Transcept Pharmaceuticals Announces that a Phase 2 Clinical Trial of TO-2061 as Adjunctive Therapy for Obsessive Compulsive

 Transcept Pharmaceuticals Announces that a Phase 2 Clinical Trial of TO-2061
 as Adjunctive Therapy for Obsessive Compulsive Disorder Did Not Meet Primary
                                   Endpoint

PR Newswire

POINT RICHMOND, Calif., Dec. 21, 2012

POINT RICHMOND, Calif., Dec. 21, 2012 /PRNewswire/ -- Transcept
Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced initial top-line results
from its Phase 2 clinical trial evaluating the efficacy and safety of TO-2061
(ondansetron oral tablets 0.5 mg and 0.75 mg) in patients with obsessive
compulsive disorder (OCD) who had not adequately responded to treatment with
approved first-line therapies. The data from the trial showed that TO-2061 did
not meet the primary efficacy endpoint to demonstrate an improvement in OCD
symptoms versus placebo.

Transcept expects to complete the remaining protocol-specified analyses in
early 2013 and will make a determination on any future development of TO-2061
after further review of the data.

"It is disappointing that the Phase 2 trial of TO-2061 did not meet its
primary endpoint, in particular for those patients suffering from treatment
resistant OCD," said Glenn Oclassen, President and Chief Executive Officer of
Transcept. "Once we have reviewed the full data set, we will determine next
steps, if any, in the clinical development program for TO-2061 for the
adjunctive treatment of OCD."

About the Study Design

The Phase 2 study was a double-blind, placebo-controlled trial to evaluate the
safety and efficacy of TO-2061 in 168 OCD patients who had not adequately
responded to an approved OCD medication. Patients with a documented history of
at least 6 weeks of inadequate response to an approved OCD medication
continued to receive that first line OCD medication during an additional
6-week run-in phase of the study.Those patients who failed to respond during
the run-in phase were eligible to be randomized to the 12-week double-blind
active treatment phase, during which they continued to receive their first
line medication with the addition of ondansetron 0.5 mg twice per day,
ondansetron 0.75 mg twice per day or placebo twice per day. The primary
endpoint of the study was the difference between active and placebo treatment
arms in the change from baseline as measured by the Yale-Brown Obsessive
Compulsive Scale (Y-BOCS). The Y-BOCS is a ten-item clinician-administered
scale used to assess the severity of obsessions and compulsions, independent
of the number and type of obsessions or compulsions present.

About TO-2061

TO-2061 is an investigational drug designed as an adjunctive treatment for use
with approved OCD medications. TO-2061 is a low dose formulation of
ondansetron, a serotonin subtype 3 (5-HT3) receptor antagonist, that has been
approved for the treatment of nausea and vomiting caused by chemotherapy and
radiation therapy, and for the prevention of postsurgical nausea and vomiting.
Ondansetron has an established history of clinical use as a safe and effective
treatment at a typical daily dose of 16 mg to 24 mg. In the Phase 2 trial,
TO-2061 was studied at total daily doses of 1 mg to 1.5 mg.

About Transcept Pharmaceuticals

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. Intermezzo®
(zolpidem tartrate) sublingual tablet C-IV is the firstFDAapproved Transcept
product.PurduePharma holds commercialization and development rights for
Intermezzo in the United States. For further information about Transcept,
please visit www.transcept.com. For information about Intermezzo, please visit
www.IntermezzoRx.com.

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 regarding our strategy,
future operations, future financial position, future revenues, projected
expenses, prospects, plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not limited to,
statements relating to the following: the determination of next steps, if
any, in the clinical development program for TO-2061 for the treatment of OCD
patients who have not adequately responded to approved OCD mediations, the
completion of remaining protocol-specified analyses in early 2013 and any
future decisions based on those analyses. Transcept may not actually achieve
the plans, carry out the intentions or meet the expectations or projections
disclosed in our forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and projections
disclosed in the forward-looking statements. Various important factors could
cause actual results or events to differ materially from the forward-looking
statements that Transcept makes, including the risks described in detail in
the "Risk Factors" section of Transcept periodic reports filed with the SEC.
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
required by law.

Contact:
Greg Mann
Transcept Pharmaceuticals, Inc.
Sr. Director, Corporate Communications
(510) 215-3567
gmann@transcept.com

SOURCE Transcept Pharmaceuticals, Inc.

Website: http://www.transcept.com
 
Press spacebar to pause and continue. Press esc to stop.