Insys Therapeutics says that it plans NDA submissions for both its naloxone and epinephrine nasal sprays in 2019. The company also noted the potential of regulatory submission for its inhaled dronabinol in the next few years.
According to Insys, a PK study of the naloxone nasal spray “showed a distinctive profile for the . . . nasal spray product candidate in comparison to the current standards” and the company “believes that the characteristics of its drug hold particular relevance in the context of rising rates of overdose from highly potent synthetic opioids, as standard doses of currently approved naloxone products may not be sufficient due to the drug’s relatively short half-life.”
In June 2018, Insys published Phase 1 results for the epinephrine nasal spray demonstrating similar bioavailability for the intranasal formulation compared to intramuscular epinephrine. The epinephrine nasal spray for the treatment of anaphylaxis received fast track designation from the FDA in August 2018.
After announcing in April 2018 that it would begin a clinical program for a dronabinol product based on the VOKE inhaler, which Insys licensed for use with cannabinoid products in 2015, the company said that its dronabinol inhaler “successfully completed” a Phase 1 study in September 2018. Insys also said that it plans to hold an advisory board meeting in the first quarter of 2019 “to discuss the development path going forward for this investigational product concept.”
Read the Insys Therapeutics press release.
