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A Message to the Epilepsy Community from our President and CEO

A MESSAGE TO THE EPILEPSY COMMUNITY FROM OUR PRESIDENT AND CEO

In the midst of the uncertainty of the COVID-19 pandemic, it is important for us to be grounded in something bigger than ourselves. At Neurelis, our main focus is the well-being of our patients, healthcare providers, and employees. Our company was founded to solve the unmet needs in epilepsy that have persisted for far too long. We are more focused than ever on addressing those needs.

The health and wellness of the community is at the forefront of everything we do. With this in mind, we have taken steps to ensure that VALTOCO® (diazepam nasal spray) CIV and related information on managing seizure cluster emergencies will be available for anyone who needs it. We have created the appropriate back-up sites with our suppliers and distribution partners to ensure there will be no disruption to VALTOCO supply. As part of these efforts, Neurelis has chosen Maxor Specialty Pharmacy as our partner to fulfill prescriptions for VALTOCO. This approach means there is no need to go to a potentially congested retail pharmacy to have a prescription filled for VALTOCO. Once a prescription has been written and sent in by the healthcare provider to Maxor, VALTOCO gets delivered right to the patient’s doorstep for no additional cost by UPS – generally within 48 hours after insurance is submitted and processed.

Please be assured that, during these financially challenging times, Neurelis is also offering copay assistance and a patient assistance program for eligible patients. For more information on these programs and the materials available for patients and caregivers, please visit https://www.valtoco.com.

Please also know that the Neurelis team is at your disposal today and anytime in the future. If we can help in any way, please reach out and let us know. Our thoughts and prayers go out to everyone in the epilepsy community during this health crisis. We will get through these times together and be stronger as a result.

Very best regards,

Craig Chambliss

President and Chief Executive Officer

What is VALTOCO® (diazepam nasal spray)?

  • VALTOCO is a prescription medicine used for the short-term treatment of seizure clusters (also known as “episodes of frequent seizure activity” or “acute repetitive seizures”) in patients 6 years of age and older.
  • VALTOCO is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep VALTOCO in a safe place to prevent misuse and abuse. Selling or giving away VALTOCO may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.
  • It is not known if VALTOCO is safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VALTOCO?

  • VALTOCO is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
    • Shallow or slowed breathing
    • Breathing stops (which may lead to the heart stopping)
    • Excessive sleepiness (sedation)
  • Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including VALTOCO, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in VALTOCO). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • Use VALTOCO exactly as your healthcare provider prescribed.
  • Physical dependence and withdrawal reactions. Benzodiazepines, including VALTOCO, can cause physical dependence and withdrawal reactions, especially if you use VALTOCO daily. VALTOCO is not intended for daily use.
  • VALTOCO can make you sleepy or dizzy and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
    • Do not drink alcohol or take opioid medicines that make you sleepy or dizzy while taking VALTOCO until you talk to your healthcare provider. When taken with alcohol or medicines that can cause sleepiness or dizziness, VALTOCO may make your sleepiness or dizziness worse.
  • Like other antiepileptic drugs, VALTOCO may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any new or worsening suicidal thoughts or related symptoms, especially unusual changes in mood, behaviors, thoughts or feelings.

How can I watch for early symptoms of suicidal thoughts or actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not use VALTOCO if you:

  • Are allergic to diazepam.
  • Have an eye problem called acute narrow-angle glaucoma.

What should I tell my doctor before taking VALTOCO?

Before using VALTOCO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
  • Have a history of alcohol or drug abuse.
  • Have a history of depression, mood problems, or suicidal thoughts or behavior.
  • Have liver or kidney problems.
  • Are pregnant or plan to become pregnant. VALTOCO may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. VALTOCO passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use VALTOCO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use VALTOCO?

  • Read the Instructions for Use for detailed information about the right way to use VALTOCO.
  • Use VALTOCO exactly as prescribed by the healthcare provider.
  • Your healthcare provider will tell you:
    • What seizure clusters are
    • Exactly how much VALTOCO to give
    • When and how to give VALTOCO
    • What to do after you give VALTOCO if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you
  • You should carry VALTOCO with you in case you need to control your seizure clusters.
  • VALTOCO is given in the nose (nasal) only.
  • Each VALTOCO only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
  • Each dose of VALTOCO is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

What should I do after I give VALTOCO?

