An unlucky results of some oral meals challenges (OFCs) is the onset of anaphylaxis. In such instances, epinephrine is straight away administered.
In response to a press launch from ARS Prescription drugs, their neffy emergency epinephrine spray was utilized in a scientific examine of 15 pediatric sufferers ages 6-17 that suffered anaphylaxis because of OFCs.
Six topics (15-30 kg physique weight) had been dosed with 1 mg neffy, and 9 topics (30 kg+ physique weight) had been dosed with 2 mg neffy.
100% of the sufferers responded to remedy with neffy with a median time to finish decision of anaphylactic signs in 16 minutes.
One of many sufferers suffered a biphasic response 2 hours 45 minutes later and required extra remedy. For needle-based epinephrine administration in kids with food-induced anaphylaxis, biphasic reactions happen in 12.8% of instances.
Scientific information on this trial was in step with historic scientific response information for injection merchandise.
ARS stays on monitor to announce topline outcomes from its repeat dose examine of neffy beneath nasal allergen problem circumstances within the first quarter of 2024 as required by the FDA in September 2023. The corporate plans to re-submit its New Drug Utility mid-first half of 2024 with an anticipated US launch, if accepted, within the mid-second half of 2024.
You may learn the ARS press launch in its entirety — together with plans to current new scientific at this yr’s annual AAAAI assembly later this month — beneath.
ARS Prescription drugs to Current Constructive Scientific Efficacy Knowledge for neffy® (epinephrine nasal spray) at 2024 AAAAI Annual Assembly
February 5, 2024
- Six posters and oral displays to be offered, together with efficacy information for neffy from two distinct scientific research in oral meals problem induced anaphylaxis and power urticaria sufferers
- 100% response charge with a single dose of neffy noticed in pediatric topics experiencing anaphylaxis signs following oral meals problem; efficacy information supposed to help post-marketing promotion of neffy, if accepted
- On monitor to report topline ends in Q1 2024 from repeat dose examine of neffy beneath nasal allergen circumstances requested by FDA, with NDA re-submission anticipated in the course of H1 2024
SAN DIEGO, Feb. 05, 2024 (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, at the moment introduced that new scientific information, together with efficacy outcomes supporting neffy (epinephrine nasal spray), shall be offered through the 2024 American Academy of Allergy, Bronchial asthma and Immunology (AAAAI). The assembly shall be held February 23-26, 2024, in Washington, DC.
One late-breaking presentation stories efficacy outcomes for the primary time with neffy in pediatric sufferers who developed anaphylaxis signs following oral meals problem. The efficacy information demonstrated that 100% of sufferers responded to a single dose of neffy with a 16-minute median time to finish decision of anaphylaxis signs.
“I imagine the sturdy and speedy scientific responses noticed with neffy throughout anaphylaxis because of oral meals problem show that neffy is a minimum of as efficient as injection,” says Motohiro Ebisawa, M.D., Ph.D., Director of Scientific Analysis Heart for Allergy and Rheumatology at Sagamihara Nationwide Hospital, Previous-President of the World Allergy Group, and Principal Investigator of the examine. “My allergy colleagues and I are eagerly awaiting regulatory approval of neffy, in order that we will prescribe this needle-free and easy-to-carry remedy choice to our extreme allergy sufferers – a lot of whom don’t carry, don’t administer or delay use of epinephrine autoinjectors.”
A second presentation particulars the statistically vital and clinically significant reductions in urticaria signs achieved by neffy throughout all endpoints in its randomized, managed proof-of-concept examine.
“Epinephrine is the first-line remedy and solely remedy for anaphylaxis that reduces danger of hospitalization and loss of life,” says Sarina Tanimoto, M.D., Ph.D., Chief Medical Officer and Co-Founding father of ARS Pharma. “The information from these research to be offered at AAAAI in anaphylaxis and urticaria sufferers demonstrated that neffy labored as nicely and as quick as delivering epinephrine by injection, however with out the necessity for a needle and its accompanying limitations.”
