WASHINGTON (dpa-AFX) - Arena Pharmaceuticals, Inc.(ARNA) Tuesday said it has submitted additional data with the U.S. Food and Drug Administration related to its obesity drug candidate lorcaserin. The move was in response to the Complete Response Letter issued by the agency, following a review of Arena's New Drug Application for lorcaserin.
Arena's NDA for lorcaserin was submitted in December 2009, but was turned down by the FDA in October 2010.
Arena and its marketing partner for lorcaserin Eisai Inc. said they have provided the FDA with data not included in the original NDA, including results from the Phase 3 BLOOM-DM trial that evaluated the drug candidate for weight loss in patients with type 2 diabetes. As well, the information to FDA includes details of a two-year lorcaserin rat carcinogenicity study, related to concerns of tumor in rats following lorcaserin tests.
The company had completed a study for determining the human relevance of the observation of brain astrocytoma in male rats. It was indicated that the exposure of the human brain to lorcaserin was far lower than the measured exposure of the male rat brain to lorcaserin.
Among other data forwarded to the FDA includes cell culture experiments intended to further refine serotonin subtype 2 receptor activity and rat studies designed to further assess abuse potential.
Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism.
ARNA closed Tuesday's regular trade at $1.92, up $0.05 or 2.67%, on the Nasdaq. In the after hours, the stock gained $0.21 or 10.94%.
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