Meet Craig Chambliss, CEO and Co-Founder of Neurelis, Inc. It has been a big year in rescue medications thanks to decades of work by Chambliss and his team. In January 2020 Neurelis learned their product, VALTOCO, a diazepam nasal spray, was approved by the FDA, and in March of 2020 they announced it was commercially available.
Craig will join me today, April 15, at 3pm ET as my guest on Instagram Live. We will chat about the importance of rescue medications now and moving forward.
A message to the epilepsy community from Craig Chambliss
In the midst of the uncertainty of the COVID-19 pandemic it is important for us to be grounded in something bigger than ourselves. We see it in everything you do for the epilepsy community and we are thankful to be a part of this journey. Neurelis 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 at Neurelis. It truly is our passion and, during this time of uncertainty, I want to assure you that Neurelis is doing everything we can to ensure patients have access to necessary rescue medication.
We will continue to do our part both now and in the calmer waters of the future. 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 is utilizing Maxor 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 http://www.valtoco.com. Also see the Important Safety Information for VALTOCO at the end of this note.
Please know that the Neurelis team is at your disposal. Your efforts have always been a tremendous source of inspiration for me. From my earliest conversations with the amazing doctors, nurses and advocacy staff almost two decades ago, I was irreversibly impressed with the passion and dedication shown in managing the challenges of epilepsy. There was a level of compassion and engagement with patients and caregivers that I had not seen previously. It was truly compelling. It has carried us through the early days of advocating for seizure rescue plans with the backdrop of 9/11/2001 and challenges in development funding in the economic downturn of 2008/09. It will carry us through this, as well.
It is my prayer that this pandemic will bring us closer as a community. It is a time of reflection and it gives me this chance to personally tell you how important your work is, how important and blessed we are to be working with you, and that you can count on us for support.
Finally, I want to thank you for supporting us. It’s been an incredible journey to bring VALTOCO to the epilepsy community and your support of our efforts means more to me than you can ever imagine. We will get through these times together and be stronger as a result.
My hope is that this note finds you, your loved ones, colleagues, and community at-large in good health and spirits.
What is VALTOCO® (diazepam nasal spray)?
- VALTOCO is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 6 years of age and older.
- VALTOCO is a federal 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 you should know about VALTOCO® (diazepam nasal spray), CIV
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 depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
- VALTOCO can make you sleepy or dizzy and can slow your thinking and your motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how VALTOCO affects you.
- 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 of these symptoms, especially if they are new, worse, or worry you:
|• Thoughts about suicide or dying||• Trouble sleeping (insomnia)|
|• Feeling agitated or restless||• An extreme increase in activity and talking (mania)|
|• Acting aggressive, being angry, or violent||• New or worse anxiety|
|• Attempts to commit suicide||• New or worse irritability|
|• Panic attacks||• Other unusual changes in behavior or mood|
|• Acting on dangerous impulses||• New or worse depression|
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:
o What seizure clusters are
o Exactly how much VALTOCO to give
o When to give VALTOCO
o How to give VALTOCO
o 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.
- Family members, care providers, and other people who may have to give VALTOCO should know where you keep your VALTOCO and how to give VALTOCO before a seizure cluster happens.
- VALTOCO is given in the nose (nasal) only.
- VALTOCO comes ready to use.
- 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.
- Keep or move the person onto their side.
- Make a note of the time VALTOCO was given.
- Call for emergency help if any of the following happen:
o Seizure behavior is different than other seizures the person has had.
o 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 should I avoid while using VALTOCO?
- 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.
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.