Results show NDS1C provides enhanced absorption in adults with or without congestion compared to current first-line intramuscular epinephrine and auto-injector-administered treatments
The study also found that NDS1C was safe and generally well-tolerated. If approved, NDS1C may offer patients at risk of anaphylaxis a practical alternative to needle-based administration routes
Bryn Pharma, LLC announced positive clinical data supporting use of its epinephrine nasal spray – known as NDS1C – in adults with or without congestion, presented during the 2023 American College of Allergy Asthma and Immunology Annual Scientific Meeting (ACAAI).
The open-label study aimed to demonstrate that in real-world settings, nasal congestion, which is a common symptom of various medical conditions including anaphylaxis, does not negatively affect the absorption and bioavailability of NDS1C. The results showed that NDS1C, in fact, provides enhanced absorption in adults with or without congestion compared to intramuscular epinephrine and epinephrine administered via auto-injector, currently the first-line treatments for anaphylaxis.
Said Sandy Loreaux, CEO of Bryn Pharma:
This study further validates the clinical utility of NDS1C, showing it not only offers improved absorption of active drug compared to currently available products on the market, but also offers patients at risk of anaphylaxis a potentially safe and effective alternative to needle-based administration.
Unlike other epinephrine nasal spray candidates in development, NDS1C is the only intranasal epinephrine product with publicly available data demonstrating enhanced absorption in the presence of congestion. We are pleased that our development program continues to demonstrate that congestion does not have a negative impact on the pharmacokinetic profile of NDS1C.
Safety results from the study found that NDS1C was safe and generally well-tolerated. There were minimal treatment effects on heart rate and systolic/diastolic blood pressure, with no correlation between drug concentration and these effects observed. Treatment-emergent adverse event incidences with 13.2 mg NDS1C with and without nasal allergy challenge in opposite nostrils were 54% and 64%, respectively, and in the same nostril were 44% and 48%, respectively. The most common adverse events were mild nausea and headache.
Said Michael Blaiss, MD, clinical professor of pediatrics at Medical College of Georgia and past president of ACAAI:
Patients and families are in need of an efficient epinephrine delivery device that simply does not involve needles. As a clinician, it is highly encouraging to see data demonstrating that intranasally administered epinephrine actually leads to enhanced absorption of this life-saving drug in people with congestion compared to the currently available intramuscular and autoinjector options. If approved, NDS1C will be a welcomed alternative to healthcare professionals to help this community address the inherent challenges that come with using injection therapy so they can better manage their daily lives.
The open-label, four-period, four-treatment, partial-crossover study evaluated 50 healthy adults with confirmed seasonal allergies. Participants were enrolled in either the opposite nostrils epinephrine nasal spray cohort or the same nostril cohort. In the first period, both cohorts received 13.2 mg of NDS1C administered by two consecutive sprays, with congestion induced by nasal allergy challenge. During the second and third periods, both cohorts were administered 0.3 mg epinephrine by IM auto-injector or 0.5 mg epinephrine IM by manual syringe. The fourth period included 13.2 mg epinephrine nasal spray (NDS1C) administered by two consecutive sprays, without congestion. The study included a washout period of one day between Periods 1-3 and of at least 14 days between Periods 1 and 4. All treatments were administered by trained clinical personnel.
