Indiplon

Indiplon
On February 18, 2004 Neurocrine Biosciences said that preliminary results from a late-stage clinical trial showed that its experimental sleeping pill, being developed in conjunction with Pfizer, works in elderly patients with chronic insomnia. Results from its Phase III clinical trial with two doses (5 mg and 10 mg) of the immediate release formulation of indiplon achieved statistically significant results in elderly patients with chronic insomnia. Results of the primary endpoint for this study, Latency to Sleep Onset (LSO) or the amount of time it took patients to fall asleep as measured by patient self reported outcomes, was statistically significant for both doses (p<0.02 at 5 mg and p<0.005 at 10 mg) as compared to placebo. For LSO, the time to sleep was shortened by more than 27 minutes for both indiplon doses, more than a 40% reduction from baseline. Sleep quality was significantly improved (p<0.005) at both dose levels as compared to placebo. Results confirmed that elderly patients with chronic insomnia who took indiplon fell asleep more rapidly and stayed asleep longer with fewer awakenings and reported improved sleep quality. Additionally, indiplon immediate release was well tolerated and there were no serious treatment-related adverse events reported in the study.

Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. There are two formulations of indiplon: immediate release and modified release. Both formulations are being studied in clinical trials to address different types of sleep problems. Insomnia is a prevalent condition in the United States, with nearly one-half of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35% of the adult population reports that they have experienced insomnia every night or almost every night within the past year. According to some analysts, the $2 billion market for sleep disorder drugs could eventually rise to $3 billion. However, we feel that existing approved therapies like Sanofi’s AmbienR, and King’s SonataR, combined with the promise of imminent new treatments like Sepracor’s Estorra™, make the insomnia marketplace a competitive one.

If approved, we feel indiplon will represent a Moderate Impact Technology, and recommend no early assessment activities at this time.

Technology Details
Target Disease / Indication: Insomnia
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Psychiatry
Regulatory Status: Phase III
BioHorizon Impact Score: 54/100 – Moderate