- Firm aligned with FDA in August 2023 on each doctor labeling and post-market necessities, which included a repeat-dose research of neffy underneath allergen-induced allergic rhinitis situations
- FDA Advisory Committee (PADAC), held in Might 2023, beneficial neffy approval primarily based on present information set and with out recommending further trials
- FDA now requests repeat-dose research be accomplished previous to neffy approval versus beforehand agreed-upon post-marketing requirement
- Properly-capitalized with anticipated money, money equivalents and short-term investments readily available of roughly $195 million on the time of our anticipated neffy launch, if authorized in 2H24, following our resubmission to the FDA in 1H24
SAN DIEGO, Sept. 19, 2023 (GLOBE NEWSWIRE) — ARS Prescription drugs, Inc. (Nasdaq: SPRY), a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to raised defend sufferers from extreme allergic reactions that might result in anaphylaxis, right now introduced that the U.S. Meals and Drug Administration (FDA) issued a Full Response Letter (CRL) concerning its New Drug Utility (NDA) for neffy® (epinephrine nasal spray) within the therapy of Allergic Reactions (Kind I), together with anaphylaxis for adults and youngsters ≥30 kg. ARS Pharma plans to submit a Formal Dispute Decision Request (FDRR) to enchantment the issuance of this CRL.
Within the letter, the FDA requested completion of a pharmacokinetic/pharmacodynamic research assessing repeat doses of neffy in comparison with repeat doses of an epinephrine injection product underneath allergen-induced allergic rhinitis situations to assist approval. This request comes after the advice of the FDA Advisory Committee (PADAC) in Might 2023 to approve neffy with out the necessity for extra research to reveal its efficacy or security. Additional, FDA and ARS Pharma beforehand aligned in August 2023 on ultimate doctor’s labeling and a post-marketing requirement to conduct this research as informative for labeling.
The PADAC assembly was held on Might 11, 2023, and concluded a good benefit-risk profile of neffy, with a 16:6 vote in favor for adults and 17:5 vote in favor for kids (≥30 kg) for the therapy of sufferers with allergic reactions (Kind I), together with anaphylaxis. In that session, no member of the Committee raised particular issues about the results of the finished research in individuals with allergen-induced acute rhinitis with single-dose neffy, which confirmed enhanced absorption through the time interval when a medical response can be anticipated.
“We’re very shocked by this motion and the late requirement at the moment to alter the repeat-dose research from a post-marketing requirement, which we had beforehand aligned on with FDA, to a pre-approval requirement, notably given the constructive Advisory Committee vote. Actually, 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,” mentioned Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “We stand by the totality of the neffy information bundle generated in a complete registration program that was aligned upon with FDA and consider strongly within the worth neffy can present for sufferers, households and caregivers residing each day with extreme allergic reactions.”
Mr. Lowenthal continued, “If authorized, neffy would signify the first-ever needle-free nasal spray epinephrine therapy for individuals with extreme allergic reactions that has been proven to be extra simply carried and administered, with out nervousness or hesitation, which is vital to stopping illness development. Now we have heard an incredible outpouring of assist from the affected person, advocacy, and doctor communities, who’ve a vital want for a needle-free epinephrine therapy. We’re deeply disenchanted that this motion additional delays the provision of neffy for the tens of millions of people who find themselves susceptible to a doubtlessly life-threatening extreme allergic response. Sufferers and caregivers are ready for neffy, and we goal to finish the newly requested trial as rapidly as potential to fulfill the wants of sufferers.”
As ARS Pharma beforehand agreed with FDA to conduct a repeat-dose research underneath allergen-induced allergic rhinitis situations as a post-marketing dedication, ARS Pharma anticipates a resubmission to the FDA within the first half of 2024, positioning ARS Pharma for an anticipated FDA motion date within the second half of 2024.
ARS Pharma expects to have anticipated money, money equivalents and short-term investments readily available of roughly $195 million on the time of the anticipated launch of neffy, if authorized within the second half of 2024.
The CRL requested further info on nitrosamine impurities to be examined for primarily based on new draft steerage issued after the neffy NDA submission. ARS Pharma doesn’t consider the extra testing can be a rate-limiting step for its resubmission to the FDA.
A advertising and marketing authorization utility for neffy can also be underneath assessment by the European Medicines Company with a Committee for Medicinal Merchandise for Human Use opinion anticipated by yr finish 2023. Submissions to different regulatory authorities in further nations are deliberate for 2024.
About Kind I Allergic Reactions, together with Anaphylaxis
Kind I extreme allergic reactions are critical and doubtlessly life-threatening occasions that may happen inside minutes of publicity to an allergen and require speedy therapy with epinephrine, the one FDA-approved medicine for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are nicely printed limitations that end in 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 gadgets. There are roughly 40 million individuals in america who expertise Kind I extreme allergic reactions as a result of meals, venom or insect stings. Of these, solely 3.3 million presently have an lively epinephrine autoinjector prescription, and of these, solely half persistently carry their prescribed autoinjector. Even when sufferers or caregivers carry an autoinjector, greater than half both delay or don’t administer the machine when wanted in an emergency.
About ARS Prescription drugs, Inc.
ARS Pharma is a biopharmaceutical firm devoted to empowering at-risk sufferers and caregivers to raised defend sufferers from extreme allergic reactions that might result in anaphylaxis. The Firm is growing neffy® (additionally known as ARS-1), an intranasal epinephrine product in medical improvement for sufferers and their caregivers with Kind I allergic reactions together with meals, medicines and bug bites that might result in life-threatening anaphylaxis. For extra info, go to www.ars-pharma.com.
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” inside the which means of the Personal Securities Litigation Reform Act of 1995. These statements embrace, however will not be restricted to ARS Pharma’s capability to finish the newly required trial and supply the extra info requested by the FDA within the CRL on the timing anticipated, or in any respect; the potential approval of neffy; the anticipated timing for the Committee for Medicinal Merchandise for Human Use opinion with respect to the advertising and marketing authorization utility for neffy; the anticipated submissions of neffy to different regulatory authorities in further nations and the timing thereof; ARS Pharma’s money, money equivalents and short-term investments readily available upon any future approval of neffy; 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 reminiscent of “anticipate,” “plans,” “expects,” “will,” “potential” and related expressions are supposed to determine forward-looking statements. These forward-looking statements are primarily based 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 may differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, which embrace, with out limitation, the power to acquire and keep regulatory approval for neffy; the power to profitable full the newly requested trial on the timeframe anticipated in any respect, because of challenges inherent to enrolling, conducting and finishing medical trials; the outcomes of the brand new medical trial might not assist the approval of neffy; outcomes from medical trials will not be indicative of outcomes that could be noticed sooner or later; potential security and different issues from neffy; the labelling for neffy, if authorized; the scope, progress and growth of growing and commercializing neffy; the scale and progress 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; and the influence of presidency legal guidelines and rules. Extra dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included underneath the caption “Threat Components” in ARS Pharma’s Quarterly Report on Type 10-Q for the quarter ended June 30, 2023, filed with the Securities and Trade Fee on August 10, 2023. This doc will also be accessed on ARS Pharma’s internet web page at ir.ars-pharma.com by clicking on the hyperlink “Financials & Filings.”
The forward-looking statements included on this press launch are made solely as of the date hereof. ARS Pharma assumes no obligation and doesn’t intend to replace these forward-looking statements, besides as required by regulation.
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