This Day On The Street
Continue to site
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 Wins Sleeping Pill Approval

RICHMOND, Calif. ( TheStreet) -- U.S. regulators on Wednesday approved a new, quick-dissolving sleeping pill from Transcept Pharmaceuticals (TSPT) aimed at people who wake in the middle of the night but cannot fall back to sleep.

Transcept's Intermezzo is a low-dose formulation of zolpidem, the active ingredient in the popular and now generic sleeping pill Ambien. Unlike most sleeping pills taken at bedtime, Intermezzo is used in the middle of the night and will therefore come with significant restrictions and warnings to minimize the risk that people wake up the next morning still drowsy and drive while impaired.

People taking Intermezzo will be instructed to make sure they have at least four hours of bedtime remaining and to not drive a car for a minimum of five hours after dosing.

Transcept convinced the U.S. Food and Drug Administration to approve Intermezzo after two previous efforts were rejected due to safety concerns with the sleeping pill. Transcept conducted a driving study to demonstrate that people could take Intermezzo in the middle of the night and drive the next day without impairment. The company also lowered the Intermezzo dose for women because of data showing that women take longer to clear the drug from their bloodstream.

With Intermezzo approval, Transcept partner Purdue Pharma has 10 days to decide whether it will sell the drug in the U.S. If Purdue opts in, Transcept will receive a royalty on sales plus various milestone payments.

Following approval, questions remain whether the new label proposal and instructions for use are "restrictive and have reduced the sales potential for the drug," wrote Zacks analyst Jason Napodano in a recent research note. Napodano sees peak sales of Intermezzo reaching $254 million and has a price target for Transcept of $8 per share.

Somaxon Pharmaceuticals (SOMX) won approval and launched a new sleeping pill, Silenor, last year but sales have disappointed due largely to cheap, generic competitors.

Transcept shares closed Tuesday at $6.61 but have traded as high as $8.72 in recent weeks.

-- Written by Adam Feuerstein in Boston
1 of 2

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
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
TSPT $30.00 0.67%
AAPL $93.24 0.00%
FB $117.81 0.00%
GOOG $701.43 0.00%
TSLA $211.53 0.00%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs