Patient-Controlled, Needle-Free Fentanyl System Gets Green Light
The FDA has approved Ionsys.
Officials with The Medicines Company announced that the Food and Drug Administration has approved Ionsys (fentanyl iontophoretic transdermal system) for the short-term management of acute post-operative pain in adults requiring opioid analgesia in the hospital. Ionsys is the first needle-free, patient-controlled pre-programmed fentanyl delivery system to be approved.
Ionsys, a CII controlled substance, allows patients to control their analgesic dosing by pushing a button to administer fentanyl transdermally via an imperceptible electrical current as needed for pain. Ionsys contains fentanyl, an opioid analgesic that interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in human brain, spinal cord, and other tissues.
The efficacy of Ionsys was demonstrated in three placebo-controlled trials. The safety of Ionsys was established in three placebo-controlled trials and four additional active-controlled randomized trials.
Ionsys can only be dispensed to patients in hospitals enrolled in the Ionsys Risk Evaluation Mitigation Strategy (REMS) program; it is not intended for home use. Ionsys is expected launch in the third quarter of 2015.