Neurocrine Biosciences (NBIX) said Thursday that results from the first late-stage study of its experimental sleeping pill proved the drug to be effective and safe in patients with transient insomnia.
Results from the 593-patient, phase III clinical trial demonstrated that a capsule formulation of the drug Indiplon allowed people to fall asleep quickly without feeling drowsy the following day. The study achieved statistically significant results in both its primary and secondary endpoints, which used machines to measure objectively the onset and quality of a person's sleep.
In addition to this study, Neurocrine is currently conducting four additional phase III clinical trials with the capsule formulation of Indiplon and three phase III trials with a tablet form of the drug. The studies will be used to eventually support an approval application for multiple indications associated with insomnia.
If approved, Indiplone will compete against prescription sleeping pills such as Ambien, which is marketed by Sanofi-Synthelabo (SNY).Neurocrine is expected soon to hammer out a comarketing deal with a major pharmaceutical maker. Shares of Neurocrine closed Wednesday at $46.29.