This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Transcept Pharmaceuticals Announces That A Phase 2 Clinical Trial Of TO-2061 As Adjunctive Therapy For Obsessive Compulsive Disorder Did Not Meet Primary Endpoint

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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs