Bryn Pharma — the North Carolina-based company developing an emergency epinephrine device you spray in your nose instead of inject in your thigh, announced positive results from a study at this year’s AAAAI meeting.
Results from the study demonstrated that administration of epinephrine with one spray/dosing from Bryn’s two-dose nasal spray device resulted in a favorable release profile with both short- and long-term pharmacokinetic (PK) outcomes that were comparable to or greater than those seen with administration by a single 0.3 mg epinephrine auto-injector. No safety issues were seen and there were no serious or unexpected adverse events with either intranasal (IN) or intramuscular (IM) dosing.
Said Dr David Dworaczyk, CEO of Bryn Pharma:
These clinical results show that a single spray from our bi-dose nasal spray device delivered epinephrine at levels equaling or exceeding those administered with a single 0.3 mg epinephrine auto-injector, potentially allowing patients to replace two auto-injectors with a single nasal device. Up to 30% of patients experiencing an anaphylactic event require a second dose of epinephrine, and our bi-dose nasal spray device meets this critical need along with other advantages including needle-free delivery, ease of use and portability. We will continue to work diligently to complete the required steps remaining to gain FDA approval.
The open-label, randomized 5-treatment, 5-way crossover study included 25 healthy participants aged 19–45 years. The epinephrine administered ranged from 4.4mg to 13.2mg intranasally compared to 0.3mg dose administered intramuscularly.
Epinephrine concentrations and cardiovascular effects were measured periodically starting a half-hour before administration to 3 hours afterward.
Epinephrine bioavailability and cumulative pharmacokinetic data demonstrated that the single intranasal 6.6-mg epinephrine dose was comparable to or greater than 0.3mg epinephrine dose delivered via auto-injector, with similar cardiovascular effects.
- Bryn Pharma Announces Presentation Of Positive Clinical Results From Multi-Dose Study Of Bi-Dose Epinephrine Nasal Spray For The Treatment Of Anaphylaxis At AAAAI Virtual Annual Meeting — Bryn Press Release
- 5-Period, 5-Treatment Crossover Study to Compare the Pharmacokinetics of Intranasal and Intramuscular Epinephrine Administration in Healthy Adult Participants — JACI
Hope is on the horizon for nasal spray usage. It’s good news to hear the study on for intranasal use will make it easier for students and adults to carry with them.
That alone makes it worth the cost difference. I wonder if when approved after all the testing., if the drug company will charge a fair price ? Yet to be seen.