Neurocrine Resubmits Immediate-Release Indiplon
This article was originally published in The Pink Sheet Daily
Executive Summary
Sleep aid could at last reach market late in 2008.
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Neurocrine Biosciences has resubmitted its NDA for indiplon immediate-release capsules for the treatment of insomnia in both adult and elderly patients as a complete response to a May 2006 FDA "approvable" letter, the firm announced June 12. Neurocrine CEO Gary Lyons noted during the company's first-quarter earnings call May 3 that a reanalysis of previously submitted data requested by FDA was complete and that Neurocrine was on track to resubmit the NDA for indiplon in 5 mg and 10 mg strengths by the end of the second quarter. If FDA accepts the resubmission and gives it a six-month (Class 2) review, approval could come by the end of 2007, making a late 2008 launch possible. Neurocrine said the submission is "based on analyses discussed with statistical, clinical and regulatory consultants" in addition to "interactions with the FDA." The San Diego-based company originally submitted the indiplon IR application in 2004, but FDA rejected the NDA because of formatting concerns related to electronic submission. The company then re-filed indiplon IR in April 2005, roughly in parallel with a separate NDA for an extended-release formulation. But in May 2006, after extending the review time on both NDAs, FDA deemed the IR application "approvable" and the ER application "not approvable" (1 (Also see "FDA’s Mixed Response To Indiplon Is Pfizer/Neurocrine’s Rude Awakening" - Pink Sheet, 16 May, 2006.)). Since then, the firm has concentrated its indiplon efforts on gaining approval for the instant release capsules. During an earnings call in November, Lyons said the company had altered a three-month study planned to support the ER application to instead produce additional data in support of indiplon IR (2 (Also see "Neurocrine Delays Indiplon Resubmission To Run Confirmatory Trial" - Pink Sheet, 3 Nov, 2006.)). However, Neurocrine anticipates pursuing a sleep maintenance indication for both formulations, and studies to support an independent ER application are planned, Lyons said. The sleep aid space has seen significant changes since Neurocrine first filed for approval of indiplon. Takeda's Rozerem (ramelteon) was approved in July 2005 without controlled substance scheduling, a claim Neurocrine has hoped to make for indiplon. Indiplon is a non-narcotic, non-benzodiazepine agent that "has been shown to bind more selectively to the specific subtype of GABA-A receptors" that promote sleep, according to Neurocrine. In addition, generics of Sanofi-Aventis' Ambien (zolpidem) became available in April of this year, providing increased competition for branded Ambien as well as for the likes of Sepracor's Lunesta (eszopiclone), King's Sonata (zaleplon) and Rozerem (3 (Also see "Ambien Generics Grab 5 Percent of Insomnia Market In First Week" - Pink Sheet, 7 May, 2007.)). Neurocrine likely will need a new commercialization partner to succeed in the crowded market after Pfizer dropped out of a development deal in June 2006, returning all rights to Neurocrine. In a June 13 note, Bear Stearns analysts Akhtar Samad, Arlinda Lee and Vinay Thapar acknowledge that Neurocrine will require an indiplon partner, adding that "a potential partner may await FDA approval to alleviate risk." - Shirley Haley ([email protected]) |