SAN DIEGO, December 4, 2020 / PRNewswire / – Neurelis, Inc., today announced that the company has presented 12 posters at the American Epilepsy Society Annual Meeting, which is being held virtually from December 4 to December 8.
Chief physician of Neurelis Enrique Carrazana, MD, said the clinical program continues to provide a significant amount of data on the use of VALTOCO® (diazepam nasal spray) in children with epilepsy aged 6 years and older. VALTOCO was approved earlier this year by the United States Food and Drug Administration (FDA) for the acute treatment of intermittent, stereotypical episodes of frequent seizure activity (i.e., pediatric patients 6 years of age and older. “To In recent years, we have been able to compile a large body of data which continues to demonstrate that VALTOCO is generally safe and effective to use and is an important treatment option for people with epilepsy with seizures, ”said Dr Carrazana.
Adrian L. Rabinowicz, MD, senior vice president of clinical development and medical affairs, said the data presented to AES represents 3,370 seizure episodes. Among the data, Dr Rabinowicz said, is validation that VALTOCO can be self-administered. “Taken together, all of the data should give physicians, patients and caregivers reassurance that VALTOCO is a reliable, ready-to-use treatment for episodes of frequent seizure activity that can be used where and when needed. necessary, ”he noted.
The details of the poster presentations are as follows and are available online for review (search by poster number) here
Abstract No. 122: Assessment of the impact of frequency of use on the safety and tolerability of diazepam nasal spray in subjects with epilepsy: interim results from a phase 3, open, repeated-dose study
Abstract No. 337: Evaluation of diazepam nasal spray in patients with epilepsy concomitantly using maintenance benzodiazepines: interim review of a long-term open-label phase 3 safety study
Abstract No. 553: Time to second dose in emergency crisis patients treated with Valtoco® (diazepam nasal spray) Over 24 hours: Interim subgroup results of a phase 3, open-label, repeated-dose safety study
Abstract No. 554: Exploring the impact of the need for a second dose of rescue therapy for crisis groups 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 groups: interim results from a phase 3, open-label, repeated-dose safety study 12 months
Summary # 559: Efficiency of Valtoco® (diazepam nasal spray) Rescue therapy for groups of seizures based on safety analysis after long-term use: interim results from a phase 3, open-label, repeated-dose safety study of 12 months
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 12-Month Open-label, Repeat-Dose Phase 3 Safety Study
Abstract No. 561: Caregiver experience with diazepam nasal spray for seizure groups: results reported by caregivers from an exit survey from a phase 3, open-label, repeated-dose safety study
Abstract No. 562: Review of Patient Experience with Diazepam Nasal Spray for Seizure Groups: Patient-Reported Results from a Phase 3, Open-Label, Repeat-Dose Safety Study Discharge Investigation
Abstract No. 563: Characteristics of Patients who Self-Administered Diazepam Nasal Spray for the Epileptic Groups: Interim Results from a Phase 3 Open-Label Repeat-Dose Safety Study
Abstract No. 761: Time of day of onset of seizure clusters in patients with epilepsy treated with diazepam nasal spray: interim results from a phase 3, open-label, repeated-dose safety study
Abstract No. 982: Valtoco Security Profile® (diazepam nasal spray) in patients with epilepsy: interim results from a repeat-dose, phase 3, open-label, 12-month safety study
VALTOCO is a proprietary formulation of diazepam incorporating the science of Work®. Intravail transmucosal absorption enhancement technology enables non-invasive delivery of a wide range of protein, peptide and small molecule drugs. In its approval of VALTOCO, the FDA also granted orphan drug exclusivity to Neurelis and recognized the intranasal route of administration of VALTOCO as a clinically superior contribution to patient care over the previously approved standard therapy (a formulation of diazepam rectal gel). In a long-term, open-label, repeated dose clinical trial, the safety of VALTOCO has been evaluated and over 4000 seizures have been treated. The clinical trial included adult and pediatric patients aged 6 years and older. VALTOCO was generally safe and well tolerated in clinical studies. The most common side effects of diazepam (at least 4%) were drowsiness, headache, and nasal discomfort. For more information on VALTOCO, please visit www.valtoco.com.
Neurelis, Inc., is an innovation-driven neuroscience company that offers a highly differentiated approach to targeting unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. At January 10, 2020, the United States Food and Drug Administration (FDA) has approved Neurelis’ VALTOCO® (diazepam nasal spray) as an acute treatment for intermittent, stereotypical episodes of frequent epileptic activity (i.e., epileptic clusters, acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in adult patients and pediatric patients 6 years of age and over. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as an acute non-invasive therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a non-invasive rescue therapy to treat escalating symptoms of acute agitation associated with schizophrenia and bipolar mania 1 in adults. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary non-invasive 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 stereotypical, intermittent episodes of frequent seizure activity (i.e., epileptic activity).
IMPORTANT SAFETY INFORMATION
RISK OF CONCURRENT USE WITH OPIODS
Concomitant use of benzodiazepines and opioids can 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 times to the minimum required
- Monitor patients for signs and symptoms of respiratory depression and sedation
Contraindications: VALTOCO is contraindicated in patients with:
- Known hypersensitivity to diazepam
- Acute angle-closure glaucoma
Central nervous system (CNS) depression
Benzodiazepines, including VALTOCO, can cause CNS depression. Warn patients not to engage 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 their state of health permits.
The potential for a synergistic CNS depressant effect when VALTOCO is used with alcohol or other CNS depressants should 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 thoughts and behavior. Patients treated with an AED for any indication should be monitored for new or worsening depression, suicidal thoughts or behavior, and / or unusual changes in mood or behavior. Advise patients and caregivers to be alert to these behavioral changes and to report them immediately to a healthcare practitioner.
Benzodiazepines, including VALTOCO, may increase intraocular pressure in patients with glaucoma. VALTOCO can only be used in patients with open angle glaucoma if they are receiving appropriate treatment. VALTOCO is contraindicated in patients with narrow-angle glaucoma.
Risk of serious side effects in infants due to preservative benzyl alcohol
VALTOCO is not approved for use in newborns or infants. Serious and fatal side effects, including “panting syndrome”, can occur in newborns and low birth weight infants treated with medicines containing benzyl alcohol, including VALTOCO. “Panting syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping breaths. The minimum amount of benzyl alcohol at which serious side effects can occur is not known.
The most common side effects (at least 4%) were drowsiness, headache and nasal discomfort.
Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.
To report SUSPECTED SIDE EFFECTS, contact Neurelis, Inc. at 1-866-696-3873 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please read Complete prescribing information, including the boxed warning, for additional important safety information.
For more information:
SOURCE Neurelis, Inc.