NEURELIS TO HIGHLIGHT VALTOCO (DIAZEPAM NASAL SPRAY) CIV DEVELOPMENT PROGRAM Updates AT 16TH EILAT CONFERENCE
- Company to provide an overview of studies and publications for VALTOCO® in treating episodes of frequent seizure activity (seizure clusters)
SAN DIEGO, CA ̶ May 31, 2022— Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO® (diazepam nasal spray), an acute therapy for episodes of frequent seizure activity (seizure clusters), at the 16th EILAT Conference on New Antiepileptic Drugs and Devices, Madrid Spain, May 22-25, 2022.
Sponsored by the International League Against Epilepsy, the EILAT conference is designed to provide an in-depth progress report on new antiepileptic drugs in various stages of development, as well as to present new findings on second-generation treatments. Sunita Misra, M.D., Neurelis Senior Medical Director, will summarize study findings and other updates on VALTOCO, a portable, ready-to-use therapy, since it was approved by the U.S. Food & Drug Administration (FDA) in January 2020 for acute treatment of seizure clusters in adults and pediatric patients ages 6 and above.
The VALTOCO development program included 175 patients and treated more than 4,000 seizures. Since its FDA approval, 69 posters have been presented at national and international scientific meetings, and 17 peer-reviewed publications have described safety and efficacy results. Currently, the Stellina™ trial, a Phase 1/2a open-label study of VALTOCO, is investigating pharmacokinetics, safety, and tolerability in pediatric epilepsy patients ages 2 to 5.
“Our clinical program broadly highlights what we in the epilepsy community consider a serious unmet need: the provision of safe, reliable, and more convenient therapies to people living with the challenges of seizure clusters,” said Enrique Carrazana, M.D., Neurelis Chief Medical Officer.
Oral Presentation Information
- Diazepam Nasal Spray (VALTOCO®): An Update Since Approval. Session 4: Innovative Routes of Administration; Tuesday, May 24, 16:00-16:30
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’s 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. 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 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). 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:
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.
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.
Brittany Bradrick, Chief Financial Officer, +1 858 251 2135
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