This Day On The Street
Continue to site
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

Valeant Pharmaceuticals Announces Publication Of Efinaconazole Phase III Results

MONTREAL, Nov. 26, 2012 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced today that the Journal of the American Academy of Dermatology has published the positive results from our two pivotal, international,  multicenter, randomized, double-blind, vehicle-controlled studies that were conducted in 1,655 subjects with onychomycosis. Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi, resulting in nail destruction and deformity. The only approved topical treatments are lacquers with very limited efficacy. Oral treatments, while more efficacious, are limited by drug interactions and numerous safety concerns including the potential for acute liver injury. Valeant investigated the safety and efficacy of efinaconazole 10% topical solution (efinaconazole), the first triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).

The study's primary endpoint was stringently defined as the complete cure rate at Week 52, which means that the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with efinaconazole were completely cured, as compared to only 3.3% of subjects treated with vehicle and in Study 2, 15.2% of subjects treated with efinaconazole were completely cured, as compared to only 5.5% of subjects treated with vehicle. Using the secondary endpoint of complete or almost complete cure, defined as  < 5% clinical involvement and 100% mycologic cure, the success rates for efinaconazole increased to 26.4% and 23.4%, respectively.  The adverse events that were reported were generally mild and transient and were similar between subjects treated with efinaconazole solution 10% and vehicle.

"We are pleased to share the positive results from the two Phase III studies of efinaconazole with the publication by a leading dermatology journal," stated J. Michael Pearson, chairman and chief executive officer.  "While oral treatment of onychomycosis has been the standard of care, drug interactions and risk of acute liver injury may limit their use especially in older adults where disease is most prevalent, those on multiple drug regimens, or for patients or doctors who prefer topical therapies. As no new onychomycosis treatments have been introduced for over 10 years, we believe in the authors' conclusion that this may be the first topical treatment option for DLSO that can be considered a viable alternative to oral treatments."

"This is a very exciting time for patients with the pending launch of the first new topical anti-fungal treatment approved in more than a decade," said Boni Elewski, MD Professor of Dermatology, University of Alabama.  "Onychomycosis is a common infection that, left untreated, can later appear not only on other toes and fingers, but also on friends and family, too. It is estimated that one in ten Americans suffer from onychomycosis, which causes the nail to thicken and can be quite painful, making this condition more than just a cosmetic problem.  Furthermore, as some research indicates that up to half of patients over the age of 70 suffer from this progressive disease. An effective topical therapy like efinaconazole is a logical treatment option to avoid drug interactions and systemic side effects, as these patients undoubtedly take other oral medications."

For the complete article, please go to http://www.jaad.org.

Trial Design

The two large, international, multicenter, randomized, double-blind, vehicle-controlled studies were conducted in subjects with onychomycosis affecting at least one great toenail. The toenail was required to have at least 20-50% of clinical involvement.  Study 1 had 870 subjects and Study 2 had 785. They were randomized in a 3:1 ratio to efinaconazole topical solution 10% or to vehicle.  Treatment was applied once-daily for 48 weeks, with post-treatment follow-up occurring at Week 52. Debridement was not performed in the studies.

1 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
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
SYM TRADE IT LAST %CHG

Markets

DOW 18,010.68 -115.44 -0.64%
S&P 500 2,107.39 -13.40 -0.63%
NASDAQ 5,070.0260 -27.95 -0.55%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs