A New Drug Application (NDA) has been submitted by Neurocrine Biosciences Inc to the US Food and Drug Administration (FDA) for regulatory approval of indiplon immediate release capsules for the treatment of insomnia. The application contains safety and efficacy results from seven phase III clinical trials with indiplon immediate release conducted in adult and elderly patients with transient and chronic insomnia.
Neurocrine is developing two formulations of indiplon, an immediate release capsule and modified release tablet, for the treatment of multiple forms of insomnia. Neurocrine expects to submit a second NDA for indiplon modified release tablets in November. This first NDA submission contains non-clinical, clinical and manufacturing information that is common to both applications, the official statement said here.
The NDA has been submitted in electronic common technical document format (e-CTD). It includes data from a comprehensive safety and efficacy evaluation in approximately 3000 subjects.
"Insomnia affects over 85 million younger and older adults every year and is becoming more recognized by physicians as a disease that affects many aspects of patients' health and well-being. Indiplon capsules and tablets have consistently demonstrated robust efficacy and safety in repeated clinical evaluations, measuring multiple parameters of sleep difficulties. These results confirm that indiplon will offer physicians a significant improvement in the diagnosis and treatment of patients' individual sleep needs," said Dr. Thomas Roth, director Sleep Disorders Centre, Henry Ford Hospital.
"Indiplon capsules have consistently demonstrated that patients fall asleep faster, have improved sleep quality and sleep duration. Phase III safety and efficacy clinical trials have shown that indiplon capsules can be taken during the night for patients who suffer from night time awakenings and have been shown to be safe and effective for long term chronic usage. We are pleased to have Pfizer, the leading global pharmaceutical company, as our partner in the development and commercialization of indiplon," said Gary A Lyons, president and CEO of Neurocrine Biosciences.
Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon was licensed from DOV Pharmaceutical in 1998.
Neurocrine Biosciences Inc is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.