  • Stay with the person after you give VALTOCO and watch them closely.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
    • Seizure cluster behavior is different than other seizure clusters the person has had.
    • You are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.
  • Throw away (discard) the used VALTOCO.

If needed, a second dose may be given at least 4 hours after the first dose, using a new pack of VALTOCO. Do not give more than 2 doses of VALTOCO to treat a seizure cluster.

A second dose should not be given if there is concern about the person's breathing, they need help with their breathing, or have extreme drowsiness.

Do not use VALTOCO for more than 1 seizure cluster episode every 5 days. Do not use VALTOCO for more than 5 seizure cluster episodes in 1 month.

What are the most common side effects of VALTOCO?

The most common side effects of VALTOCO include:

  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort

These are not all of the possible side effects of VALTOCO. Call your healthcare provider for medical advice about side effects. You may report side effects to Neurelis, Inc. at 1-866-696-3873 or to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for additional important safety information.

 

 

References: 1. VALTOCO® (diazepam nasal spray) Prescribing Information. Neurelis, Inc. 2. Jafarpour S, Hirsch LJ, Gainza-Lein M, Kellinghaus C, Detyniecki K. Seizure cluster: definition, prevalence, consequences, and management. Seizure. 2019;68:9-15. 3. Tian N, Boring M, Kobau R, Zack MM, Croft JB. Active epilepsy and seizure control in adults—United States, 2013 and 2015. MMWR Morb Mortal Wkly Rep. 2018;67(15):437-442. 4. National Institute of Neurological Disorders and Stroke. The epilepsies and seizures: hope through research. NIH publication 15-156. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Epilepsies-and-Seizures-Hope-Through. Published April 2015. Updated August 8, 2018. Accessed January 24, 2019. 5. Manford M. Recent advances in epilepsy. J Neurol. 2017;264:1811-1824. 6. Fisher RS, Bartfeld E, Cramer JA. Use of an online epilepsy diary to characterize repetitive seizures. Epilepsy Behav. 2015;47:66-71. 7. Epilepsy Foundation Greater Chicago. Status Epilepticus. https://www.epilepsychicago.org/epilepsy/seizure-types/status-epilepticus/. Accessed July 9, 2019. 8. Manno EM. Status epilepticus: current treatment strategies. Neurohospitalist. 2011;1(1):23-31. 9. Epilepsy Innovation Institute. Epilepsy Innovation Institute (Ei2): 2016 Community Survey [online] 2017;1–6. http://www.epilepsy.com/sites/core/files/atoms/files/community-survey-report-2016%20V2.pdf. Accessed July 3, 2019. 10. Schulze-Bonhage A, Kuhn A. Unpredictability of seizures and the burden of epilepsy. In: Schelter B, Timmer J, Schulze-Bonhage A, eds. Seizure Prediction in Epilepsy. Wiley-VCH Verlag GmbH & Co. KGaA; 2008. 11. Sander JW. Ultimate success in epilepsy—the patient’s perspective. Eur J Neurol. 2005;12(Suppl 4):3-11. 12. Bonnett LJ, Powell GA, Smith CT, Marson AG. Breakthrough seizures—further analysis of the standard versus new antiepileptic drugs (SANAD) study. PLoS One. 2017;12(12):e0190035. 13. Maglalang PD, Rautiola D, Siegel RA, et al. Rescue therapies for seizure emergencies: new modes of administration. Epilepsia. 2018;59(Suppl 2):207–215. 14. Agarwal SK, Kriel RK, Brundage RC, Ivaturi VD, Cloyd JC. A pilot study assessing the bioavailability and pharmacokinetics of diazepam after intranasal and intravenous administration in healthy volunteers. Epilepsy Res. 2013;105:362-367. 15. Parsonage MJ, Norris JW. Use of diazepam in treatment of severe status epilepticus. Br Med J. 1967;3:85-88. 16. Maggio ET. Intravail: highly effective intranasal delivery of peptide and protein drugs. Expert Opin Drug Deliv. 2006;3(4):529-539. 17. Data on file: VALTOCO Clinical Study Report DIAZ.001.05-CSR. Neurelis, Inc.

