insys Therapeutics’ epinephrine nasal spray for the treatment of anaphylaxis has received Fast Track designation from the FDA, the company said. In June 2018, Insys said that a Phase 1 study of the nasal spray showed that its bioavailability was similar to that of intramuscular formulations.
The company has several OINDPs in development, including a dronabinol inhaler and a naloxone nasal spray.
Insys Senior VP of Regulatory Affairs Steve Sherman commented, “The receipt of Fast Track designation represents a significant milestone for Insys and our clinical development of this novel drug-device combination. We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible.”
Read the Insys Therapeutics press release.
