PT. RICHMOND, Calif., June 22 /PRNewswire/ -- 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(TM), 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(TM) 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(TM) employs the company’s proprietary Bimucoral(TM) technology in a mint-flavored, sublingual lozenge formulated to dissolve under the tongue in approximately two minutes.
Clinical studies have demonstrated that Intermezzo(TM) 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(R) and Ambien CR(TM), prescribed in adults at 10 mg and 12.5 mg doses respectively. A recent Phase 3 sleep laboratory study for Intermezzo(TM) 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(TM) and the second Phase 3 study, an outpatient trial, is currently underway. Transcept expects to file the Intermezzo(TM) 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(TM) 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.
Transcept Pharmaceuticals, Inc.
CONTACT: Investors and Media, Michael Gill, Director of Communications,+1-510-215-3575