 

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING 

What is the most important information I should know about VALTOCO?

  • VALTOCO is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
    • Shallow or slowed breathing
    • Breathing stops (which may lead to the heart stopping)
    • Excessive sleepiness (sedation)
  • Risk of abuse, misuse, and addiction. There is a risk for abuse, misuse, and addiction with benzodiazepines, including VALTOCO, which can lead to overdose and serious side effects including coma and death.
    • Serious side effects have happened in people who have abused or misused benzodiazepines, including diazepam (the active ingredient in VALTOCO). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
    • Use VALTOCO exactly as your healthcare provider prescribed.
  • Physical dependence and withdrawal reactions. Benzodiazepines, including VALTOCO, can cause physical dependence and withdrawal reactions, especially if you use VALTOCO daily. VALTOCO is not intended for daily use.
  • VALTOCO can make you sleepy or dizzy and can slow your thinking and motor skills.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
    • Do not drink alcohol or take opioid medicines that make you sleepy or dizzy while taking VALTOCO until you talk to your healthcare provider. When taken with alcohol or medicines that can cause sleepiness or dizziness, VALTOCO may make your sleepiness or dizziness worse.
  • Like other antiepileptic drugs, VALTOCO may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any new or worsening suicidal thoughts or related symptoms, especially unusual changes in mood, behaviors, thoughts or feelings.

How can I watch for early symptoms of suicidal thoughts or actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Do not use VALTOCO if you:

  • Are allergic to diazepam.
  • Have an eye problem called acute narrow-angle glaucoma.

What should I tell my doctor before taking VALTOCO?

Before using VALTOCO, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
  • Have a history of alcohol or drug abuse.
  • Have a history of depression, mood problems, or suicidal thoughts or behavior.
  • Have liver or kidney problems.
  • Are pregnant or plan to become pregnant. VALTOCO may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. VALTOCO passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use VALTOCO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use VALTOCO?

  • Read the Instructions for Use for detailed information about the right way to use VALTOCO.
  • Use VALTOCO exactly as prescribed by the healthcare provider.
  • Your healthcare provider will tell you:
    • What seizure clusters are
    • Exactly how much VALTOCO to give
    • When and how to give VALTOCO
    • What to do after you give VALTOCO if the seizures do not stop or there is a change in breathing, behavior, or condition that worries you
  • You should carry VALTOCO with you in case you need to control your seizure clusters.
  • VALTOCO is given in the nose (nasal) only.
  • Each VALTOCO only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
  • Each dose of VALTOCO is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.

What should I do after I give VALTOCO?

  • Stay with the person after you give VALTOCO and watch them closely.
  • Make a note of the time VALTOCO was given.
  • Call for emergency help if any of the following happen:
    • Seizure cluster behavior is different than other seizure clusters the person has had.
    • You are alarmed by how often the seizures happen, by how severe the seizure is, by how long the seizure lasts, or by the color or breathing of the person.
  • Throw away (discard) the used VALTOCO.

If needed, a second dose may be given at least 4 hours after the first dose, using a new pack of VALTOCO. Do not give more than 2 doses of VALTOCO to treat a seizure cluster.

A second dose should not be given if there is concern about the person's breathing, they need help with their breathing, or have extreme drowsiness.

Do not use VALTOCO for more than 1 seizure cluster episode every 5 days. Do not use VALTOCO for more than 5 seizure cluster episodes in 1 month.

What are the most common side effects of VALTOCO?

The most common side effects of VALTOCO include:

  • Feeling sleepy or drowsy
  • Headache
  • Nose discomfort

These are not all of the possible side effects of VALTOCO. Call your healthcare provider for medical advice about side effects. You may report side effects to Neurelis, Inc. at 1-866-696-3873 or to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for additional important safety information.