Incline Therapeutics

IONSYS is a compact, needle-free, and disposable patient-controlled analgesia (PCA) system. It is designed to be worn on the skin of the upper arm or chest and allows patients to self-administer a 40-microgram dose of fentanyl transdermally by pressing a button. An imperceptible electrical current then delivers the opioid analgesic over a 10-minute period. The system was developed as an alternative to traditional intravenous PCA methods, aiming to offer greater patient mobility. The product had a complex history; it was initially approved by the FDA and EMA in 2006 but was later voluntarily recalled from the European market due to device stability issues and was never launched in the US at that time. Incline was formed to address these challenges and bring the improved product back to market.

In December 2012, The Medicines Company announced its agreement to acquire Incline Therapeutics for an upfront payment of $185 million, plus potential milestone payments. The acquisition was completed in January 2013, with Incline becoming a wholly-owned subsidiary of The Medicines Company. Under The Medicines Company, IONSYS received FDA approval in April 2015 and European Commission marketing authorization in November 2015 for the short-term management of acute post-operative pain in a hospital setting. However, due to business reasons, The Medicines Company voluntarily discontinued the sale and distribution of IONSYS in June 2017.