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2011 Scrip 100: CNS trials

This article was originally published in Scrip

Executive Summary

In the CNS therapeutic area, 303 industry-sponsored Phase II and Phase III trials were initiated between 1 October 2009 and 30 September 2010. Phase II and Phase III trial starts were equally split, with continuing high interest in pain. Nociceptive pain had more new Phase II starts (27) and total initiated trials (54) than any other indication. Neuropathic pain ranked next in terms of trial starts (32) and nearly half of these targeted pain caused by diabetic neuropathy. Combining trials for both nociceptive and neuropathic pain symptoms, pain relief represented nearly one-third of total trial starts, reflecting a continuing industry trend of yearly R&D expenditure in this competitive area. Depression and multiple sclerosis followed pain as areas of steady interest. In depression, 21 of 31 trials were Phase III starts, most aimed at drug registration. These included Lundbeck's LuAA21004 and AstraZeneca's TC-5214, with both companies planning to file new drug applications in 2012. Trials initiated in MS remained high despite the recent approval of the first oral medication, FTY720. Phase II schizophrenia trials targeted cognitive dysfunction, while Phase III trials aimed at new oral formulations for approved drugs. Alzheimer's disease trials were overwhelmingly Phase II (16 of 22 trials), reflecting the difficulty in demonstrating significant efficacy in large Phase III studies, as seen in the failure of both the histamine receptor antagonist Dimebon and the secretase gamma inhibitor LY450139 programmes. Parkinson's disease, with 17 of 20 trial starts in Phase III, showed robust pipeline advancement in this area.

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