An ARS Prescribed drugs nasal spray anticipated to turn out to be the primary authorised non-injectable model of epinephrine for treating extreme allergic reactions has been turned down by the FDA, a call that bucks an affirmative advisory committee vote earlier this yr.
San Diego-based ARS Pharma characterised the rejection as a shock. Along with the advisory committee support, the corporate’s discussions with the FDA had gotten so far as product labeling and post-marketing necessities—steps which might be indications a product is on its strategy to an approval. In its late-Tuesday announcement of the destructive regulatory choice, ARS Pharma mentioned the company is now asking for extra information from one other research. The corporate mentioned it can attraction.
Epinephrine administered through intramuscular injection has obtainable relationship again to the 1987 FDA approval of EpiPen for treating sort 1 allergic reactions, that are quick reactions prompted by antigens from meals, remedy, or insect bites. Such reactions embrace anaphylaxis, which might be life-threatening. Self-injection pens present a strategy to instantly counteract these allergic reactions. ARS Pharma developed its intranasal product, dubbed Neffy, as one other approach to offer a fast response.
ARS Pharma’s product candidate consists of an aqueous formulation of epinephrine together with Intravail, an ingredient that improves how a lot of a drug is offered to offer its impact when it’s administered intranasally. Intravail is already a element of different FDA-approved intranasal merchandise. The system that administers the ARS Pharma product can also be a part of FDA-approved intranasal merchandise, maybe most notably the naloxone nasal spray Narcan.
ARS Pharma’s FDA submission included information from “human issue” research, that are assessments to make sure that how folks work together with a drug/system mixture product helps the security and efficacy of its meant use. In response to FDA documents, ARS included two human issue research as a part of its submission. In these research, members had been positioned in a simulated emergency state of affairs of responding to a extreme allergic response to themselves or another person.
The information from the human issue research had been adequate to assist the product’s new drug utility. In response to the corporate, its subsequent discussions with FDA led to alignment on a post-marketing research that will take a look at repeat doses of the product beneath allergen-induced allergic rhinitis circumstances. Full response letters will not be public paperwork, however ARS mentioned the FDA is now requiring that this repeat-dose research be a part of the appliance. That request comes regardless of the FDA advisory committee’s suggestion for approval with none extra assessments to point out security or efficacy.
“We’re very stunned by this motion and the late requirement right now to vary the repeat-dose research from a post-marketing requirement, which we had beforehand aligned on with FDA, to a pre-approval requirement, significantly given the constructive advisory committee vote,” ARS Pharma President and CEO Richard Lowenthal mentioned in a ready assertion. “The truth is, a number of committee members highlighted the favorable profile of Neffy in our accomplished single-dose nasal allergy problem research and that any decline in publicity 20 minutes after dosing, after the anticipated response interval, is of no concern.”
ARS Pharma is ready to conduct the extra research as a result of it had already agreed to it as a part of the post-marketing requirement. The corporate mentioned it expects to resubmit Neffy’s utility within the first half of subsequent yr, doubtlessly receiving an FDA choice within the second half of 2024. However traders confirmed their very own destructive response to the developments, and ARS Pharma’s inventory worth tumbled greater than 56% to $2.88 on Tuesday. The corporate, which has no income from any FDA-approved, had a money place of $117.9 million as of the tip of June, in keeping with its most up-to-date monetary report.
The ARS Pharma drug continues to be beneath evaluation by the European Medicines Company. The corporate plans submissions subsequent yr in different markets as properly.
Photograph: Getty Photos, Sarah Silbiger