On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of cluster seizures in epilepsy.
Aquestive, which is developing a diazepam buccal oral film for the treatment of breakthrough seizures, says the agency should require a bridging study to compare Valtoco to Diastat diazepam rectal gel on the grounds that “The existing clinical studies for Valtoco demonstrate considerable pharmacokinetic (“PK”) variability and do not support the development of robust and adequate labeling for the product.”
According to the citizen petition, Valtoco’s “curiously-delayed Tmax” suggests that the drug is being swallowed instead of being absorbed through the nasal mucosa. Valtoco’s formulation is based on Intravail transmucosal absorption technology, which Neurelis acquired when it acquired Aegis Therapeutics.
Aquestive also resquested a food effects study and that “unless the additional clinical studies demonstrate otherwise, the U.S. Food and Drug Administration (FDA) must determine Valtoco does not offer a major contribution to patient care under the Orphan Drug Act.”
Read the Aquestive Therapeutics citizen petition.
