• Final results from long-term, open-label, repeat-dose Phase 3 study of VALTOCO® (diazepam nasal spray) for episodes of frequent seizure activity include findings on ease of dosing and quality of life
  • Investigational analysis on timing of a second dose of VALTOCO®

SAN DIEGO, April 4, 2022 / PRNewswire / – Neurelis, Inc., will present three posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (ie, seizure clusters) in patients with epilepsy ages 6 to 65 at the 73rd Annual Meeting of the American Academy of Neurology (AAN), April 2 is 7in Seattle, Wash. These presentations will highlight ease of use, quality of life, and timing of administration of VALTOCO. The full abstracts are available on the AAN meeting website.

VALTOCO, a nasal spray for acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the US Food and Drug Administration (FDA) on Jan. 10, 2020. The AAN posters report the following:

  • Analysis of factors supporting ease of use of diazepam nasal spray. Patient diary entries from the long-term safety study confirmed that treatment administration occurred after seizure onset within a median time of two minutes. The majority of caregivers and patients who self-administered the nasal spray reported that the therapy was either extremely or very easy to use.
  • Results from a patient-reported Quality of Life in Epilepsy (QOLIE) questionnaire among adults with episodes of frequent seizure activity participating in the long-term safety study of diazepam nasal spray. Findings indicated that QOLIE scores were maintained across the 12-month treatment period. Seizure worries and social functioning scores improved during the study.

Additional investigational analysis was done with the following AAN poster reporting:

  • The majority (87%) of treatments in the long-term study used only a single dose over 24 hours. In the instances where a second dose was administered, investigational analysis was performed on the timing of the dose. Second doses administered in less than four hours were not associated with more safety events than those administered after four hours in a clinical trial setting. (VALTOCO prescribing information indicates that a second dose may be given at least 4 hours after the first dose, if needed.)

“Episodes of frequent seizures are emergencies that are associated with an increased risk of progression to status epilepticus, more frequent emergency room visits, and disruption of the daily life and work of both patients and care partners,” said Enrique Carrazana, MD, Neurelis Chief Medical Officer. “These new abstracts, along with over 60 other presentations at national and international scientific meetings over the past years, add to the increasing clinical evidence of the safety and effectiveness of VALTOCO in treating this patient population.”

In granting VALTOCO Orphan Drug Exclusivity, the FDA recognized its intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (DIASTAT®a rectal gel formulation of diazepam).

Despite the availability of chronic, daily oral medications to help manage seizures, many of the 50 million epilepsy patients worldwide continue to experience recurring breakthrough seizures that, if left untreated, can cause damage to the brain.

“Our ultimate goal is to improve health outcomes for patients. Reaching this goal requires addressing gaps in seizure treatment and control,” stated Adrian Rabinowicz, MD, SVP Clinical Development and Medical Affairs. “Our aim is to help healthcare providers and patients develop self or care-partner solutions to stop these challenging episodes of frequent seizures as soon as they start. The availability of a rescue medication that is easy to use, convenient to carry, and socially acceptable for use in public may help patients and their care-partners choose to use rescue therapy instead of relying on hospitalization in the event of a seizure cluster emergency. “

The 12-month Phase 3 study, which evaluated the long-term safety of VALTOCO, included 175 subjects. Out of the total subjects enrolled, there were 163 patients that were dosed; 3,853 seizures were treated with at least one dose of VALTOCO.

Details of a selection of the poster presentations are below and available online to review at the American Academy of Neurology Annual Meeting website.

Additional investigational abstract:

About Neurelis

Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 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. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail’s 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 US 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 ). For more information on VALTOCO, please visit www.valtoco.com. In addition to VALTOCO, Neurelis 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. In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, pre-clinical stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit www.neurelis.com. For the latest scientific information on VALTOCO, please visit www.neurelismedicalaffairs.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.

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 is 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 Informationincluding Boxed Warning, for additional important safety information.

Contacts:

Neurelis:
Brittany BradrickChief Financial Officer, +1 858 251 2135

Media:
Erich SandovalFinn Partners, +1 917 497 2867

SOURCE Neurelis, Inc.

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