The U.S. Food and Drug Administration approved the Medicines Co's drug device Ionsys for post-operative pain for hospital use, the company said on Thursday.
Ionsys, a needleless, patient-controlled, opioid-based treatment, offers patients recovering from surgery in the hospital control over their analgesic dosing.
Ionsys was originally developed by Johnson & Johnson and won approval in the United States and Europe in 2006. But after its launch in Europe in 2008, it was recalled due to device stability issues. The therapy never made it to the market in the United States.
The Medicines Co gained access to the product through its 2012 acquisition of Incline Therapeutics Inc, which had acquired the treatment from J&J in 2010. (bit.ly/1JTvQng)
The approval also cements Ionsys' lead over AcelRx Pharmaceuticals Inc's rival drug Zalviso, which is in development.
Zalviso was dealt another blow in March after the FDA said it required an additional study to evaluate risks associated with the device.
For more details, go to: http://www.reuters.com/article/2015/05/01/us-medicines-fda-idUSKBN0NL2VO20150501