ITI Announces New Progress Milestones In Its Development Program For Acute Repetitive Seizure In Epilepsy

Main Category: Epilepsy
Article Date: 10 Dec 2008 - 6:00 PDT

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ITI, a privately held specialty pharmaceutical company, today announced that the company has achieved several important developments in its epilepsy product program, including

- Receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) in October 2008 for ITI's product candidate ITI-111

- Completion of an end of Phase 2 meeting with the FDA in November 2008; and

- Plans to initiate Phase 3 trials for ITI-111 in the first half of 2009.

ITI-111 employs a novel, nasally administered formulation of midazolam, a long-established benzodiazepine, which is intended to treat epileptic patients who experience episodic seizure clusters, sometimes referred to as acute repetitive seizures.

"It's very exciting to see the progress that this development program has made this year," Jeff Edelson, MD, Executive Vice President of R&D and Chief Medical Officer, commented. "Fast Track status recognizes the importance of this target medical need and the potential of this product to alleviate it. The end of Phase 2 meeting builds on our highly efficient clinical trial effort over the course of the year and the extensive clinical literature on the use of nasally administered midazolam in epilepsy. Most importantly, the outcome of this meeting has provided a clearly defined pathway to Phase 3 trials and an NDA submission."

Part of the FDA Modernization Act of 1997, fast track designation is designed to facilitate the development and expedite the review of new drugs for the treatment of serious or life-threatening conditions by providing frequent dialogue with FDA reviewers and timely review of submissions to the agency, although not a guarantee of approval or expedited review.

"Epilepsy patients who experience this pattern of seizure need treatment that can be used in an outpatient setting, which ideally allows them to resume their normal activities as soon as possible," observed Dr. Jacqueline French, Professor of Neurology at New York University. "There is a need for additional therapeutic options for many of these patients, and these recent developments are a clear indication of the potential importance that midazolam nasal spray and other acute therapies may have in this field." Dr. French has been a consultant for ITI, but has not received personal compensation from the company.

Clinical experts and published literature suggest a varying number of patients with epilepsy in the United States suffer from this pattern of seizure, with a mid-point estimate of around 90,000. A rectally administered gel is currently approved for the treatment of acute repetitive epileptic seizure on an outpatient basis.

About ITI

ITI is a specialty pharmaceutical company focused on developing innovative specialty pharmaceutical products, with an emphasis on drugs in specialized therapeutic areas for which there is proven, unsatisfied medical and patient need. The company currently has several significant products in its clinical development pipeline or in formulation and preclinical development. ITI's goal is to become a leader in the field of specialty pharmaceuticals by applying formulation and development expertise across selected therapeutic areas to create new and differentiated products that improve safety, efficacy and convenience for patients, caregivers and health care professionals.

http://www.intranasal.com