Arena Pharmaceuticals, Inc. (ARNA)

[CrocHntr]

In the case of lorcaserin, the FDA might impose a REMS to try to limit off-label use.

I still don't understand why a REMS would be required? If not safety concerns, wouldn't any risk of using in conjunction with phentermine be a labeling issue only? Lorcaserin is a mono-therapy drug and was never planned to be used in conjunction with other medications.

Why would a REMS get imposed on Arena for something that would be handled on the labeling? If there's an issue with phentermine specifically, shouldn't that drug go through a REMS instead of lorc? FDA can't possibly sit around and try to think up a REMS for every single drug that might possibly be used in conjunction with lorcaserin.

To me, if lorcaserin is proven safe and effective as a mono-therapy, then any concerns with other drugs would part of a labeling issue at best.