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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Tonix Pharmaceuticals Completes Pre-IND Meeting With FDA On TNX-201 For Episodic Tension-Type Headache: Clinical Development To Begin In 4Q 2014

Stocks in this article: TNXP

NEW YORK, March 3, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a development stage specialty pharmaceutical company, today announced that it recently held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory pathway for the development of TNX-201 (single isomer isometheptene, or IMH) for the relief of episodic tension-type headache (ETTH). ETTH is the medically-recognized term for tension headache, a common problem affecting approximately 20% of the global adult population.

"Following this informative meeting with the FDA, we can confirm the initial IND for TNX-201 will not require any additional nonclinical data to support a first-in-man study. This enables us to enter the clinic promptly with minimum risk, which is consistent with our platform of repurposing, reformulating, or rediscovering high impact prescription medications for unmet or under-served needs and particularly for pain syndromes. We are on track to evaluate TNX-201 in a clinical pharmacology study in the fourth quarter of 2014," said Seth Lederman, M.D., president and CEO of Tonix.

"Selecting a single isomer of IMH for development can potentially reduce the toxicity associated with the racemic mixture based on our pharmacology data, which is consistent with the FDA Stereoisomeric Drugs Development Policy. Although the development of TNX-201 will be based on the available information on racemic IMH, the New Drug Application (NDA) approval will conform with the current 505(b)(1) NDA requirement." noted Dr. Lederman.

TNX-201 has the potential to become the first new prescription drug for tension headache in more than 20 years. Currently, the only FDA-approved prescription medications for tension headache contain butalbital. Prescription products containing barbiturates can be habit forming and are associated with the development of Medication Overuse Headache, a chronic syndrome that is difficult to treat. "TNX-201, if approved, will provide people who suffer from tension headaches a treatment alternative to barbiturate drugs, as well as to over-the-counter medicines containing acetaminophen and caffeine," said Dr. Lederman.

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!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

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