ARTICLE | Company News

CHMP backs Twynsta, reviews modified-release opioids

July 24, 2010 12:45 AM UTC

The European Medicines Agency's CHMP issued a positive opinion on an MAA from Boehringer Ingelheim GmbH (Ingelheim, Germany) for Twynsta telmisartan/amlodipine to treat hypertension. Twynsta, which is already approved in the U.S., is a combination of telmisartan, a small molecule angiotensin II receptor and amlodipine, a calcium channel blocker.

The EMA committee also recommended suspending marketing authorizations of oral opioids using polymethacrylate-triethylcitrate controlled-release systems over concerns of interactions with alcohol. The decision comes following a review of modified-release oral opioids classified at the level III scale by the World Health Organization (WHO). For all other drugs in the class, CHMP concluded the benefits outweigh their risks. ...