Drugs

Require Nasal Spray Food Studies: Aquestive

Aquestive Therapeutics has petitioned FDA to not approve any application for a nasal spray drug product that omits studies characterizing food effects if the active moiety, when separately approved for oral use, has demonstrated a food effect. The 7/29 petition specifically asks that the agency:

refuse to approve any nasal spray without food effect studies where the active moiety has demonstrated a food effect when administered orally; and
investigate the lack of efficacy for such FDA-approved nasal sprays documented in FDA’s Adverse Event Reporting System.

The petition says Aquestive holds a 505(b)(2) NDA for Libervant (diazepam) and was required to submit food effect studies as part of its NDA. However, it says, Neurelis’ Valtoco (diazepam), an intra-nasally administered product, has an approved 505(b)(2) NDA without the need for food effect studies due to the low volume of product administered and presumably swallowed.

Aquestive says the agency denied its earlier 11/2019 petition asking for a Valtoco food effect study. It says FDA said that such studies are for orally-administered products only unless there is reason to believe that a proportion of the drug product will be swallowed and thus subject to a food effect and first-pass metabolism.

“Literature consistently shows that intranasal products are swallowed and thus are administered, to some degree, orally,” Aquestive contends. “As a result, it is important to understand the effect of food on these products, particularly because FAERS data reflect a lack of therapeutic effect for some nasal sprays. Where, like in the case of diazepam, therapeutic effect is in question and a food effect is known, FDA has an obligation to the public to investigate whether that lack of therapeutic effect is related to food effect.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome