Locaserin trial passes 1-year safety review

The USA's Arena Pharmaceuticals is continuing a pivotal Phase III trial of its obesity drug locaserin HCl, after a go ahead from its independent Echocardiographic Data Safety Monitoring Board. The review of unblinded echocardiographic data performed after patients completed 12 months of dosing in the trial confirmed that differences, if any, in the rates of Food and Drug Administration-defined valvulopathy in lorcaserin patients and in the control group did not meet the EDSMB's predetermined stopping criteria.

Locaserin's progress is being closely watched as it is similar to Wyeth's diet drugs Pondamin (fenfluramine) and Redux (dexfenfluramine) - often referred to collectively fen-phen - which were withdrawn in 1997 after allegations that they had caused damage to heart valves in some patients (Marketletters passim). The products cost the US drug major over $1.27 billion in patient litigation.

"This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin's cardiovascular safety profile. We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine-like effect on heart valves if present. The BLOOM study's primary echo endpoint is based on the month-12 data," said Jack Lief, Arena's chief executive.