Neurocrine Biosciences, Inc. has submitted a New Drug Application (NDA) to the US FDA for regulatory approval of indiplon modified release tablets for the treatment of insomnia. The application contains safety and efficacy results from 8 phase III clinical trials with indiplon modified release conducted in adult and elderly patients with transient and chronic insomnia. The NDA for indiplon immediate release capsules was submitted to the FDA on October 18 of this year.
This NDA submission contains manufacturing and clinical information specific to the modified release formulation. The first NDA submitted in October for indiplon immediate release included non-clinical, clinical, and manufacturing information that was common to both applications. The NDAs have been submitted in electronic common technical document format (e-CTD) and include data from a comprehensive safety and efficacy evaluation in over 7500 subjects.
"Patients with insomnia experience a wide range of symptoms such as trouble falling asleep, trouble staying asleep, and waking up frequently during the night. However, no two patients are alike as symptoms vary from patient to patient. The two formulations of indiplon will be an important advance in allowing physicians to tailor treatment to help improve patients' individual insomnia symptoms and, as a result, sleep quality. Clinical trials consistently showed that patients fell sleep quickly and stayed asleep longer when modified release tablets were taken at bedtime," said Dr. Thomas Roth, director, Sleep Disorders Centre, Henry Ford Hospital.
"The submission of the two NDAs for indiplon represents a great achievement for Neurocrine that will turn the focus of the Company towards commercialization. We are now moving forward with our partner, Pfizer, in preparing for the commercialization of indiplon, while building and training the Neurocrine sales force to co-detail Zoloft with Pfizer to psychiatrists," said Gary A. Lyons, president and CEO of Neurocrine Biosciences.
Indiplon, a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor, was licensed from DOV Pharmaceutical in 1998.