It is ridiculous that the panel should ask for Phentermine combo data. FDA advised against such combo study before Lorcaserin is approved according to Jack Leaf. We just got a cardiologist slamming Qnexa because of the increase in heart rate and they want a combo study with phentermine? Why not ask for a combo study of Lorcaserin + Topomax or Lorcaserin + Bluproprion or Lorcaserin + Orilstat? The panel even asked VVUS if its possible to take Topomax and Phertermine separately instead of combining the two. Jack Leaf was not lying when he said MDs would like to try single therapy first before moving into combos. Lorcaserin should be combined with GLP-1 instead of phentermine IMO.
Your concern with SSRi is fair. ARNA can propose Lorcaserin to be contraindicated in that population. If patients need to take SSRIs they can stop Lorcaserin. However, by the time a woman realizes she is pregnant, its too late to stop Qnexa. I would like to know how VVUS is going to address that concern even with a longer study.
VVUS - I think the FDA will go with the panel recommendation and ask for a CV outcomes study before approving. Risk with SSRI can be managed via label warning.
Are you referring to both the high and mid doses or perhaps just the mid dose? It seems that the majority of the discussions during the AC panel were centered around the high dose and perhaps VVUS should have tried to emphasize that the mid-dose was highly effective as well. Perhaps they did but after going through AF's blog it doesn't appear that way.
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