Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)
FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings
The Intermezzo(R) NDA follows the successful completion of two Phase 3 clinical trials. The first Intermezzo(R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. Results from the study demonstrated that the Intermezzo(R) 1.75 mg and 3.5 mg doses, when used at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo, with no evidence of next day residual sedative effects with either dose. Further, when patients used the 3.5 mg dose, the study also indicated statistically significant improvements in total sleep time, sleep efficiency, subjective number of post-dose awakenings, sleep quality, level of refreshed sleep, and next day ability to function. Transcept believes that these are the lowest zolpidem doses that have been reported to be statistically superior to placebo in producing sleep.
The second Phase 3 clinical trial was a double-blind, placebo-controlled outpatient study in which 294 patients used either Intermezzo(R) 3.5 mg or placebo at home, at the time they awakened in the middle of the night and had difficulty returning to sleep. This Phase 3 clinical trial also met its primary endpoint of significantly reducing the time required for the patient to return to sleep versus placebo. After dosing and returning to sleep, patients in the outpatient study who were randomized to Intermezzo(R) also reported fewer subsequent awakenings and less time awake during the remainder of the night. There was no evidence of next day residual sedative effects after middle of the night use of Intermezzo(R) versus placebo.
About Transcept Pharmaceuticals
Transcept Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the fields of psychiatry and sleep medicine. The lead Transcept product candidate, Intermezzo(R), is a sublingual low dose formulation of zolpidem that has been developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. Intermezzo(R) Phase 3 clinical trials have been completed and, on
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Additional Information About the Transcept Novacea Merger and Where to Find It
Novacea and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from its stockholders in favor of the proposed transaction. Information about the directors and executive officers of Novacea and their respective interests in the proposed transaction is available in the proxy statement/prospectus/information statement.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Transcept and Novacea disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the expected timing of potential U.S. Food and Drug Administration (FDA) approval of Intermezzo(R); and the expected timing of commercialization and launch of Intermezzo(R); and the expected benefits of Transcept product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, failure of Novacea stockholders to approve the merger; Novacea or Transcept inability to satisfy the conditions of the merger, or that the merger is otherwise delayed or ultimately not consummated; the rates of use of Transcept and Novacea cash and cash equivalents prior to the closing of the merger; positive results in clinical trials may not be sufficient to obtain FDA approval; physician or patient reluctance to use Intermezzo(R), if approved; potential alternative therapies; maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; and other difficulties or delays in, or unexpected expenses incurred in connection with, obtaining regulatory approval, market acceptance and commercialization of Intermezzo(R).
Intermezzo(R) is a registered trademark of Transcept Pharmaceuticals, Inc.
Contacts: Transcept Pharmaceuticals, Inc. Michael Gill Director of Communications (510) 215-3575 The Ruth Group Investors / Media Stephanie Carrington / Jason Rando (646) 536-7017 / 7025 email@example.com firstname.lastname@example.org
SOURCE Transcept Pharmaceuticals, Inc.