Progenics Pharmaceuticals, Inc.
) is working hard to further develop its opioid-induced
constipation (OIC) portfolio. Currently, the company's OIC
portfolio includes, Relistor, which also the only one marketed
product of Progenics.
Relistor is a subcutaneous injection that is currently
approved for the treatment of OIC in patients with advanced
illness who are receiving palliative care, when response to
laxative therapy has not been sufficient. Relistor global sales
came in at $7.9 million in the second quarter of 2013.
Progenics has a license agreement with
Salix Pharmaceuticals Ltd.
) for the development and commercialization of Relistor worldwide
except in Japan, where Progenics has licensed the rights to the
subcutaneous formulation to Ono Pharmaceuticals Co. Ltd.
Progenics and Salix have announced that the Supplemental New
Drug Application (sNDA) for Relistor for the treatment of OIC in
patients with chronic pain will be considered by the U.S. Food
and Drug Administration (FDA) at an Advisory Committee meeting
scheduled for Mar 10-11, 2014.
A response from the FDA is expected within 30 days after
evaluation by the Advisory Committee.
We remind investors that Salix had received a complete
response letter (CRL) from the FDA in Jul 2012 for its sNDA on
Relistor. In the CRL, the FDA had asked for additional data.
Subsequently, in Jun 2013, Progenics and Salix announced that the
FDA's advisory panel will review Salix' sNDA for Relistor for OIC
in patients with chronic pain.
Sucampo Pharmaceuticals, Inc.
) Amitiza is the approved treatment for OIC in patients with
chronic pain. In Jul 2013, Amitiza was launched in the U.S. for
the treatment of OIC in adults with chronic, non-cancer pain.
Amitiza is also approved for other indications. Amitiza is
approved by the FDA for chronic idiopathic constipation (CIC) in
adults and irritable bowel syndrome with constipation (IBS-C) in
Progenics carries a Zacks Rank #3 (Hold). Companies that
currently look well-positioned include
) with a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
PROGENICS PHARM (PGNX): Free Stock Analysis
SUCAMPO PHARMAC (SCMP): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
To read this article on Zacks.com click here.