Not depressed yet
One miss by Targacept, AstraZeneca doesn't predict fate of depression drug
If history is any guide, there's no reason to think the failure of Targacept Inc. and AstraZeneca plc's first flexible-dose Phase III trial of TC-5214 automatically means the program is dead. However, the partners probably will have to succeed in two of the remaining three depression trials to have a shot at approval. Two of those are fixed-dose studies - which some data suggest are less likely than flexible-dose studies to succeed.
Even among drugs that prove to be effective, subjective entry criteria and endpoints plus high placebo response rates in major depressive disorder (MDD) trials lead to high failure rates.
A meta-analysis published by FDAresearchers in April in the Journal of Clinical Psychiatry examined 81 efficacy trials testing antidepressants that were ultimately approved in the last 25 years. Only 53% of the studies showed a statistically significant difference from placebo. Most antidepressants thus experience at least one failure in Phase III testing.
This month, Targacept and AstraZeneca joined that club. The partners reported that in the flexible-dose, European Phase