This Day On The Street
Continue to site
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

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

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

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.08 -1.30%
FB $99.94 -1.00%
GOOG $674.80 -1.40%
TSLA $152.84 6.40%
YHOO $26.38 -2.70%


Chart of I:DJI
DOW 15,547.80 -366.94 -2.31%
S&P 500 1,816.86 -35.00 -1.89%
NASDAQ 4,232.2020 -51.39 -1.20%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs