NEURELIS PRESENTED CLINICAL DATA IN SUPPORT OF SEIZURE CLUSTER INTERVAL ANALYSIS AT THE EPILEPSY FOUNDATION PIPELINE CONFERENCE

  • Results of post-hoc analysis of Phase 3 clinical trial data may support previously unrecognized effect of intermittent rescue therapy

SAN DIEGO, June 7, 2022 /PRNewswire/ — Neurelis, Inc., has announced the results of a new experimental analysis of VALTOCO® (diazepam nasal spray) CIV. The data indicates that patients using the therapy had a statistically and clinically significant increase in the time between their seizure clusters, or SEIzure cluster interVAL (SEIVAL) over a 12-month period. VALTOCO, a nasal spray for the acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the United States Food and Drug Administration (FDA) in 2020. These experimental data were presented at the Epilepsy Foundation Pipeline Conference, held in person and virtually June 5-6, 2022.

“VALTOCO and other salvage therapies play an essential role in treatment plans for people with poorly controlled epilepsy and epileptic clusters,” said Sunita Misra, MD, Ph.D., Neurelis Senior Medical Director. “Analysis of Phase 3 clinical trial data demonstrates that the increase in SEIVAL reflects a clinically meaningful increase in intervals between seizure clusters over time.”

Sponsored by the Epilepsy Foundation, the Pipeline Conference provides an exciting forum for scientific contributors to talk about the latest advances in epilepsy treatment and demonstrated innovation in clinical research. The VALTOCO Phase 3 program has enrolled 175 patients and treated more than 4,000 attacks. Dr. Misra summarized the new SEIVAL experimental analysis for understanding seizure cluster patterns by looking at the time between doses.

Key findings from this analysis include:

  • For patients in the initial SEIVAL sensitivity analysis, the mean SEIVAL increased clinically and statistically for days 271 to 360 compared to days 1 to 90 (P
  • The diary data suggests that administration of VALTOCO within the first five minutes of seizure onset reduced the time to seizure cessation, total seizure duration.

Information on the oral presentation

  • New hypothesis-generating analysis of intervals between crisis clusters; June 6, 4:50-5:00 PM PT

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 neurological disorders characterized by high unmet medical need. In 2020, the FDA approved VALTOCO from Neurelis® (diazepam nasal spray) as an acute treatment for stereotypical intermittent episodes of frequent seizure activity (i.e., cluster seizures, repetitive acute seizures) distinct from an individual’s usual seizure pattern in adult and pediatric patients of 6 years and over. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail’s transmucosal absorption enhancement technology enables non-invasive delivery of a wide range of proteins, peptides and small molecule drugs. In its approval of VALTOCO, the United States 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 treatment. previously approved standard (a rectal gel formulation of diazepam). For more information about 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 an acute noninvasive therapy to arrest seizures that have progressed to status epilepticus, and NRL-4 as Noninvasive rescue therapy to treat the escalation of acute agitation symptoms associated with schizophrenia and bipolar mania 1 in adults. In addition, Neurelis is developing NRL-1049 (formerly known as BA-1049), an investigational preclinical small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a disorder rare central nervous system (CNS). For more information about 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, stereotypical episodes of frequent seizure activity (i.e., cluster seizures, repetitive acute seizures) distinct from the usual seizure pattern in patients with epilepsy aged 6 years and older.

WARNING: RISKS FROM CONCOMITANT OPIOID USE; ABUSE, MISUSE AND DEPENDENCE; and ADDICTION AND WITHDRAWAL REACTIONS

  • Concomitant use of benzodiazepines and opioids can lead to profound sedation, respiratory depression, coma and death. Restrict the concomitant prescription of these drugs to patients for whom therapeutic alternatives are insufficient. Limit dosages and times to the minimum required. Monitor patients for signs and symptoms of respiratory depression and sedation.
  • Use of benzodiazepines, including VALTOCO, puts users at risk of abuse, misuse, and dependence, which can lead to overdose or death. Abuse and misuse of benzodiazepines usually involves the concurrent use of other drugs, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse effects. Before prescribing VALTOCO and throughout treatment, assess each patient’s risk of abuse, misuse and dependence.
  • Continued use of benzodiazepines can lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with a longer duration of treatment and a higher daily dose. Although VALTOCO is only indicated for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid reduction in dosage of VALTOCO may trigger acute, potentially life-threatening withdrawal reactions. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a taper to stop VALTOCO.

Contraindications: VALTOCO is contraindicated in patients with:

  • 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 drug effects, 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 ideation and behavior. Patients treated with any AED for any indication should be monitored for new or worsening depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

Glaucoma

Benzodiazepines, including VALTOCO, may increase intraocular pressure in patients with glaucoma. VALTOCO can only be used in patients with open-angle glaucoma if they receive appropriate treatment. VALTOCO is contraindicated in patients with angle-closure glaucoma.

Risk of serious adverse effects in infants due to preservative benzyl alcohol

VALTOCO is not approved for use in newborns or infants. Serious and fatal side effects, including “gasping syndrome”, can occur in neonates and low birth weight infants treated with medicines containing benzyl alcohol, including VALTOCO. “Gapping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping breathing. The minimum amount of benzyl alcohol at which serious side effects can occur is not known.

Side effects

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 ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read completely Prescribing Informationincluding boxed warning, for additional important safety information.

contacts:

Neurelis:
Brittany BradrickCFO, +1 858 251 2135

Media:
Erich SandovalFinn Partners, +1 917 497 2867

SOURCENeurelis, Inc.

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