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

Stiefel Receives US FDA Approval Of Sorilux™ Foam, 0.005% For Topical Treatment Of Plaque Psoriasis Of The Scalp

RESEARCH TRIANGLE PARK, N.C., Sept. 28, 2012 /PRNewswire/ -- Stiefel, a GSK (NYSE:GSK) company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old.

"Studies have shown that in at least 50 percent of psoriasis cases, the scalp is involved," said Susan Learned, PharmD, MD, PhD, Medicines Development Leader, Dermatology Research and Development, Stiefel. "We believe this additional indication for Sorilux Foam will help meet the needs of both patients and physicians."

The approval of Sorilux Foam for treatment of plaque psoriasis of the scalp was based on a multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3b study of patients with moderate scalp and body psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas. The incidence of these adverse reactions was similar between the body and scalp. It is for use on the skin only. It is not for facial, oral, ophthalmic, or intravaginal use. More information about the clinical trial results can be found in the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Sorilux_Foam.pdf.

About Plaque Psoriasis

Psoriasis is a chronic (life-long) skin disease. It occurs when the immune system "speeds up" the growth cycle of skin cells. A normal skin cell matures and falls off the body in about a month.  For people with plaque psoriasis, it can take only three or four days for new skin cells to develop. Instead of falling off, the cells remain on the skin and form thickened patches (lesions or plaques). While plaque psoriasis is a chronic condition, many patients experience times when their symptoms improve or worsen.

1 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
Only $9.95
14-Days Free
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

Markets

DOW 17,698.18 -77.94 -0.44%
S&P 500 2,059.69 -8.20 -0.40%
NASDAQ 4,880.2280 -20.6570 -0.42%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs