The USA's Arena Pharmaceuticals says that its insomnia drug candidate APD125 missed the primary and secondary endpoints in a Phase IIb trial.
Treatment with APD125 was well tolerated, and there were no reports of serious adverse events and no emerging safety findings compared to placebo. Arena is finishing a complete analysis of the data, but does not anticipate developing it further.
"While we are disappointed and anticipated a different result based on objective polysomnographic results from our previous studies, our priority remains the successful development of lorcaserin, our proprietary investigative treatment for obesity. We expect to announce lorcaserin results from BLOOM, our first pivotal Phase III clinical trial, around the end of March and to file a New Drug Application for lorcaserin by the end of 2009," said Jack Lief, Arena's chief executive.
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