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TransOral Pharmaceuticals, Inc. Changes Name to
Transcept Pharmaceuticals, Inc.
Pt. Richmond, Calif. June 22, 2007: TransOral Pharmaceuticals,
Inc., a specialty pharmaceutical company focused on deriving
significant new patient benefits from proven CNS drugs, today
announced that the company’s shareholders and Board of Directors
have approved a name change to Transcept Pharmaceuticals, Inc.
“The change from TransOral to Transcept solidifies our position
as a specialty pharmaceutical company and underscores our
strategy of developing and marketing improved and novel uses for
proven CNS drugs,” said Glenn A. Oclassen, President & Chief
Executive Officer. “Transcept modifies the performance of
existing active agents to provide new patient benefits and
indications. This strategy is exemplified by our lead product
Intermezzo™ which we are developing for the treatment of middle
of the night insomnia. Another example is TO-2060, a fixed
combination product under development for the treatment of
alcohol dependence and other dopamine-mediated psychiatric
disorders.”
Transcept is currently developing Intermezzo™ as a low dose,
fast acting prescription sleep aid for insomnia patients who
awaken in the middle of the night and have difficulty returning
to sleep. Intermezzo™ employs the company's proprietary
Bimucoral™ technology in a mint-flavored, sublingual lozenge
formulated to dissolve under the tongue in approximately two
minutes.
Clinical studies have demonstrated that Intermezzo™ employs the
lowest dose of zolpidem ever shown to be effective in inducing
sleep. Until recently, zolpidem has only been available in the
U.S. as the active agent in Ambien® and Ambien CRTM, prescribed
in adults at 10 mg and 12.5 mg doses respectively. A recent
Phase 3 sleep laboratory study for Intermezzo™ at doses of 3.5
mg and 1.75 mg demonstrated positive and highly statistically
significant results in adult insomnia patients experiencing
middle of the night insomnia.
Oclassen continued, “We have successfully completed the first of
two pivotal trials of Intermezzo™ and the second Phase 3 study,
an outpatient trial, is currently underway. Transcept expects to
file the Intermezzo™ NDA with the US Food and Drug
Administration before the end of 2008. In addition, we are also
conducting a clinical proof of concept trial of TO-2060 for the
treatment for alcohol dependence.”
TO-2060 is a novel fixed combination product employing low doses
of olanzapine and ondansetron that is being evaluated for the
treatment of alcohol dependence and other dopamine associated
psychiatric disorders. Current medications for alcohol
dependency have only modest efficacy. As more efficacious
treatments are developed it has been projected that this
market’s growth potential is one of the largest in the CNS drug
category.
Oclassen concluded, “Intermezzo™ and TO-2060 provide Transcept
with a core product foundation that will enable the company to
continue its development as a specialty pharmaceutical company.
We are proud of our progress thus far and look forward to even
greater success as Transcept.”
About Transcept Pharmaceuticals
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical
company developing novel formulations of proven CNS agents to
provide meaningful new patient benefits. Transcept priority
projects include the development of products for insomnia and
alcohol dependence. For more information, please visit
www.transcept-pharma.com.
Source:
Transcept Pharmaceuticals, Inc.
Investors and Media:
Michael Gill
Director of Communications
510.215.3575
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