ARS Pharma will share information throughout six displays, additional demonstrating the corporate’s dedication to advancing its scientific management place within the allergy neighborhood. Further neffy information to be offered embody pharmacokinetic/ pharmacodynamic (PK/PD) results in pediatric topics, improved temperature stability versus injection merchandise, enhancements in affected person high quality of life, and elevated gadget carriage, use and time to make use of charges.
Design of neffy efficacy examine in oral meals problem induced anaphylaxis
This examine (jRCT2031230143) assessed the security and efficacy of a single dose of neffy given to pediatric sufferers with anaphylaxis signs induced by an oral meals problem.
2 mg (30 kg+ physique weight) or 1 mg (15-30 kg physique weight) doses of neffy had been administered when sufferers exhibited gastrointestinal, respiratory or circulatory signs that had been grade two or increased on the three-grade scale within the Severity Classification of Organ Signs by the Japanese Society of Allergology Anaphylaxis Pointers 2022.1
Outcomes from neffy efficacy examine in oral meals problem induced anaphylaxis
A complete of 15 sufferers aged 6 to 17 had been enrolled; 6 topics (15-30 kg physique weight) had been dosed with 1 mg neffy, and 9 topics (30 kg+ physique weight) had been dosed with 2 mg neffy.
Remedy tips point out a second dose of epinephrine must be given if scientific response will not be noticed throughout the first quarter-hour.
- 100% of the sufferers responded to the only dose of neffy
- After dosing neffy, the median time to finish decision of anaphylaxis signs was 16 minutes.
- 1 of 15 sufferers (6.7%) skilled a biphasic response 2 hours and 45 minutes following full decision of signs with the only dose of neffy and required extra epinephrine remedy. For epinephrine injection merchandise, biphasic reactions are reported to happen at a frequency of 12.8% in kids with food-induced anaphylaxis (Gupta et al. JACI: In Follow, 2021).
- For epinephrine injection merchandise, two or extra doses of epinephrine are required for 10.8% of oral meals challenges handled with epinephrine (n = 2,436 occasions) (Patel et al. JACI, 2021).
- Scientific information on this neffy trial is due to this fact according to historic scientific response information for injection merchandise.
The trial demonstrated security outcomes just like the beforehand reported security profile of neffy and accepted epinephrine merchandise with opposed occasions reported in 7 topics dosed with neffy, all of which had been gentle or reasonable and most of which resolved rapidly.
ARS Pharma stays on monitor to announce topline outcomes from its repeat dose examine of neffy beneath nasal allergen problem circumstances within the first quarter of 2024 and re-submit its NDA mid-first half of 2024 with an anticipated PDUFA motion date and US launch, if accepted, within the mid-second half of 2024.
The neffy displays at AAAAI are listed beneath:
neffy scientific efficacy research
Title: neffy, epinephrine nasal spray, Demonstrates a Constructive Efficacy and Security Profile for the Remedy of Allergic Reactions in Pediatric Sufferers at-Threat of Anaphylaxis: Section 3 Research Outcomes
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Session: Late-Breaking Poster Session II
Location: Conference Heart, Stage 2, Corridor D
Title: ARS-2, Low-Dose Intranasal Epinephrine, Improves Urticaria Scores in Sufferers with Frequent Urticaria Flares: Section 2 Research Outcomes
Date & Time: Monday, February 26, 2024 12:45 to 2:00 p.m. ET
Poster Quantity: 788
Session: Novel Insights into Urticaria/Angioedema/Atopic Dermatitis
neffy PK/PD and product formulation research
Title: Pediatric Doses of neffy (Intranasal Nasal Spray) Exhibit Pharmacokinetic Profiles That Are Equal to Epinephrine Injections Merchandise
Date & Time: Friday, February 23, 2024, 3:15 to 4:15 p.m. ET
Poster Quantity: 033
Location: Conference Heart, Stage 2, Corridor D
Title: Comparative Stability of Three Epinephrine Merchandise Underneath Excessive Temperature Situations
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Quantity: L32
Location: Conference Heart, Stage 2, Corridor D
neffy real-world affected person burden research
Title: Impact of Needle-Free Epinephrine on Meals Allergy Affected person and Caregiver High quality of Life
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Quantity: 240
Location: Conference Heart, Stage 2, Corridor D
Title: A Survey of Allergists, Pediatricians, and Main Care Physicians Concerning the Utilization of Epinephrine
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Quantity: 299
Location: Conference Heart, Stage 2, Corridor D
About Kind I Allergic Reactions together with Anaphylaxis
Kind I extreme allergic reactions are severe and probably life-threatening occasions that may happen inside minutes of publicity to an allergen and require speedy remedy with epinephrine, the one FDA-approved remedy for these reactions. Whereas epinephrine autoinjectors have been proven to be extremely efficient, there are nicely revealed limitations that lead to many sufferers and caregivers delaying or not administering remedy in an emergency scenario. These limitations embody concern of the needle, lack of portability, needle-related security issues, lack of reliability, and complexity of the units. There are roughly 40 million folks in america who expertise Kind I extreme allergic reactions. Of these, solely 3.3 million at present have an energetic epinephrine autoinjector prescription, 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 gadget 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 themselves from extreme allergic reactions that might result in anaphylaxis. The Firm is creating neffy (beforehand known as ARS-1), an intranasal epinephrine product in scientific growth 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.
