This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Auxilium Prediction: FDA Rejects Crooked Penis Drug

Stocks in this article: AUXL

Let's go the slides. First, let's take a look at the obvious co-primary endpoint, which assessed Xiaflex's ability to straighten those crooked penises following a year of treatment.

Both studies hit this primary endpoint with strong statistical significance. In the IMPRESS-1 study, men in the Xiaflex arm had 49 degrees of bend in their penis at baseline. After 52 weeks, the bend was reduced to 31 degrees, or a 38 percent improvement. Men in the sham injection arm entered the study with penises that curved, on average, by 49 degrees. At study end, that curve was 39 degrees, or a 21 percent improvement. Results from the IMPRESS-2 study were similar, as displayed in the slide.

Does statistical significance translate into a clinically meaningful benefit? That's a tough question here given the high placebo response rate. On placebo-adjusted basis, Xiaflex only reduced penile curvature by 8 degrees. That's not much of an improvement, particularly when you factor in side effects, which I'll discuss in a bit.

Auxilium argues it's more relevant to look at individual patient results compared to their own baseline and not against the placebo injections. Fine, but even looking at just the Xiaflex arm, is reducing the bend of a penis, on average, from 49 degrees to 31 degrees, a robust-enough result to warrant approval? There are no "straight" penises at the end of this study, unlike Xiaflex's ability to fully straighten fingers in patients with Dupuytren's Contracture. Does that matter?

Next slide. This one graphs the second co-primary endpoint of the studies -- the reduction in a Peyronie's "PDQ bother" score. Auxilium developed the PDQ questionnaire to assess the overall impact on quality of life that Peyronie's has on men with the disease. Using 15 questions, the PDQ measures 1) the "bothersomness" of Peyronie's; 2) psychological and physical symptoms of Peyronie's; and 3) penile pain.

For the phase III studies co-primary endpoint, Auxilium only used responses to four of 15 questions that measure the "bother" portion of the PDQ. Here are the results:

Looking at IMPRESS-1 results, you see a 44 percent reduction in the bother score for men treated with Xiaflex compared to a 27 percent reduction for men treated with sham injections. The placebo-adjusted difference is small but still statistically significant with a p value of 0.0451. A p value greater than 0.05 would have been a negative result so this study barely passed.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!


DOW 17,416.85 +225.48 1.31%
S&P 500 2,021.25 +19.09 0.95%
NASDAQ 4,683.4070 +45.4130 0.98%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs