Progenics Pharmaceuticals, Inc. (PGNX - Snapshot Report) 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.
Currently, Sucampo Pharmaceuticals, Inc.’s 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 adult women.
Progenics carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF - Snapshot Report) with a Zacks Rank #1 (Strong Buy).