– Data supports pharmacokinetic and safety profile 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 further highlights the permeation enhancer potency of Intravail® for both small and large molecules; Intravail is a key component of VALTOCO formulation
SAN DIEGO, May 20, 2020 /PRNewswire/ — Neurelis, Inc., announced today the company has nine total posters accepted for the annual meetings of the American Association of Neuroscience Nurses (AANN), the Academy of Managed Care Pharmacy (AMCP) and the American Academy of Neurology (AAN). The posters are all available for review online due to the cancellation of the organizations’ annual meetings because of the COVID-19 pandemic.
Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the poster presentations continue to validate the safety, pharmacokinetic, and tolerability of VALTOCO® (diazepam nasal spray). 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 of VALTOCO, 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).
“During the clinical development of VALTOCO, more than 4,000 seizures were treated,” Dr. Carrazana said. “As a result, we have been able to accumulate a wealth of administration and safety data of VALTOCO use in patients with epilepsy experiencing seizure clusters.”
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, commented, “We are very pleased that AANN, AMCP, and AAN accepted these peer-reviewed posters that further validate the rigorous science behind VALTOCO as well as Intravail. These presentations have been made possible by the participation of our investigators, their dedicated staff and, most significantly, the patients who participated in these important studies.”
The details for the poster presentations are as follows:
American Association of Neuroscience Nurses:
Abstract: Safety and Tolerability of NRL-1, an Intranasal Formulation of Diazepam, in Relationship to Usage Frequency, in Subjects with Epilepsy: Interim Results From a Phase 3, Open-label, Repeat Dose Study; click here to view
Academy of Managed Care Pharmacy:
Abstract: Safety of Valtoco® (NRL-1; diazepam nasal spray) in Patients with Epilepsy: Interim Results from a Phase 3, Open-Label, 12-Month Repeat Dose Study; click here to view
Abstract: Need for a Second Dose for the Treatment of Seizure Clusters: Impact on Resource Utilization; click here to view
American Academy of Neurology:
Abstract: Low Rate of Medication Errors Supports the Ability of Patients and Caregivers to Administer NRL?1, an Intranasal Formulation of Diazepam: Interim Results from a Phase 3, Open-Label, Repeat Dose Study; click here to view
Abstract: Pharmacokinetics of Intravail® A3 (n?dodecyl?beta?D maltoside), a Mucosal Absorption Enabler, After Intranasal Administration of NRL?1 in Patients with Epilepsy; click here to view
Abstract: Pharmacokinetics and Safety of Valtoco® (NRL?1; diazepam nasal spray) in Patients With Epilepsy During Seizure (Ictal/Peri?ictal) and Non? seizure (Inter?ictal) Conditions: Results from a Phase 1, Open?Label Study; click here to view
Abstract: Safety and Tolerability of NRL? 1, an Intranasal Formulation of Diazepam, in Relationship to Usage Frequency in Subjects With Epilepsy: Interim Results From a Phase 3, Open?label, Repeat Dose Study; click here to view
Abstract: Safety and Tolerability of NRL? 1, an Intranasal Formulation of Diazepam, in Subjects with Epilepsy in a Phase 1, Open? Label Study: Focus on Adverse Events Relevant to Clinicians and Patients; click here to view
Abstract: Effectiveness and Safety of Valtoco® (NRL?1; diazepam nasal spray) in Patients With Epilepsy and a History of Seasonal Allergies: Interim Results From a Phase 3, Open? Label, 12?Month Repeat Dose Study; click here to view
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 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 (i.e., 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 see full Prescribing Information, including Boxed Warning, for additional important safety information.
For More Information:
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SOURCE Neurelis, Inc.