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Arena/ Eisai's lorcaserin shows efficacy

Weight loss drug lorcaserin, co-marketed by Arena and Eisai, has met efficacy goals in a phase III trial involving type 2 diabetes patients

Weight loss drug lorcaserin has met efficacy goals in a phase III trial involving obese and overweight patients with type 2 diabetes.

The drug, which is co-marketed by Arena Pharmaceuticals and Eisai following an agreement in July 2010,  met all three co-primary efficacy endpoints in the BLOOM-DM (Behavioural modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) study, with significant weightloss recorded in patients following a year's treatment.

The study compared  lorcaserin to placebo, with over 604 participants affected by type 2 diabetes involved. Lorcaserin is developed for weight management in obese or overweight patients with at least one ongoing weight-related condition.

Adverse effects recorded in the study included headaches, upper respiratory infection and backpain. Hypoglycaemia related effects were also reported by 29.3 per cent of patients taking lorcaserin 10mg BID, compared to 21.0 per cent of patients on placebo.  No events of severe hypoglycaemia were reported in either treatment group, however.

Earlier this year, the US Food and Drug Administration (FDA) rejected a new drug application (NDA) for lorcaserin filed by Arena, with the regulatory body citing insufficient evidence of efficacy, as well as safety concerns for its decision.

In its complete response letter denying approval for the drug, however, the FDA recommended that Arena submit the final study report of the BLOOM-DM trial.

Speaking on the potential effects of the trial results Jack Lief, president and CEO, Arena, said: "We look forward to reviewing the BLOOM-DM data with the FDA as the efficacy results are aligned with the agency's categorical benchmark for weight management."

9th November 2010

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