FDA letter asks for new indiplon trial
The US Food and Drug Administration has issued an "approvable letter" requesting additional preclinical and clinical data confirming the effectiveness of Neurocrine Biosciences' candidate insomnia drug, indiplon. The news, which followed re-submission of data from trials of 5mg and 10mg doses of the product, caused the California-headquartered firm's share price to plummet 45% to $5.65 in premarket trading on the Nasdaq on December 13.
Last year, the FDA said it would not clear the 15mg dose of indiplon, but added that the 5mg and 10mg strengths of the drug were approvable pending re-analysis and resubmission of supporting data (Marketletter May 22, 2006). However this decision led US drug giant Pfizer to hand back co-development rights, which observers at the time said was an indication of declining confidence in indiplon's market viability (Marketletter July 3, 2006).
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