-- Clinical studies support effectiveness and safety profile for Neurelis' lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older
-- Data presented at AMCP shows that just a single dose of VALTOCO was needed in 87.4% of seizure clusters
-- Company also announced that payers/insurers and managed care plans now cover 276 million lives for VALTOCO
SAN DIEGO, April 12, 2021 /PRNewswire/ -- Neurelis, Inc., announced today that it is presenting two posters at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting being held virtually from April 12 through April 16.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, said the clinical study of VALTOCO® (diazepam nasal spray), which covers 4,390 seizure events, continues to demonstrate its safety, effectiveness and tolerability. VALTOCO was approved by the U.S. Food and Drug Administration (FDA) in 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 granting VALTOCO Orphan Drug Exclusivity, the FDA recognized VALTOCO's intranasal route of administration as clinically superior to DIASTAT® (diazepam rectal gel), the previously approved standard of care treatment.
Dr. Rabinowicz commented, "Seizure clusters generally occur over a period of 24 hours or longer. These data presented at AMCP shows that just a single dose of VALTOCO was needed in 87.4% of seizure clusters, a proxy measurement for efficacy. Coupled with its safety and tolerability, these data should provide physicians, patients, and caregivers confidence that VALTOCO is a ready-to-use, reliable treatment for episodes of frequent seizure activity that can be used where and when needed."
The details for the poster presentations are as follows and are available online to review here.
Abstract G31: Time to Second Doses in Emergency Seizure Patients Treated With Valtoco® (diazepam nasal spray) Across 24 Hours: Subgroup Results From a Completed Phase 3, Open-label, Repeat Dose Safety Study
Abstract G34: Safety Profile of Valtoco® (diazepam nasal spray) in Patients With Epilepsy: Final Results From a Phase 3, Open-Label, 12-Month Repeat Dose Safety Study
Dr. Rabinowicz said the latest scientific information on VALTOCO can be viewed at http://www.neurelismedicalaffairs.com.
Chuck DeWildt, Chief Commercial Officer, announced in conjunction with the AMCP Annual Meeting that insurers and managed care plans now provide coverage for 276 million lives for VALTOCO. "Payers understand the importance of access to an important medication like VALTOCO which addresses a large unmet need in the epilepsy community," DeWildt said.
DeWildt added that Neurelis is dedicated to ensuring access to VALTOCO to everyone who needs it. He said Neurelis has a patient assistance program to support eligible uninsured patients, including those who might have lost insurance coverage due to the COVID-19 pandemic. For more information on the Neurelis patient assistance program, please visit http://www.myNEURELIS.com.
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 its approval of VALTOCO, the U.S. Food and Drug Administration 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). 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 FDA approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, 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 acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. 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
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for 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.
The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.
The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO.
Contraindications: VALTOCO is contraindicated in patients with:
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.
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.
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SOURCE Neurelis, Inc.