Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo® New Drug Application Following Meeting with the U.S. Food & Drug Administration
Press Release Source: Transcept Pharmaceuticals, Inc. On Wednesday September 14, 2011, 4:05 pm
POINT RICHMOND, Calif., Sept. 14, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT - News) announced today its plan to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
The plan to resubmit the Intermezzo® NDA results from a meeting today with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo® should only be taken if patients have at least 4 hours of bedtime remaining, and that patients should refrain from driving for at least 1 hour after arising and until 5 hours after dosing Intermezzo®.
Based on discussion with the FDA, Transcept does not plan to conduct additional studies prior to the resubmission of the Intermezzo® NDA and expects to resubmit the Intermezzo® NDA by the end of September 2011. The FDA has informed Transcept that if the planned resubmission is adequately concise in summarizing morning zolpidem levels and evidence that the levels are safe given the proposed labeling, it may be able to consider the resubmission as a two-month, Class 1 review under FDA guidelines. Transcept can provide no assurance that the resubmission will be reviewed by the FDA as a Class 1 resubmission or that the content of the resubmission will be sufficient to support approval of Intermezzo®.
Glenn A. Oclassen, President and Chief Executive Officer of Transcept, stated "We are pleased that the FDA has expressed general agreement with our proposal to address the concerns expressed in the July 2011 Intermezzo® Complete Response Letter. We look forward to working with the FDA to complete the review of this important new treatment strategy for insomnia characterized by middle of the night awakening.
surf's up......crikey
