Published on July 26, 2012 at 9:58 PM
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."
Source: Sucampo Pharmaceuticals, Inc.