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

RedHill Biopharma Submits New Drug Application To U.S. FDA For RHB-103 Anti-Migraine Oral Thin Film

Stocks in this article: RDHL

TEL-AVIV, Israel, March 27, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, today announced that the Company and its co-development partner, IntelGenx Corp. ("IntelGenx"), have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine.

The NDA was submitted under a 505(b)(2) regulatory path, following a positive pre-NDA meeting with the FDA and is supported by a successful bioequivalence clinical trial that demonstrated the required FDA criteria for therapeutic equivalence between the soluble oral film of RHB-103 and Merck & Co.'s Maxalt MLT ®.

RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1 agonist and the active drug in Merck & Co.'s Maxalt ® drugs. Rizatriptan is considered one of the most effective oral triptans - a class of molecules that constrict blood vessels in the brain in order to relieve swelling and other migraine symptoms. The worldwide market of triptans was estimated at approximately $2.1 billion in 2011 1, of which the worldwide direct sales of Merck & Co.'s rizatriptan-based drugs exceeded $600 million 2.

RHB-103 is based on IntelGenx' proprietary "VersaFilm TM" technology. The RHB-103 thin film strip dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream.

"We are very pleased with the submission of the NDA for RHB-103. It is our first NDA and an important milestone for RedHill and IntelGenx, as it brings us one step closer to making this attractive thin film rizatriptan drug available for migraine patients in need," said Elkan Gamzu, RedHill's RHB-103 Product Manager. "RedHill's RHB-103 oral thin film is characterized by rapid dissolution, ease of use, pleasant flavoring, and the ability to administer without water, all of which we believe are important for patients who suffer from migraines."

RedHill further reported on February 25, 2013 of its plan to submit a second NDA in the fourth quarter of 2013, for the U.S. marketing approval of RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron for the prevention of nausea and vomiting in cancer patients. The RHB-102 planned NDA submission follows a successful bioavailability trial, as well as a recent Type B meeting with the FDA.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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 16,461.32 -153.49 -0.92%
S&P 500 1,927.11 -14.17 -0.73%
NASDAQ 4,382.8470 -36.6310 -0.83%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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