Neurocrine's insomnia drug clears Ph II trial

Neurocrine Biosciences has reported positive results from a Phase IItrial of NBI-34060, a non-benzodiazepine GABA A receptor agonist, as a treatment for patients with chronic insomnia. The 59-patient study found that NBI-34060 achieved a significant improvement in the time to sleep onset (latency to persistent sleep), the primary endpoint of the trial, as well as secondary endpoints such as total sleep time and sleep efficiency.

LPS was improved by up to 46% in patients treated with NBI-34060, with a significant improvement over placebo at all doses tested, and 80% of those receiving the drug fell asleep within 30 minutes. There were no clinically-relevant incidences of residual effects of NBI-34060 on the day after treatment, as measured by standard tests of sedation, and the drug was safe and well-tolerated, according to the company. The drug has been designed to exclude the side effects associated with benzodiazepine therapy.

"Based on these positive safety and robust efficacy results, Neurocrine will select final doses for pivotal Phase III clinical studies with NBI-34060, which are expected to start in the fourth quarter of this year," said the firm. The drug has already shown activity in trials involving patients with transient insomnia.