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

Auxilium Prediction: FDA Rejects Crooked Penis Drug

Whether or not FDA is copacetic with the mITT analysis is something that will be revealed next month. Auxilium did not pursue a Special Protocol Assessment (SPA) with FDA to cover the design of the Xiaflex studies.

Xiaflex treatment causes a lot of side effects. Let's take a look at the most common adverse events reported in the two studies:

This is a list that will make any man wince: Penile hematomas, pain, swelling and hemmorrhage were all reported at vastly higher rates in the Xiaflex arm of the study compared to sham injections.

Weighed against the modest efficacy, the risk profile of Xiaflex is troublesome. Even if approved, it's hard to envision scenarios under which the drug is widely used in men with Peyronie's.

One more safety slide looking at serious adverse events (as if the list above wasn't serious?):

Note the three cases of "penile fracture" or "rupture" reported in Xiaflex-treated patients. No such fractures occurred in men treated with sham injections.

All three cases of penile fracture occurred during intercourse. One patient had sex within the 14-day period following a Xiaflex treatment when he was supposed to abstain. A second man's penile fracture was blamed on a "mis-thrust" during sex; while the third occurred during "vigorous intercourse."

All three penile ruptures were surgically repaired successfully.

The FDA approves drugs when the benefit outweighs risks. For Xiaflex, the benefit-risk equation is a tough call. Efficacy is modest at best and comes with significant side effects. Some men with Peyronie's are helped by Xiaflex, but does the drug do enough to be approved?

After looking at the data and the way the studies were conducted and analyzed, I say no. Close, but no.

-- 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.
4 of 4

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
AUXL $36.47 -0.16%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%


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