PLC’s continued support of Neurelis in regulatory filings and clinical trial development, site management, data management for multiple successful trials and new product development results in approval and commercial availability of Valtoco®.
Neurelis Announces Commercial Availability- Valtoco® (Diazepam Nasal Spray) for Seizure Cluster Rescue
— VALTOCO is the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older
— Copay and patient assistance program to be provided by Neurelis for eligible VALTOCO patients
SAN DIEGO, CA – March 2, 2020 – Neurelis, Inc., announced today the commercial availability of VALTOCO® (diazepam nasal spray) 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.
Neurelis President and CEO Craig Chambliss said the company has been working diligently to deliver VALTOCO to the epilepsy community following the U.S. Food and Drug Administration (FDA) approval of VALTOCO on January 10, 2020, where it recognized VALTOCO’s intranasal route of administration as clinically superior to the previously approved standard of care treatment. “We understand the high unmet need for VALTOCO and we are very pleased to be able to make this available for patients with seizure clusters less than two months after our FDA approval,” Chambliss said. “Our commitment to the epilepsy community drives every team member at Neurelis as we accomplish this goal.”
In the United States, there are over 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Despite the availability of chronic, daily oral medications to control epilepsy, a significant number of these patients continue to experience seizures. Of these uncontrolled patients, as many as 170,000 are at risk for episodes of frequent seizure activity, also known as seizure clusters or acute repetitive seizures, representing a significant unmet need in the epilepsy community.
Chuck DeWildt, Chief Commercial Officer at Neurelis, announced Maxor Specialty Pharmacy has been selected as the national pharmacy provider and has already begun filling patient prescriptions. “VALTOCO is the first commercial product for Neurelis and we are now rapidly building our commercial organization,” DeWildt said. “Working with Maxor allows us to expedite the availability of VALTOCO for patients, healthcare providers and care partners who need it in advance of VALTOCO availability in retail pharmacies in the near future.” He added that Maxor will be able to serve all patients regardless of the type of insurance (commercial, private insurance, Medicaid or Medicare).
Michael Einodshofer, Chief Pharmacy Officer of Maxor, commented, “We look forward to our relationship with Neurelis and helping epilepsy patients across the country quickly gain access to this important new treatment.”
In an effort to support patients, Neurelis is offering a VALTOCO copay assistance program through which eligible patients could pay as little as $20 for the prescription. Neurelis has also set up a patient assistance program in which eligible patients who do not have insurance may qualify for additional assistance.
Jacqueline A. French, MD, professor in the Department of Neurology at NYU Langone Health’s Comprehensive Epilepsy Center and Chief Medical & Innovation Officer for the Epilepsy Foundation, said, “Having a seizure cluster rescue treatment that is generally safe, reliable and ready-to-use is great news for our epilepsy community. Seizure rescue treatments such as this, combined with an up-to-date seizure rescue treatment plan, can help improve the quality of life for those experiencing seizure clusters.”
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 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 Maxor
Maxor is transforming the pharmacy industry to create healthier lives through purposeful engagement across pharmacy benefit management, pharmacy management, specialty pharmacy, 340B, rebate and formulary management and pharmacies. The company puts people first and is committed to providing outstanding service across all aspects of its business. Maxor’s goal is to create innovative solutions to manage pharmacy costs and improve clinical outcomes. For more information on Maxor, please visit www.maxor.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 U.S. Food and Drug Administration (FDA) approved Neurelis’ 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. 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 psychomotor agitation (PMA) symptoms outside of the medical setting. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel™, three proprietary, noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules and small molecules. For more information on Neurelis, please visit www.neurelis.com.
Important Safety Information about VALTOCO:
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
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
RISK FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in 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
Contraindications: VALTOCO is contraindicated in patients with:
- Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.
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 see full Prescribing Information, including Boxed Warning, for additional important safety information.
