Epinephrine autoinjector

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Mesa Science Associates Contributes to Study Demonstrating Efficacy of Intranasal Spray at Treating Anaphylaxis

Retrieved on: 
Tuesday, February 27, 2024

FREDERICK, Md., Feb. 27, 2024 /PRNewswire-PRWeb/ -- Kenneth Dretchen, PhD, of Mesa Science Associates, in collaboration with researchers from Bryn Pharma LLC, Celerion Inc., and Allucent, recently published an article in the Journal of Allergy and Clinical Immunology: Global entitled "A 13.2 mg epinephrine intranasal spray demonstrates comparable pharmacokinetics, pharmacodynamics, and safety to a 0.3 mg epinephrine autoinjector."

Key Points: 
  • The current treatment option of acute anaphylaxis via intramuscular administration of epinephrine (e.g., EpiPen) poses a number of issues.
  • The device itself can be difficult to obtain due to its high cost and limited availability in many countries.
  • The published study was conducted to demonstrate that an intranasal spray is a viable alternative.
  • Mesa Science Associates Inc. is a veteran-owned small business located within the Frederick Innovative Technology Center Inc. (FITCI) at 321 Ballenger Center Drive, in Frederick, Md.

Lawsuit: North Texas Daycare's Negligence Threatened Toddler's Life

Retrieved on: 
Monday, February 12, 2024

ALLEN, Texas, Feb. 12, 2024 /PRNewswire/ -- The mother of a 3-year-old girl is suing the daycare center Allen Knowledge Beginnings, alleging repeated negligence regarding the toddler's life-threatening fish allergy. In the complaint, Danielle Levy states that caregivers at the facility gave her daughter fish sticks on two separate occasions within the span of four months, despite Levy notifying the center of her daughter's allergy and providing an emergency plan at the time of her enrollment. The second time the daycare center served the girl fish sticks, in July 2022, she went into anaphylaxis and was found in a bathroom barely breathing with a swollen tongue, lips, and face, according to the suit. 

Key Points: 
  • ALLEN, Texas, Feb. 12, 2024 /PRNewswire/ -- The mother of a 3-year-old girl is suing the daycare center Allen Knowledge Beginnings, alleging repeated negligence regarding the toddler's life-threatening fish allergy.
  • First responders administered two EpiPens and gave the toddler an oral medication to combat her anaphylaxis while en route to the hospital.
  • "In a literal life-or-death situation involving my daughter's life, Allen Knowledge Beginnings failed to act quickly," Levy says.
  • Despite Allen Knowledge Beginnings advertising itself as a food allergy-safe facility, it failed to deliver on its promise, according to the suit.

FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book

Retrieved on: 
Wednesday, January 3, 2024

“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.

Key Points: 
  • “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan.
  • “The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens.
  • Last month, the FTC issued a policy statement that warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book.
  • Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law.

Aquestive Therapeutics Doses First Patient in Phase 3 Pivotal Clinical Study Evaluating Pharmacokinetics and Pharmacodynamics of Anaphylm™ (epinephrine) Sublingual Film

Retrieved on: 
Tuesday, December 5, 2023

Anaphylm is the Company’s orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.

Key Points: 
  • Anaphylm is the Company’s orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.
  • The two-part, Phase 3, single-center, open-label, randomized study is designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine IM injection and epinephrine autoinjectors (EpiPen® and Auvi-Q®) in healthy adult subjects.
  • The primary objective is to compare the PK of epinephrine following the single administration of Anaphylm to single administration of epinephrine IM injection in healthy adult subjects.
  • The secondary objectives include evaluating PK sustainability following repeat administration and evaluating the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors.

Nasus Pharma Announces Positive Clinical Results of Recent Phase 2 Study With FMXIN002 Intranasal Epinephrine

Retrieved on: 
Tuesday, December 5, 2023

TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.

Key Points: 
  • TEL AVIV, Israel, Dec. 5, 2023 /PRNewswire/ -- Nasus Pharma Ltd a clinical-stage biopharmaceutical company focused on developing a needle-free, powder-based Intranasal (PBI) product portfolio to address acute medical conditions announced positive results from its latest clinical study of intranasal powder-based Epinephrine.
  • Nasus Pharma recently completed an additional phase 2 study (NP-006-Epinephrine) confirming the superiority and safety of its lead FMXIN002 Intranasal Epinephrine product.
  • The recent clinical study explored the safety and efficacy of FMXIN002 in its intended clinical dose and provided additional compelling evidence to the robustness of Nasus Pharma intranasal powder technology already tested in a  prior pilot study ( Tal, et al.
  • "This phase 2  study indicates that powder-based intranasal epinephrine can offer significant clinical advantages, as compared to the currently-available intramuscular route of drug administration and other solution-based intranasal epinephrine programs in development.

