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

Titan Pharma: FDA Panel Live Blog

BETHESDA, Md. ( TheStreet) -- An FDA advisory panel will spend Thursday reviewing a long-acting treatment for opioid addiction from Titan Pharmaceuticals (TTNP - Get Report).

The panel is expected to be contentious because FDA's own reviewers expressed doubts about the ability of Titan's drug, known as Probuphine, to adequately curb addiction. The FDA's concerns, made public in a review of Probuphine released Tuesday, caused Titan shares to fall 41% to $1.19. The stock rebounded slightly Wednesday, closing at TK.

Probuphine is a small plastic rod embedded with buprenorphine that is implanted under the skin of the upper arm. Unlike oral forms of buprenorphine that must be taken daily, Probuphine is designed to release buprenorphine continuously for six months.

Titan conducted clinical studies demonstrating that opioid addicts implanted with Probuphine were less likely to relapse than patients treated with placebo. The FDA, in its review, said Probuphine's dose may be too low to produce clinically meaningful results. A majority of Probuphine patients in the study required additional oral buprenorphine and only 8% of patients reported opioid-negative urine tests for at least 80% of tests.

"While the placebo group had even more discouraging results, supporting the conclusion that Probuphine does have an effect on drug use, overall, the response was not what one might hope for given that the product ensures compliance with the medication for six months," the FDA review stated.

FDA also raised concerns about the complications arising from the surgical insertion and removal of the Probuphine implant.

Sales of oral forms of buprenorphine, mostly quick-dissolving tablets and film, totaled more than $1 billion last year.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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
TTNP $5.95 -5.41%
AAPL $93.74 -1.15%
FB $117.58 0.73%
GOOG $693.01 0.29%
TSLA $240.76 -2.81%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs