Arena endocrine news
Arena will reduce U.S. headcount by 66 (25%) to about 200 and said FDA requested additional studies for obesity candidate lorcaserin beyond what the agency asked for in a December meeting to discuss an October complete response letter. According to Arena, FDA expressed further concerns about lorcaserin's abuse potential and recommended that the company modify and repeat two non-clinical safety studies to provide more information on labeling and scheduling decisions. Arena plans to begin the studies pending a meeting with FDA's controlled substances staff in February.
Additionally, the agency asked Arena to conduct a 12-month study in female rats to test whether prolactin elevation mediated by short-term exposure to lorcaserin can result in mammary tumors in rats. Arena also said it will expand studies intended to characterize lorcaserin's activity at the serotonin (5-HT2C) receptor and assess the risk of valvulopathy, at FDA's request. Arena said it remains on track to resubmit an NDA to FDA for lorcaserin by the end of 2011 (see BioCentury, Nov. 1, 2010 & Jan. 3, 2011). ...