New York Festivals 2024 Health Awards Open for Entries

Retrieved on: 
Thursday, October 26, 2023

NEW YORK, Oct. 26, 2023 /PRNewswire/ -- The New York Festivals  2024 NYF Health Awards, celebrating excellence in Healthcare, Wellness and Pharmaceutical advertising,  is now open for entries.

Key Points: 
  • NYF Health Appoints Executive Jury Chairs: Susan Perlbachs, CCO for EVERSANA INTOUCH will Lead Health & Wellness Jury; Bruno Abner, Former CCO for McCann Health New Jersey Named Head of Pharma Jury
    NEW YORK, Oct. 26, 2023 /PRNewswire/ -- The New York Festivals 2024 NYF Health Awards , celebrating excellence in Healthcare, Wellness and Pharmaceutical advertising,  is now open for entries .
  • For 2024, New York Festivals Health Awards will once again hold live, face-to-face Executive Jury sessions in New York City with two separate Executive Juries who will judge Health & Wellness and Pharma.
  • "NYF Health is honored that these esteemed healthcare industry leaders will lead the 2024 Executive Jury panels," said Scott Rose, President, New York Festivals Advertising Awards Competitions.
  • New York Festivals Health Awards brings together the brightest, most creative minds in our industry to recognize the best in health and wellness communications.

AAFA Joins Advocates on Capitol Hill in Support of Dillon’s Law and Expanded Access to Epinephrine

Retrieved on: 
Thursday, October 26, 2023

Dillon's Law is named after Dillon Mueller, an 18-year-old boy whose life was tragically cut short due to a severe allergic reaction to a bee sting.

Key Points: 
  • Dillon's Law is named after Dillon Mueller, an 18-year-old boy whose life was tragically cut short due to a severe allergic reaction to a bee sting.
  • Dillon had never experienced such a reaction before and did not have a prescription for epinephrine.
  • “The Dillon Mueller case is exactly why we need to expand access to rescue medication like epinephrine to treat anaphylaxis,” said AAFA president and CEO Kenneth Mendez.
  • Scott Walker at Mishicot High School in December 2017 and we then began our ‘Do it for Dillon’ epinephrine training program.

Single and Repeat Dose Clinical Study of neffy (epinephrine nasal spray) Published in the Journal of Allergy and Clinical Immunology

Retrieved on: 
Tuesday, October 3, 2023

JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology.

Key Points: 
  • JACI is the official scientific publication of the American Academy of Allergy, Asthma and Immunology and the most cited journal in the field of allergy and clinical immunology.
  • The clinical study evaluated single and repeat doses of neffy compared to single and repeat doses of approved injection products in healthy subjects.
  • For repeat doses of neffy, mean maximum changes in PD responses for both blood pressure and heart rate were statistically greater than repeat doses of EpiPen.
  • In addition, the PK profile for a second dose of neffy was approximately dose-proportional, unlike EpiPen, where the second dose delivered less incremental epinephrine exposure than the first dose.

What is food protein-induced enterocolitis syndrome or FPIES? And are more babies getting it?

Retrieved on: 
Monday, July 31, 2023

But fewer people have heard of food protein-induced enterocolitis syndrome (FPIES).

Key Points: 
  • But fewer people have heard of food protein-induced enterocolitis syndrome (FPIES).
  • It can be caused by a variety of foods including some not usually associated with food allergies like rice, oats and vegetables.
  • The most common symptom is profuse, repetitive vomiting one to four hours after eating the food.

What is it that causes symptoms?

    • We don’t currently know much about the immune dysregulation that causes FPIES.
    • That also means medications used for treatment of these types of allergies (such as EpiPens and antihistamine) do not work in FPIES.

Missed cases?

    • Symptoms of FPIES can be mistaken for other conditions such as gastroenteritis (“gastro”), twisted bowel or serious blood infections.
    • This can delay diagnosis.
    • Unlike most other types of food allergies, which have reactions caused by allergy antibodies, there is no blood test to diagnose FPIES.

How common is FPIES and is it becoming more common?

    • Because it is under-recognised and difficult to diagnose, estimates of FPIES prevalence vary considerably – between 0.015% to 0.7% of infants.
    • Although data is sparse, some studies report an increase in rates of FPIES.
    • An increasing awareness of FPIES, as well as improvements in diagnosis, mean FPIES diagnoses may increase without a true increase in the condition.

What foods trigger FPIES?

    • In Australia, rice is the most reported FPIES trigger, with cow’s milk, soy and eggs also common.
    • Cow’s milk is the most common reported trigger in the United States and Europe.
    • Fish is a common trigger reported in Mediterranean countries, and increasingly reported as a cause of FPIES in older children and adults.
    • Those with FPIES need to avoid the foods that trigger FPIES reactions, but there is often no need to avoid other non-related foods.

What to do if you suspect you or your child has FPIES

    • If you think that you or your child may have FPIES, talk to your doctor.
    • The next step may be developing an action plan for a FPIES reaction.