Neurelis announced that the FDA has approved the use of Valtoco diazepam nasal spray for the treatment of seizure clusters in children aged 2 years of age and older. The FDA approved Valtoco for use in patients 6 years old and older in January 2020, and the company initiated a Phase 1/2a trial of Valtoco in epilepsy patients aged 2-5 the next year.
According to a December 18, 2024 FDA letter to Neurelis, the agency tentatively approved an sNDA that had been submitted in December 2023 to add the new patient population. However, the FDA said at the time, “Aquestive Therapeutics Inc.’s product, Libervant (diazepam) buccal film, has orphan-drug exclusivity, which blocks final approval of NDA 211635/S-010 for Valtoco (diazepam) nasal spray until Libervant’s orphan-drug exclusivity expires on April 26, 2031.” The next day, December 19, 2024, Aquestive announced that it had received orphan drug exclusivity for Libervant for the 2-5 year old population.
Valtoco had been granted orphan drug designation in December 2015; however, the FDA approved Libervant during Valtoco’s exclusivity period citing its safety for the 2-5 year-old population. Following the temporary approval of the Neurelis sNDA and the grant of exclusivity to Aquestive, Neurelis filed suit, and in February 2025, a judge for the US District Court of the District of Columbia ordered the FDA to withdraw its approval of Libervant.
Neurelis CEO Craig Chambliss commented, “We are so grateful for all those who participated in the clinical study to enable Valtoco to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures.”
Read the Neurelis press release
