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SAN DIEGO, April 19, 2021 /PRNewswire/ -- Neurelis, Inc., announced today that it is presenting five posters at the American Academy of Neurology (AAN) Annual Meeting being held virtually from April 17 through April 22. 

Enrique Carrazana, M.D., Neurelis Chief Medical Officer, 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 the previously approved standard of care treatment (DIASTAT^®, a rectal gel formulation of diazepam).

Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, commented, "Seizure clusters can have a dramatic impact on a patient and caregiver's life. These data presented at AAN show that VALTOCO can help patients feel more confident about resuming their normal activity outside the home without concerns over privacy and ease-of-use they may have experienced in the past with rectally administered medication. In addition, the data shows that patients reported feeling like their usual self within two hours after VALTOCO administration. To be able to continue on with your day is very meaningful for patients with seizure clusters."

The details for the poster presentations are as follows and are available online to review here; posters can be searched by name. 

Abstract: 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

Abstract: 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: Exploring the Impact of Need for a Second Dose of Rescue Therapy for Seizure Episodes on Healthcare Utilization

Abstract: Evaluation of Diazepam Nasal Spray in Patients with Epilepsy Concomitantly Using Maintenance Benzodiazepines: Interim Analysis from a Phase 3, Long-term, Open-label Safety Study

Abstract: Examining the Patient Experience With Diazepam Nasal Spray for Seizure Clusters: Patient-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study

Dr. Rabinowicz said the latest scientific information on VALTOCO can be viewed at http://www.neurelismedicalaffairs.com.

About VALTOCO

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.

About Neurelis

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:

Indication

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.

Glaucoma

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.

Adverse Reactions

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.

For More Information:
Mark Leonard
mark@reachthenextlevel.com
858-251-2100

SOURCE Neurelis, Inc.