Washington Editor

Neurocrine Biosciences Inc.'s first Phase III study of indiplon-IR capsules in sleep initiation ended in success, leading the company to focus on the remaining seven trials it intends to complete in order to file a new drug application late next year.

Paul Hawran, executive vice president and chief financial officer of San Diego-based Neurocrine, told BioWorld Today that the 593-patient trial hit its endpoints, including a primary endpoint of latency to persistent sleep measured by polysomnography and a secondary endpoint of latency to sleep onset (LOS).

The company said indiplon-IR (immediate release) demonstrated a statistically significant improvement in the LPS at dose levels of 10 mg and 20 mg relative to placebo (p<0.0001). Mean improvements over placebo were approximately 36 percent and 50 percent for the 10-mg and 20-mg dose groups, respectively. The secondary efficacy endpoint of patient-reported LOS also demonstrated statistically significant improvements in the drug groups as compared to the placebo group (p<0.0001), indicating that the indiplon-IR participants felt that they fell asleep more rapidly, supporting the results demonstrated through polysomnography.

In response, Hawran said, "We're excited about the results of the Phase III trial and look forward to completing the remaining trials and filing the NDA."

Indeed, Dennis Harp, of Deutsche Bank Securities Inc. in New York, released a report saying peak sales of indiplon (a trade name has not been selected) could reach in excess of $1 billion worldwide. Others say indiplon's safety and efficacy data could help it capture much of the insomnia market.

Neurocrine believes it will have all data prepared and ready for filing late next year in both the immediate-release and modified-release (MR) formulations, meaning the company could launch indiplon in late 2004 or early 2005.

The company expects to partner the product, Hawran said.

Meanwhile, the next set of Phase III data is expected to be public in the first quarter, said Hawran, who added that Neurocrine is conducting eight trials "in order to differentiate ourselves and our compound from other currently marketed products."

All told, the Phase III trials are expected to enroll 4,000 people.

Study results released Thursday show that indiplon-IR helped participants achieve rapid sleep induction without next-day residual effects. The Phase III was a randomized, double-blind, placebo-controlled, parallel-group study specifically designed to assess safety and efficacy of two dose levels in adults with transient insomnia (people who occasionally have problems falling asleep).

The other ongoing trials include four IR Phase III studies and three MR Phase III trials. Hawran said indiplon-IR is a short-acting sedative that helps a person fall asleep quickly, while the MR formulation helps the person achieve sleep maintenance or improve the quality of the sleep.

Indiplon (formerly NBI-34060) is a non-benzodiazepine that acts on a specific site of the GABA-A receptor.

Neurocrine's stock (NASDAQ:NBIX) closed Thursday at $48, up $1.71.