SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced positive results from its Phase III trial with the modified release formulation of indiplon, achieving highly statistically significant results in adults with transient insomnia. The study was a randomized, double-blind, placebo-controlled, parallel-group, multi-center sleep laboratory Phase III clinical trial. The primary objective of the study was to assess the efficacy of two dose levels of indiplon modified release (20 mg and 30 mg) relative to placebo on sleep initiation in 325 healthy adult subjects. The primary endpoint for the study was Latency to Persistent Sleep (LPS), or time to sleep onset, as measured objectively by polysomnography (PSG). Indiplon modified release demonstrated a statistically significant reduction in LPS at both dose levels (p
"We are excited about the clinical results for our first Phase III clinical trial with indiplon modified release in transient insomnia. These results demonstrate the versatility of the modified release formulation and will enhance the data set for the modified release formulation with this new data on sleep initiation," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences.
This Phase III study was conducted in 11 centers in North America using a sleep laboratory model of the first night effect in a new environment combined with a phase advance (advancing subjects' bedtime 2 hours earlier than their normal bedtime) for the purpose of inducing transient insomnia in normal healthy adult volunteers who otherwise have a normal sleep pattern.
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 are being studied in clinical trials to address different types of sleep problems.
Source: Neurocrine Biosciences, Inc.