Aside from their size and needle, one major complaint about epinephrine auto-injectors is that they cannot withstand significant “temperature excursions,” such as when the device is left in a car on a hot day.
The concern is twofold: the device used to inject the epinephrine is complex and may warp under extreme temperatures, and the epinephrine solution itself may lose potency.
Aquestive Therapeutics is in the process of advancing a sublingual epinephrine alternative through clinical trials. Anaphylm™ is a small rectangular film placed under the tongue to deliver epinephrine in an anaphylactic emergency.
The company presented data from tests of its candidate under high temperatures at this year’s AAAAI annual meeting.
They stored Anaphylm at 122°F (50°C) for 28 days, tested its potency, then stored it at room temperature (77°F/25°C) for another 12 months and tested its potency again. After the initial 28 days at high temperature, the drug remained 97.7% potent, then after the subsequent year, tested at 96.9%.
Another test saw Anaphylm sampled after the temperature was ratcheted up to 158°F (70°C) for seven days, then tested again after 12 months at room temperature. The drug’s potency remained at 96.6% after the initial test and 91.7% after the year.
The study demonstrated Anaphylm’s stability across a wide range of extreme temperatures and shows the drug maintains potency throughout its shelf-life under real-world conditions.