Ahead-Trying Statements
Statements on this press launch that aren’t purely historic in nature are “forward-looking statements” throughout the that means of the Personal Securities Litigation Reform Act of 1995. These statements embody, however will not be restricted to: the import of examine/trial outcomes, together with whether or not a regulatory company will finally decide that neffy is protected and efficient; ARS Pharma’s plan to announce topline outcomes from its repeat-dose examine beneath nasal allergen problem circumstances and file its NDA re-submission to the FDA; the anticipated PDUFA motion date for neffy; the potential regulatory approval of neffy and the anticipated US launch of neffy, if accepted, and the timing thereof; whether or not allergy physicians will prescribe neffy, if accepted, as a substitute of injectable epinephrine; and different statements that aren’t historic reality. 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 resembling “await,” “imagine,” “show,” “plan,” “anticipate,” “will,” “potential,” “on monitor to,” and related expressions are supposed 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 may differ materially from these anticipated in such forward-looking statements because of numerous dangers and uncertainties, which embody, with out limitation, the flexibility to efficiently full the repeat-dose examine beneath nasal allergen problem circumstances throughout the anticipated timeframe, because of challenges inherent to enrolling, conducting and finishing scientific trials; examine limitations, together with comparatively small pattern dimension and the absence of a comparator arm; the outcomes of the repeat-dose examine beneath allergen-induced allergic rhinitis circumstances might not help the approval of neffy; outcomes from scientific trials might not be indicative of outcomes which may be noticed sooner or later; it’s doable that the FDA might refuse to simply accept our deliberate NDA for neffy or might conclude after evaluate of our information that our NDA utility is inadequate to acquire regulatory approval for neffy; the flexibility to acquire and preserve regulatory approval for neffy; potential security and different problems from neffy; the labelling for neffy, if accepted; ARS Pharma’s capacity to guard its mental property place; the scope, progress and growth of creating and commercializing neffy; the scale and progress of the marketplace for neffy and the speed and diploma of market acceptance thereof vis-à-vis intramuscular injectable merchandise; and the affect of presidency legal guidelines and rules. Further dangers and uncertainties that might trigger precise outcomes and outcomes to vary materially from these contemplated by the forward-looking statements are included beneath the caption “Threat Elements” in ARS Pharma’s Quarterly Report on Type 10-Q for the quarter ended September 30, 2023, filed with the Securities and Alternate Fee on November 9, 2023. This doc may 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.
ARS Pharma Media Contacts:
Laura O’Neill
Laura.oneill@finnpartners.com
ARS Pharma Investor Contacts:
Justin Chakma
ARS Prescription drugs
justinc@ars-pharma.com
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1 Anaphylaxis signs that triggered dosing of neffy needed to be a minimum of reasonable in severity per the rules and will embody: generalized urticaria/exanthema/wheal pruritus, swollen face, throat ache, reasonable stomach ache, recurrent emesis/diarrhea, repetitive cough, chest tightness/wheezing detectable by way of auscultation, pale face/gentle hypotension/tachycardia (>15 beats/min), light-headedness/feeling of “pending doom”/somnolence/headache.
ARS Prescription drugs, Inc.
