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

Auxilium Prediction: FDA Rejects Crooked Penis Drug

Stocks in this article: AUXL

The margin of victory in the IMPRESS-2 study on the PDQ bother score was even smaller, with a p value of 0.0496. If a patient sneezed at the wrong time, this portion of the study would have failed.

Obviously, the marginal Peyronie's "bothersomness" improvement attributable to Xiaflex is a worrisome issue with respect to FDA approval. Auxilium needs to demonstrate a clinical benefit for Peyronie's patients beyond just some reduction in crooked penis angles. The company chose "bother" as a co-primary endpoint but results are far from a home run. I'm sure someone at the FDA is also asking Auxilium to explain why the other two components of the PDQ score were excluded from the primary efficacy analysis of the phase III studies.

The two other components of the PDQ scale were included in the studies as secondary endpoints. Xiaflex failed to improve psychological and physical symptoms of Peyronie's compared to sham injections when the two studies were assessed individually. When Auxilium combined data from the two studies, this measure reached statistically significance.

Xiaflex did not reduce penile pain compared to sham injection when the two studies were analyzed individually or combined.

Before I finish up on the Xiaflex efficacy data, take another look at the two slides above. In the bottom left-hand corner of each, Auxilium notes the analyses were conducted on an "MITT" or modified intent-to-treat patient population.

Uh oh.

Take a look at this slide, which charts the patient disposition from the IMPRESS studies.

I'll do the math for you. Across both studies, 832 patients were enrolled and comprise the intent-to-treat (ITT) patient population. However, 220 of these patients, or 26 percent, were excluded from the primary endpoint analysis. Auxilium says a majority of these patients were excluded intentionally (and within the statistical rules of the studies) because they were sexually inactive within three months of baseline PDQ measurements. Since sexuality activity was a pre-requisite for PDQ scores, they couldn't be included in the primary analysis.

Auxilium announced top-line results from the IMPRESS 1 and 2 studies in June 2012. At that time, the company's rationalization for excluding 26 percent of the enrolled patients from the primary efficacy analysis did not go over well with investors. One benefit of Xiaflex touted by Auxilium is the ability of men to resume sexual activity. If that's true, then why would the company exclude from its efficacy analysis men who were unable to have sex at study baseline but may have started to have sex after a year of Xiaflex therapy?

3 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!

Markets

DOW 17,678.70 +6.10 0.03%
S&P 500 2,057.09 +5.27 0.26%
NASDAQ 4,771.7630 +13.8840 0.29%

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