Neffy (epinephrine) / ARS Pharma, Neurelis - LARVOL DELTA

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: ARS Pharmaceuticals, Inc.

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Emerging therapeutics in the management of food allergy. (PubMed, Curr Probl Pediatr Adolesc Health Care) - "In this review, we outline the clinical management of food allergy, including mainstream non-pharmaceutical therapies, such as food oral immunotherapy (OIT), as well as three FDA-approved therapies: Palforzia (pharmaceutical peanut oral immunotherapy), omalizumab (anti-IgE monoclonal antibody), and Neffy (intranasal epinephrine). We also discuss emerging therapies, including novel routes of immunotherapy administration (epicutaneous, subcutaneous, sublingual, oral mucosal) and existing immunomodulatory therapies undergoing trials for use in food allergy, including dupilumab (anti-IL-4 and IL-13 monoclonal antibody), abrocitinib (oral JAK inhibitor) and abatacept (IgG-CTLA-4 fusion protein)."

Journal • Allergy • Food Hypersensitivity • Immunology • CTLA4 • IL13 • IL4

Pharmacokinetics and pharmacodynamics of neffy, epinephrine nasal spray, in pediatric allergy patients. (PubMed, J Allergy Clin Immunol Pract) - "In pediatric subjects both the 1 and 2 mg doses of neffy resulted in mean maximum concentration values that are expected to be both safe and efficacious. Age-related differences in pharmacodynamic responses were noted; however, these differences are likely attributable to expected age-based differences in physiology."

Journal • PK/PD data • Allergy • Immunology • Pediatrics

ARS Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Total revenue for the fourth quarter of 2024 was $86.6 million, which included $6.7 million in net product revenue from neffy sales in the United States, $73.5 million in collaboration revenue from ALK, $6 million in collaboration revenue from the company’s licensing partner in Japan (Alfresa Pharma), and $0.4 million in revenue from supply agreements. Full-year 2024 revenue totaled $89.1 million, reflecting $7.3 million in neffy sales, $81.5 million in collaboration revenue, and $0.4 million from supply agreements...ARS Pharma projects to receive cash proceeds from milestone payments by ALK of approximately $5 million in both the second and fourth quarters of 2025...Multiple favorable coverage decisions secured...with ongoing discussions and contract negotiations with other key payors, keeping the company on track for more than 60% access to commercial lives under contract by the end of the first quarter of 2025, and more than 80% by early third quarter of 2025."

Commercial • Sales • Allergy • Food Hypersensitivity • Immunology

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms (GlobeNewswire) - "ARS Pharmaceuticals...announced today that the U.S. Food and Drug Administration (FDA) has approved neffy 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years....The approval of neffy 1 mg is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products....ARS Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025."

FDA approval • Launch US • Allergy

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy (clinicaltrials.gov) - P4 | N=600 | Not yet recruiting | Sponsor: ARS Pharmaceuticals, Inc.

New P4 trial • Allergy

ARS Pharmaceuticals to Showcase Innovation and Present Data on neffy (epinephrine nasal spray) at 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting (GlobeNewswire) - "ARS Pharmaceuticals...announced today that nine presentations will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting, February 28 to March 3, in San Diego, California. The oral presentation and posters will feature data from a wide range of studies, including pharmacokinetics and pharmacodynamics of intranasal epinephrine under normal and various conditions, physiological responses between adults and children who are administered epinephrine, and the pre-treatment journey of patients with allergic conditions. In addition to the presentations, ARS Pharma will participate in and host a variety of onsite activities during the meeting."

Clinical data • PK/PD data • Allergic Rhinitis

Difference in Physiology Between Adults and Children in Response to Epinephrine Administration (AAAAI-WAO 2025) - "Neffy (epinephrine nasal spray) is a treatment option of severe allergic reactions, including anaphylaxis. Conclusions In pediatric subjects, Neffy demonstrated comparable-to-greater absorption relative to adults, with a less pronounced SBP response and more transient DBP response. These differences in epinephrine-related BP response are attributed to normal, age-related differences in vascular elasticity, with more pronounced β 2 -adrenergic receptor-mediated vasodilation in children."

Clinical • Immunology • Pediatrics

Pharmacokinetics and Pharmacodynamics of Repeat Dose of Epinephrine Nasal Spray and Manual Intramuscular Injection in Chinese Subjects Under Normal Condition (AAAAI-WAO 2025) - "Mean maximum effect (E max ) values were 30.0 mmHg ( Neffy 2 mg) and 27.8 mmHg (IM 0.5 mg) for SBP, 10.9 mmHg ( Neffy 2 mg) and 8.80 mmHg (IM 0.5 mg) for DBP, and 20.9 bpm ( Neffy 2 mg) and 17.1 bpm (IM 0.5 mg) for PR. Conclusions Repeated administration of Neffy 2 mg to healthy Chinese subjects results in pharmacokinetic and pharmacodynamic profiles that were comparable to or better than those of IM 0.5 mg."

