The Medicines Company announced that the Food and Drug Administration (FDA) 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.

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The efficacy of Ionsys was demonstrated in 3 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.

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