to abode the accretion of astute agitation affection associated with schizophrenia and bipolar 1 aberration in adults. In addition, Neurelis is developing NRL-1049, an investigational, preclinical date baby atom Rho kinase (ROCK) inhibitor, for the analysis of bookish alveolate malformations (CCMs), a attenuate ataxia of the axial afraid arrangement (CNS). For added advice on Neurelis, amuse appointment www.neurelis.com. For the latest accurate advice on VALTOCO, amuse appointment www.neurelismedicalaffairs.com.
Important Assurance Advice about VALTOCO:
IndicationVALTOCO® (diazepam nasal spray) is adumbrated for the astute analysis of intermittent, stereotypic episodes of accepted access action (ie, access clusters, astute repetitive seizures) that are audible from a patient’s accepted access arrangement in patients with attack 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 Afraid Arrangement (CNS) Depression
Benzodiazepines, including VALTOCO, may aftermath CNS depression. Caution patients adjoin agreeable in chancy activities acute brainy alertness, such as operating machinery, alive a motor vehicle, or benumbed a bicycle, until the furnishings of the drug, such as drowsiness, accept subsided, and as their medical action permits.
The abeyant for a accessory CNS-depressant aftereffect back VALTOCO is acclimated with booze or added CNS depressants charge be considered, and adapted recommendations fabricated to the accommodating and/or affliction partner.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including VALTOCO, access the accident of baleful anticipation and behavior. Patients advised with any AED for any adumbration should be monitored for the actualization or deepening of depression, baleful thoughts or behavior, and/or abnormal changes in affection or behavior.
Glaucoma
Benzodiazepines, including VALTOCO, can access intraocular burden in patients with glaucoma. VALTOCO may abandoned be acclimated in patients with open-angle glaucoma abandoned if they are accepting adapted therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.
Risk of Austere Adverse Reactions in Breed due to Benzyl Booze Preservative
VALTOCO is not accustomed for use in neonates or infants. Austere and baleful adverse reactions, including “gasping syndrome”, can action in neonates and low-birth-weight breed advised with benzyl alcohol-preserved drugs, including VALTOCO. The “gasping syndrome” is characterized by axial afraid arrangement depression, metabolic acidosis, and asthmatic respirations. The minimum bulk of benzyl booze at which austere adverse reactions may action is not known.
Adverse Reactions
The best accepted adverse reactions (at atomic 4%) were somnolence, headache, and nasal discomfort.
Diazepam, the alive additive in VALTOCO, is a Schedule IV controlled substance.
To address SUSPECTED ADVERSE REACTIONS, acquaintance Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please apprehend abounding Prescribing Information, including Boxed Warning, for added important assurance information.
For Added Information:Mark [email protected] 858-251-2100
SOURCE Neurelis, Inc.
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