Clinical • PK/PD data • Allergy • Immunology

Pharmacokinetics of Epinephrine Nasal Spray under Various Conditions (AAAAI-WAO 2025) - "Mean C max values following repeated doses were 1000 pg/mL ( Neffy under normal condition), 852 pg/mL ( Neffy during allergic rhinitis), 430 pg/mL (IM under normal conditions), and 495 pg/mL (IM during allergic rhinitis). Conclusions Across multiple common nasal conditions epinephrine exposure via Neffy is comparable to or greater than following IM, suggesting that Neffy is a safe and effective first-line therapy for the treatment of severe allergic reactions, including anaphylaxis."

PK/PD data • Allergic Rhinitis • Immunology • Inflammation

Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injections in Chinese Subjects Under Allergic Rhinitis Condition (AAAAI-WAO 2025) - "Mean maximum effect (E max ) values of systolic blood pressure (SBP) (mmHg), diastolic blood pressure (DBP) (mmHg), and pulse rate (PR) (bpm) were 24.9 ( Neffy 2 mg), 16.6 (IM 0.5 mg), and 10.7 (IM 0.3 mg) for SBP, 10.9 ( Neffy 2 mg), 5.58 (IM 0.5 mg), and 4.93 (IM 0.3 mg) for DBP, and 17.4 ( Neffy 2 mg), 14.6 (IM 0.5 mg), and 10.7 (IM 0.3 mg) for PR. Conclusions When administered to Chinese subjects with naturally occurring allergic rhinitis, Neffy 2 mg resulted in pharmacokinetic and pharmacodynamic parameters that were comparable to/better than IM 0.3 or 0.5 mg."

Clinical • PK/PD data • Allergic Rhinitis • Immunology • Inflammation

Total Nasal Symptom Scores Remain Consistent in Response to Repeated Nasal Allergen Challenges (AAAAI-WAO 2025) - "Rationale Assessment of intranasal absorption under conditions of allergic rhinitis was a key part of the development of Neffy (epinephrine nasal spray). Conclusions These results are consistent with a previous report demonstrating the reliability of NAC across two inductions, and further demonstrates its reliability for four inductions with three-week intervals. These findings support the use of NAC to achieve comparable levels of allergic rhinitis symptoms across multiple inductions."

Allergic Rhinitis • Immunology • Inflammation • Pruritus

Pharmacokinetics and Pharmacodynamics of Single Dose of Epinephrine Nasal Spray and Manual Intramuscular Injections via HCP and Self-administration in Chineses Subjects Under Normal Conditions (AAAAI-WAO 2025) - "Mean maximum effect (E max ) values were 23.2 mmHg ( Neffy 2 mg [self-administration]), 20.0 mmHg ( Neffy 2 mg), 14.0 mmHg (IM 0.5 mg), and 13.7 mmHg (IM 0.3 mg) for SBP, 11.7 mmHg ( Neffy 2 mg [self-administration]), 6.84 mmHg ( Neffy 2 mg), 5.84 mmHg (IM 0.5 mg), and 5.29 mmHg (IM 0.3 mg) for DBP and 14.4 bpm ( Neffy 2 mg [self-administration]), 13.2 bpm ( Neffy 2 mg), 12.0 bpm (IM 0.5 mg), and 10.4 bpm (IM 0.3 mg) for PR. Conclusions In healthy Chinese subjects, Neffy 2 mg, (HCP- and self-administered), resulted in pharmacokinetics and pharmacodynamics that were comparable to or greater than IM 0.3 or 0.5 mg."

Clinical • PK/PD data • Allergy • Immunology

Superior Efficacy of Epinephrine Nasal Spray for the Relief of Symptoms Following an Oral Food Challenge (AAAAI-WAO 2025) - "Conclusions Relative to a matched control group, patients receiving neffy as an initial treatment had lower symptom scores within 10 minutes. These data suggest that neffy is a viable needle-free option for management of anaphylaxis."

