Bryn Pharma announced the publication of a poster presenting data from a Phase 1 PK/PD study of its BRYN-NDS1C intranasal epinephrine, which is delivered via an Aptar Pharma Bidose nasal device. In October 2019, Bryn announced that it had raised $17.5 million for development of BRYN-NDS1C, which has received Fast Track designation from the FDA.
The study, which enrolled 95 healthy adults, compared the intranasal epinephrine with intramuscular (IM) epinephrine via EpiPen and IM epinephrine via manual syringe. According to Bryn, 2 6.6 mg doses of intranasal epinephrine resulted in increased absorption compared to a single 0.3 mg dose of IM epinephrine and 2 doses of intranasal epinephrine in the same nostril resulted in increased absorption compared to 2 doses of IM epinephrine injected in opposite thighs.
The company also said that “At most time points, a greater percentage of participants achieved epinephrine concentrations of between 100 and 200 pg/mL after 2 IN epinephrine doses in the same nostril (IN epinephrine 2 x 6.6 mg) compared with a single dose of IM epinephrine (0.3 mg).”
Bryn Pharma CEO David Dworaczyk commented, “The study demonstrated that intranasal epinephrine delivered through a bi-dose nasal spray is a potentially novel therapeutic option in anaphylactic treatment, which may allow patients to replace two auto-injectors with a single nasal device. This is a critical benefit to patients and caregivers in an emergency environment because 30% require a second dose to provide adequate treatment to a patient in anaphylaxis.”
Read the Bryn Pharma press release.
