Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO? (Diazepam Nasal Spray)

Partner News

20th Oct 2020 – Neurelis, Inc.issued an announcement, which is summarized as follows

Neurelis, Inc., announced today that the U.S.Food and Drug Administration (FDA) has granted extended expiration dating for the company’s lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the FDA on January 10, 2020, 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 adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO’s intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.

“We are excited that the FDA has extended the VALTOCO product expiration to more than two 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.”

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