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

Sucampo And Takeda Announce Filing Of Supplemental New Drug Application For AMITIZA (Lubiprostone) In Opioid-induced Constipation

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A. Inc. (TPUSA) today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA® (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

The filing is based on results from three Phase 3, well-controlled studies of 12 weeks’ duration in patients taking opioids chronically for non-cancer pain, as well as a long-term, open-label safety study, which provide additional support for use in this population.

“We believe that the data provided in the sNDA application demonstrate that lubiprostone could provide a potential oral treatment option for patients with OIC,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and CEO of SPI. “We are seeking priority review of this application, as we believe physicians and their patients are in need of new therapies to address OIC that may not affect opioid analgesia. If approved, this would be the third indication for the lubiprostone franchise and allow more patients access to this medicine.”

Opioid-induced constipation is one of the most common side effects of opioid-based medicines, which are used in the management of chronic pain. OIC affects the majority of patients treated chronically with opioids. Some patients discontinue opioid therapy and thereby endure pain rather than suffer from the constipation the opioids cause.

“This submission is an important milestone for both companies,” said Charlie Baum, Vice President, U.S. Medical Affairs, Takeda. “It is critical that we continue to identify and respond to unmet needs of patients with constipation, including OIC.”

About Lubiprostone

AMITIZA (lubiprostone) is a chloride channel activator indicated for the treatment of chronic idiopathic constipation (24 mcg twice daily) in adults and for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older by the FDA in the United States. AMITIZA (lubiprostone) is approved in Japan for the treatment of chronic constipation (excluding constipation caused by organic diseases) and in Switzerland for chronic idiopathic constipation.

1 of 5

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!
SYM TRADE IT LAST %CHG

Markets

DOW 18,110.14 +72.17 0.40%
S&P 500 2,112.11 +3.19 0.15%
NASDAQ 5,047.2750 -12.9710 -0.26%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs