IntermezzoTreatment for Insomnia
Update: Intermezzo (zolpidem tartrate sublingual tablets) Now FDA Approved - November 23, 2011
Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment of Middle of the Night Awakenings
POINT RICHMOND, Calif., Jan. 18, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
Transcept expects that the Intermezzo NDA resubmission, if accepted and deemed complete by the FDA, will be subject to a Class 2 six-month review.
The Intermezzo resubmission package is intended to address issues raised in the October 2009 FDA Complete Response Letter. New information contained in the resubmission package includes data and analyses from the recently completed Intermezzo highway driving study, a comparative review of data from previous driving studies of sleep aids and other medications, and redesigned product packaging and instructional tools. The resubmission also includes a recent epidemiology study that demonstrates the widespread use of 7 to 8 hour hypnotic drugs in the middle of the night, despite the fact that these products have been approved only for bedtime dosing.
"If approved, we anticipate that Intermezzo will be the first prescription sleep aid for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep," said Glenn A. Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals. "We plan to work closely with the FDA through the resubmission process and are fully committed to making this important therapeutic option available to insomnia patients."
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. The most advanced Transcept product candidate is Intermezzo (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) in January 2011 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Transcept and Purdue Pharmaceutical Products L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo in the United States. Transcept is also developing Setrodon™, an ultra low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with SSRIs. Transcept plans to begin a Phase 2 study of Setrodon™ in early 2011.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include our expectation that the Intermezzo NDA resubmission will be accepted and deemed complete by the FDA for a Class 2 six month review; the sufficiency of the Intermezzo NDA resubmission to satisfy FDA issues and warrant approval of Intermezzo for use in its intended indication; plans regarding Transcept commitment to Intermezzo and Setrodon™ development; and plans to begin a Phase 2 study of Setrodon™ in 2011. Transcept may not actually meet these expectations and carry out these plans. Various important factors that could cause actual events to differ materially from the forward-looking statements that Transcept makes, include FDA deemed insufficiencies in the Intermezzo NDA resubmission package; dependence on third parties to manufacture Setrodon™ and carry-out the planned Phase 2 study of Setrodon™; success in our efforts to seek approval for Intermezzo ®; and the business of Transcept generally. These and other risks are described in greater detail in the "Risk Factors" section of Transcept periodic reports filed with the Securities and Exchange Commission. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments Transcept may enter into or make. Transcept does not assume any obligation to update any forward-looking statements, except as may be required by law.
Posted: January 2011
- FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep - November 23, 2011
- Transcept Pharmaceuticals Announces Intermezzo PDUFA Action Date of November 27, 2011 - October 7, 2011
- Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration - September 14, 2011
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - July 15, 2011
- Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo New Drug Application Based on Teleconference with FDA - July 13, 2011
- Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA - March 25, 2010
- Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review - February 23, 2010
- Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter - November 24, 2009
- Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - October 30, 2009
- Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo - June 11, 2009
- Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo - December 16, 2008
- Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings - October 1, 2008