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Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative that was developed in 2 formulations - an immediate release product for sleep onset and a modified-release (a.k.a. controlled-release or extended-release) version for sleep maintenance.
Mode of action
Indiplon works by enhancing the action of the inhibitory neurotransmitter GABA, like most other nonbenzodiazepine sedatives. It primarily binds to the α1 subunits of the GABAA receptors in the brain.
Indiplon was originally scheduled for release in 2007, when Sanofi-Aventis' popular hypnotic zolpidem lost its patent rights in the United States and thus became available as a much less expensive generic. In 2002, Neurocrine Biosciences had entered into an agreement with Pfizer to co-market indiplon in the US, in a deal worth a potential $400mn. However, following the issuing of a non-approvable letter for the modified-release 15 mg formulation and an approvable letter with stipulations for the 5 mg and 10 mg immediate-release version by the FDA in May 2006, Pfizer ended its relationship with Neurocrine. Neurocrine's stock price dropped 60% on the news.
Following a resubmission, the FDA in December 2007 deemed Neurocrine's new drug application (NDA) 'approvable' in the 5 and 10 mg formulations, but requested new studies as a prerequisite to approval, including a clinical trial in the elderly, a safety study comparing adverse effects to those of similarly marketed drugs, and a preclinical study examining indiplon's safety in the third trimester of pregnancy.
- Petroski RE; Pomeroy JE; Das R et al. (April 2006). "Indiplon is a high-affinity positive allosteric modulator with selectivity for alpha1 subunit-containing GABAA receptors" (PDF). J. Pharmacol. Exp. Ther. 317 (1): 369–77. PMID 16399882. doi:10.1124/jpet.105.096701.
- San Diego's Neurocrine Biosciences Scores Second Big Deal in Two Days - The Motley Fool, 18 June 2010
- Neurocrine's FDA Nightmare - TheStreet.com, 16 May 2006
- Pfizer Drops Neurocrine Deal - TheStreet.com, 22 June 2006
- Neurocrine stock price plunges 60 percent:FDA's mixed review of sleeping pill Indiplon could threaten Pfizer-Neurocrine partnership - CNN Money, 15 May 2006
- "Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA" (Press release). Neurocrine Biosciences, Inc. 2007-12-13. Retrieved 2007-12-13.
- "Additional Pipeline Projects". Neurocrine. 2012-02-16. Archived from the original on 2012-02-20. Retrieved 2014-06-24.
- Neurocrine's drug pipeline page referencing indiplon
- 2004 press release announcing Neurocrine's new product, Indiplon
- GenomeNet Entry: D02640