(Reuters) - The U.S. Food and Drug Administration approved the Medicines Co’s drug device Ionsys for postoperative 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. (bit.ly/1DCteVO)
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.
RBC Capital’s Adnan Butt said he expects Ionsys, which is also awaiting a regulatory decision in Europe, to generate worldwide peak sales of about a half a billion in 2022.
The New Jersey-based company said it expects Ionsys to be available in the U.S. in the third quarter.
Butt said any drug approval for the company “would be considered positive at this time” because of the uncertainty surrounding Medicine Co’s Angiomax, an anti-coagulant injection.
Earlier this month, the company estimated lower-than-expected revenue for the first quarter, and Chief Executive Clive Meanwell attributed the shortfall to a drop in Angiomax sales due to potential competition from generic versions.
Angiomax accounted for more than 80 percent of the company’s 2014 revenue of about $724 million.
The FDA also approved the company’s blood clotting agent Raplixa on Thursday.
Medicine Co.’s shares closed down 1.7 percent at $25.61 on the Nasdaq ahead of the news.
Reporting by Natalie Grover and Samantha Kareen Nair in Bengaluru; Editing by Leslie Adler