ARS Prescribed drugs, the corporate behind neffy — the needle-free epinephrine nasal spray various to conventional auto-injectors — introduced at the moment they’d offered the FDA with all the extra data the company requested with a purpose to approve the product to be used within the US.
Mentioned Richard Lowenthal, Co-Founder, President and CEO of ARS:
Based mostly on a number of conferences with the FDA, we consider that we’ve got responded absolutely and fully to the Company’s issues and admire its insights alongside the way in which. Our concentrate on addressing any requests from the FDA to optimize our labeling stays important in our mission to deliver neffy to sufferers, suppliers, and caregivers who proceed to point out substantial enthusiasm for a needle-free, secure, efficient, and simple to hold epinephrine resolution. We sit up for working with the FDA in our efforts to make neffy obtainable to allergy sufferers as quickly as doable.
Though an FDA advisory panel overwhelmingly supported approval to be used in adults and kids final Could, the company requested further research which have now been accomplished and submitted.
The FDA now has a six-month interval to overview the info, however since a lot of the info was already reviewed final yr, the company ought to be capable of act a lot sooner.
Right here follows ARS Pharma’s press launch in it’s entirety.
April 03, 2024 09:01 ET| Supply: ARS Prescribed drugs, Inc.
Response addresses all further requests in FDA CRL, together with constructive knowledge from a repeat dose PK/PD research of neffy below nasal allergen problem (NAC) situations, and up to date testing that detected no measurable nitrosamine ranges, performed per August 2023 FDA Steerage
Submission of CRL response triggers as much as six-month overview interval by the FDA
SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) — ARS Prescribed drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to higher shield sufferers from extreme allergic reactions that might result in anaphylaxis, introduced at the moment that it has submitted its response to the U.S. Meals and Drug Administration (FDA) for its New Drug Software (NDA) for neffy® (epinephrine nasal spray), for the therapy of Kind I allergic reactions together with anaphylaxis.
The submission follows receipt of a Full Response Letter (CRL) from the FDA in September 2023, which recognized two further requests: completion of a repeat dose pharmacokinetic (PK) / pharmacodynamic (PD) research of neffy below nasal allergen problem (NAC) situations, and completion of up to date nitrosamine testing per the FDA’s draft steerage issued in August 2023.
In February 2024, ARS Pharma introduced the profitable completion of the repeat dosing research of neffy in seasonal allergic rhinitis below NAC situations. ARS Pharma additionally accomplished the nitrosamine testing requested with no measurable ranges of nitrosamines detected.
“After roughly six months of receiving the CRL for neffy, we had been in a position to pivot shortly to efficiently full the repeat dosing nasal allergen problem research and up to date nitrosamine testing with no measurable ranges of nitrosamines detected, and submit our response to the CRL,” stated Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “Based mostly on a number of conferences with the FDA, we consider that we’ve got responded absolutely and fully to the Company’s issues and admire its insights alongside the way in which. Our concentrate on addressing any requests from the FDA to optimize our labeling stays important in our mission to deliver neffy to sufferers, suppliers, and caregivers who proceed to point out substantial enthusiasm for a needle-free, secure, efficient, and simple to hold epinephrine resolution. We sit up for working with the FDA in our efforts to make neffy obtainable to allergy sufferers as quickly as doable.”
The unique neffy NDA was submitted in August 2022. In Could 2023, the FDA Advisory Committee (PADAC) decided a positive benefit-risk profile for neffy (16:6 for adults and 17:5 for kids). No PADAC member requested a repeat dose research throughout allergen-induced allergic rhinitis.
ARS Pharma anticipates an FDA overview interval of as much as six months, and the PDUFA date is anticipated to be October 2, 2024, based mostly on the submission receipt date of April 2, 2024.
About Kind I Allergic Reactions together with Anaphylaxis
Kind I extreme allergic reactions are critical and probably life-threatening occasions that may happen inside minutes of publicity to an allergen and require instant therapy with epinephrine, the one FDA-approved treatment for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are effectively revealed limitations that lead to many sufferers and caregivers delaying or not administering therapy in an emergency state of affairs. These limitations embrace concern of the needle, lack of portability, needle-related security issues, lack of reliability, and complexity of the units. There are roughly 40 million individuals in america who expertise Kind I extreme allergic reactions. Of these, solely 3.2 million had an energetic epinephrine autoinjector prescription in 2023, and of these, solely half constantly carry their prescribed autoinjector. Even when sufferers or caregivers carry an autoinjector, greater than half both delay or don’t administer the system when wanted in an emergency.
Ahead-Trying Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” inside the that means of the Non-public Securities Litigation Reform Act of 1995. These statements embrace, however should not restricted: the anticipated FDA overview interval; the anticipated FDA motion date and launch of neffy, if authorized; the idea that ARS Pharma has absolutely and fully responded to the FDA’s issues; and different statements that aren’t historic truth. As a result of such statements are topic to dangers and uncertainties, precise outcomes might differ materially from these expressed or implied by such forward-looking statements. Phrases similar to “anticipate,” “believes,” “potential,” “will,” and comparable expressions are meant to determine forward-looking statements. These forward-looking statements are based mostly upon ARS Pharma’s present expectations and contain assumptions which will by no means materialize or might show to be incorrect. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, which embrace, with out limitation, the flexibility to acquire and keep regulatory approval for neffy; regardless that the FDA has acknowledged that completion of the repeat-dose research below allergen-induced allergic rhinitis situations for neffy will sufficiently tackle the company’s excellent questions, there is no such thing as a assure that new points is not going to be recognized which might delay or stop the approval of neffy; whether or not the FDA will view the outcomes from ARS Pharma’s repeat dose research below allergen induced allergic rhinitis situations for neffy as profitable and adequate to help approval; the PDUFA goal motion date could also be additional delayed as a consequence of varied components exterior ARS Pharma’s management; potential security and different issues from neffy; the labelling for neffy, if authorized; the scope, progress and enlargement of creating and commercializing neffy; the dimensions and development of the market therefor and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; ARS Pharma’s capability to guard its mental property place; uncertainties associated to capital necessities; and the influence of presidency legal guidelines and laws. Extra dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included below the caption “Threat Components” in ARS Pharma’s Annual Report on Kind 10-Ok for the yr ended December 31, 2023, filed with the Securities and Change Fee (SEC) on March 21, 2024. This and different paperwork ARS Pharma information with the SEC can be accessed on ARS Pharma’s web site at ir.ars-pharma.com by clicking on the hyperlink “Financials & Filings” below the “Traders & Media” tab.
ARS Media Contact:
Laura O’Neill
Laura.oneill@finnpartners.com
ARS Investor Contact:
Justin Chakma
ARS Prescribed drugs
justinc@ars-pharma.com
