The drug was previously approved for the treatment of acute repetitive seizures and granted 7 years of orphan drug exclusivity in January 2020.
Jacqueline A. French, MD
Neurelis has announced that diazepam nasal spray (Valtoco), a medication approved for the treatment of acute, intermittent, stereotypic episodes of frequent seizure activity, otherwise known as seizure clusters, is now commercially available for prescription.
Chuck DeWildt, chief commercial officer, Neurelis, announced Maxor Speciality Pharmacy was selected as the national pharmacy provider and will continue to fill prescriptions going forth.
“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 2 months after our FDA approval,” Craig Chambliss, president and chief executive offer, Neurelis, said in a statement.
Diazepam has had a long history with its approval from the FDA. The drug was originally approved in January 2020 for the treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
Prior to that, researchers presented data at the 2019 American Epilepsy Society Meeting, December 6-10, 2019, that demonstrated the drug’s safe and tolerable profile, regardless of usage frequency. At the same conference, researchers unveiled that diazepam buccal film had a comparable bioavailability to rectal diazepam, the original model make of the drug.
Neurelis also announced it will be offering a diazepam copay assistance program, where eligible patients can pay as low as $20 for the prescription. Additionally, the company has set up a patient assistance program designed to qualify those who don’t have insurance for additional assistance.
"Having a seizure cluster rescue treatment that is generally safe, reliable and ready-to-use is great news for our epilepsy community,” Jacqueline A. French, MD, professor of neurology, NYU Langone Health Comprehensive Epilepsy Center, and chief medical and innovation officer, Epilepsy Foundation, said in a statement. “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."
Neurelis announces commercial availability of Valtoco (diazepam nasal spray) for seizure cluster rescue [news release]. San Diego, CA. Neurelis. March 2, 2020. Accessed March 2, 2020. prnewswire.com/news-releases/neurelis-announces-commercial-availability-of-valtoco-diazepam-nasal-spray-for-seizure-cluster-rescue-301014121.html.