Clinical • Gastrointestinal Disorder

ARS Pharmaceuticals Announces Preliminary Fourth Quarter 2024 Financial Results and 2025 Objectives for neffy (epinephrine nasal spray) (GlobeNewswire) - "Product revenue: Preliminary neffy net product revenue for the fourth quarter of 2024 was approximately $6.5 million, with total net product sales for 2024 of approximately $7.1 million since neffy became available to wholesalers and pharmacies on September 23, 2024. More than 14,500 neffy two-pack units were delivered in the fourth quarter of 2024, including more than 1,500 units in the last week of 2024...On track for more than 60 percent commercial coverage by the end of the first quarter of 2025, and more than 80 percent commercial coverage by the end of the third quarter of 2025...The sNDA filed with the U.S. FDA for neffy for children who weigh 15 to 30 kg has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025; Based on review timelines and subject to approval, product availability of neffy 1 mg is expected in the second quarter of 2025."

Commercial • Launch US • PDUFA • Sales • Asthma • Respiratory Diseases

ARS Pharmaceuticals Files for Approval of neffy in Canada and the United Kingdom on Behalf of Licensing Partner ALK-Abelló A/S (GlobeNewswire) - "ARS Pharmaceuticals, Inc...announced today that ARS Pharma has filed for approval of neffy (epinephrine nasal spray) 2 mg in Canada and the United Kingdom (U.K.), where it will be marketed as EURneffy, on behalf of its licensing partner, ALK- Abelló A/S (ALK)...In November 2024, ARS Pharma announced a licensing agreement providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S...Under the terms of the licensing agreement, ARS Pharma received an upfront payment of $145 million and is eligible to receive up to an additional $320 million in regulatory and sales milestones, as well as tiered, double-digit royalties in the teens on net sales in licensed geographies...ARS Pharma is also evaluating its intranasal epinephrine technology for the treatment of acute flares in patients with chronic urticaria, with plans to begin a Phase 2b clinical trial in early 2025."

Canada filing • Licensing / partnership • MHRA filing • New P2b trial • Allergy • Urticaria

Alternatives to Injectable Adrenaline for Treating Anaphylaxis. (PubMed, Clin Exp Allergy) - "Neffy, an adrenaline nasal spray, is licensed for use in adult and paediatric patients who weigh at least 30 kg. In the near future, multiple alternatives to injectable adrenaline may be available for managing anaphylaxis, overcoming some, but not all of the limitations of AAIs."

Journal • Review • Allergy • Immunology • Pediatrics

An epinephrine nasal spray (neffy) for anaphylaxis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

Comparative Stability of Three Epinephrine Products Under Extreme Temperature Conditions (AAP-NCE 2024) - "effy (epinephrine nasal spray) was more stable than injection products and remained within shelf-life specifications for potency even after 3-months under extreme temperature conditions (50°C). EpiPen and Symjepi showed rapid and extensive degradation and were subpotent at these extreme temperature conditions after a short period of time. The expiration period for injection products is 18-months, while neffy, a needle-free epinephrine alternative, is anticipated to be launched with an initial expiration period of 24-months."

neffy, nasal epinephrine sprayer, demonstrated successful use by patients and caregivers: Human Factor Findings (AAP-NCE 2024) - "The intended users include adults and children 10-17 years old with severe food allergy patients. Caregivers demonstrated that they were able to administer neffy safely and successfully both once and twice during a simulated allergy emergency, including dosing themselves or a simulated patient. Based on the final intended labeling there were no use errors."

Clinical • Food Hypersensitivity • Immunology

Pediatric doses of neffy (intranasal nasal spray) demonstrate pharmacokinetic profiles that are equivalent to epinephrine injections products (AAP-NCE 2024) - "Pediatric doses of neffy have a favorable safety profile with pharmacokinetic and pharmacodynamic profiles within range of approved injection products. neffy is expected to be a safe and effective option for the treatment of severe allergic reactions and anaphylaxis in pediatric patients."

Clinical • PK/PD data • Immunology • Pediatrics

Perceptions, Realities, and Alternatives in Rescue Epinephrine. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal

ARS Pharmaceuticals Announces U.S. Availability of neffy (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis (GlobeNewswire) - "ARS Pharmaceuticals, Inc...announced today that neffy (epinephrine nasal spray) is now available to patients and caregivers by prescription across the U.S. The U.S. Food and Drug Administration (FDA) approved neffy 2 mg last month for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.)."

Launch US • Allergy • Respiratory Diseases

ARS Pharmaceuticals Launches Pre-Ordering Services for neffy to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis (GlobeNewswire) - "ARS Pharmaceuticals, Inc...announced today pre-ordering services for neffy (epinephrine nasal spray), ensuring swift access upon availability, expected in late September....Pre-ordering can begin immediately via neffy.com."

Commercial • Allergy

Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 in Subjects With Frequent Urticaria Flares (clinicaltrials.gov) - P2 | N=24 | Completed | Sponsor: ARS Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Urticaria