Hospice Medication Alert: New Fentanyl Sublingual Spray Approved
Posted by Dr. Julia Harder
INSYS Therapeutics has announced FDA approval of SUBSYS fentanyl sublingual spray for the treatment of breakthrough cancer pain. SUBSYS is a single-dose sublingually-administered formulation of fentanyl that joins five other rapid-acting fentanyl products already on the market (Abstral, Actiq, Fentora, Lazanda and Onsolis). INSYS Therapeutics claims SUBSYS is the only transmucosal fentanyl product to show statistically significant pain relief when measuring the sum of pain intensity difference at five minutes in a Phase 3 clinical trial of breakthrough cancer pain.
SUBSYS will be launched under the recently approved Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access Program, which we will be discussing further on the blog next week. SUBSYS is expected to be available in the early part of this year.