Salix Pharmaceuticals, Inc.
) recieved disappointing news when the U.S. Food and Drug
Administration (FDA) postponed the previously scheduled meeting
on Mar 10-11 to consider the Supplemental New Drug Application
(sNDA) for Relistor.
Relistor is a subcutaneous injection that is currently
approved for the treatment of opioid-induced constipation (OIC)
in patients with advanced illness who are receiving palliative
care, when response to laxative therapy has not been
Salix is looking to get Relistor approved for use in chronic
non-cancer pain in patients with OIC. We note that Salix acquired
the worldwide rights to Relistor (excluding Japan) from
Progenics Pharmaceuticals, Inc
) in Feb 2011.
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's sNDA for Relistor for
OIC in patients with chronic pain.
The Anesthetic and Analgesic Drug Products Advisory Committee
of the FDA was supposed to meet on Mar 10-11 to address the
questions surrounding the class of mu opioid antagonists being
developed for OIC. The meeting was scheduled on the request of
Salix. However, the FDA cited substantial scheduling conflicts
and postponed the meeting.
We were disappointed by the delay in meeting with the FDA
which clearly causes uncertainty in the mind of investors.
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.
Salix currently carries a Zacks Rank #1 (Strong Buy).
Forest Laboratories Inc
) also looks attractive with a comparable Zacks Rank #1.
FOREST LABS A (FRX): Free Stock Analysis
PROGENICS PHARM (PGNX): Free Stock Analysis
SUCAMPO PHARMAC (SCMP): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
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