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
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Depomed Bear Case: FDA Panel Will Ding Serada

Statistics aside, it's the absolute efficacy benefit of Serada in VMS that will be the central review issue. I expect the FDA and the experts on its advisory panel to raise questions and concerns about the placebo-adjusted frequency and severity scores. Serada's inability to demonstrate durable effect at 24 weeks -- the regulatory benchmark for approval of VMS drugs -- will also be problematic for Depomed.

Let's now discuss the third phase III trial that Depomed conducted of Serada in VMS, this time under a Special Protocol Assessment agreement with FDA. BREEZE-3 was a double blind, placebo-controlled study of approximately 600 patients, randomized to receive a Serada total dose of 1800 mg or placebo. The co-primary efficacy endpoints were reductions in the mean frequency of moderate-to-severe hot flashes and the average severity of hot flashes, measured after four and 12 weeks of stable treatment. As in the prior BREEZE-1 trial, the treatment duration of the study was six months to establish the regulatory requirement for persistence of efficacy.

Mixed results from BREEZE-3 were reported in October 2012: Using the pre-specified, statistical analysis plan, Serada demonstrated a statistically significant reduction in the average frequency of hot flashes and severity of hot flashes at four weeks. At 12 weeks, Serada failed to demonstrate a statistically significant reduction in the average frequency of hot flashes but did show a statistically significant reduction in hot flash severity.

At 24 weeks, Serada failed to demonstrate a statistically significant benefit on either of the two measures of VMS efficacy.

While Depomed bulls argue otherwise, it is clear to me that the efficacy of Serada as defined by the SPA agreement was not fully met in the BREEZE-3 study. Like in the previous negative studies, Serada failed to demonstrate a significant reduction in the frequency of hot flashes beyond four weeks. Across all three phase III studies, the data compiled cast major doubts against Serada's proving a meaningful benefit in VMS, especially when women experience symptoms for months to years.

Bulls also contend that Serada should be approved because women suffering from VMS deserve a safer alternative than the current standard treatment, hormone replacement therapy. While hormone replacement therapy can be used safely for prolonged periods of time in a lot of cases, I agree that there will be some women for whom an alternative therapy is preferred. Luckily, the FDA panel on March 4 will be reviewing just such a safe, effective treatment for VMS on the same day that it shoots down Serada.

I'm referring to Noven Pharmaceuticals' Low-Dose Mesylate Salt of Paroxetine (LDMP), which is also currently under FDA review for the treatment of VMS associated with menopause. Paroxetine is a highly selective serotonin-reuptake inhibitor and the potential mechanism of its action in VMS would relate to normalizing serotonin signaling in the brains' temperature control area.

2 of 3

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
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!
SYM TRADE IT LAST %CHG
DEPO $22.41 -1.84%
AAPL $124.43 -1.54%
FB $82.22 -1.18%
GOOG $548.00 -0.73%
TSLA $188.77 -0.94%

Markets

DOW 17,776.12 -200.19 -1.11%
S&P 500 2,067.89 -18.35 -0.88%
NASDAQ 4,900.8850 -46.5560 -0.94%

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