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

GW Pharmaceuticals Plc Opens An Investigational New Drug Application (IND) In The United States For A Sativex® Phase 3 Clinical Program As A Treatment For Spasticity Due To Multiple Sclerosis

LONDON, Aug. 14, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW") announced today that it has opened a Phase 3 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to conduct a pivotal efficacy and safety clinical program to evaluate Sativex® for the treatment of spasticity due to Multiple Sclerosis (MS). Sativex is currently approved in 22 countries outside the U.S. as a treatment for MS spasticity.

The proposed U.S. Phase 3 program will be conducted under the agreement with GW's licensing partner for Sativex®, Otsuka Pharmaceutical Co. Ltd. Under the terms of GW's agreement with Otsuka, Otsuka is responsible for wholly funding the MS Phase 3 clinical program, as is the case with the current Phase 3 cancer pain program. 

As part of its MS spasticity IND application, GW requested feedback from the FDA on key features of the proposed single Phase 3 trial protocol. GW expects to work with the FDA over the coming months to incorporate FDA feedback and to finalize the protocol design, which may include a request for Special Protocol Assessment (SPA). GW expects the Phase 3 trial to commence in 2014.

Cancer pain remains the initial target indication for Sativex in the U.S. and it is intended that MS spasticity would represent a future second indication for the U.S. market. GW and Otsuka are currently undertaking a Phase 3 clinical trial program for Sativex in cancer pain and results from two pivotal Phase 3 trials are expected in 2014.

"With results from our U.S. Phase 3 program in cancer pain due next year, this new Phase 3 IND provides us with the opportunity to broaden the future U.S. market potential for Sativex to include MS spasticity. As such, this new IND represents an important extension of GW's and Otsuka's ambitions for Sativex in the U.S.," stated Justin Gover, Chief Executive Officer of GW. "We now look forward to working with the FDA to gain agreement on the required program to enable a future filing of an NDA for the MS indication."

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
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 17,826.30 -279.47 -1.54%
S&P 500 2,081.18 -23.81 -1.13%
NASDAQ 4,931.8150 -75.9760 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs