The Food and Drug Administration (FDA) has granted extended expiration dating for diazepam nasal spray (Valtoco; Neurelis, Inc., San Diego, CA). Diazepam was approved by the FDA on January 10, 2020, for the acute treatment of intermittent stereotypic episodes of frequent seizure activity that are distinct from an individual’s usual seizure pattern in people age 6 years and more. At the time of approval, the FDA also granted diazepam 7 years of orphan drug exclusivity. The FDA recognized diazepam's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment as part of the Orphan Drug Exclusivity designation.
"We are excited that the FDA has extended the diazepam product expiration to more than 2 years," said Craig Chambliss, the company's president and chief executive officer. "Seizure emergencies can happen at any time and any place. Patients, care partners, and healthcare providers need a reliable product that is available when and where they need it."
In a long-term open-label repeat-dose clinical trial, the safety of diazepam was evaluated and more than 4,000 seizures were treated. The clinical trial included adults and children age 6 and more. Diazepam 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.
Adam M. Staffaroni, PhD; Elena Tsoy, PhD; Jack Taylor, BS; Adam L. Boxer, MD, PhD; and Katherine L. Possin, PhD
Ajay Sood, MD, PhD, and David Bennett, MD
Ganesh M. Babulal, PhD, OTD, and Catherine M. Roe, PhD