Salix Pharmaceuticals, Ltd.
) recently announced that the FDA's advisory panel will review
Salix' supplemental new drug application (sNDA) for Relistor for
opioid-induced constipation (OIC) in patients with chronic
Salix had received a complete response letter (CRL) from the
FDA in Jul 2012 for the Relistor sNDA. In the CRL, the FDA had
asked for additional data.
The FDA's concerns regarding the class of drugs (peripheral
mu-opioid antagonist) to which Relistor belongs were based on a
potential cardiovascular (CV) safety signal observed in a
12-month safety study conducted with another peripheral mu-opioid
antagonist for the treatment of OIC in patients with chronic
non-cancer pain. While the Relistor sNDA did not show any CV
signal, the FDA expressed concern regarding the lack of a control
population for the long-term safety data.
The FDA also emphasized the need to provide consistent advice
regarding major adverse cardiovascular event (MACE) studies that
should be conducted by companies developing drugs belonging to
this class for the specified indication.
Salix had conducted an end of review meeting in Oct 2012 in
order to gain a better understanding of the CRL. Salix had also
filed a formal appeal regarding the CRL. According to Salix,
currently available post-marketing, clinical and preclinical data
could be enough to gain approval. The FDA will arrive at a
decision on the appeal once the meeting takes place. A date is
yet to be finalized for the advisory panel meeting.
The panel will mainly discuss the potential for drugs in this
class to cause withdrawal symptoms, the safety data available on
Relistor where a potential CV signal is concerned and the need
and timing (pre-approval versus post-approval) for conducting
MACE studies with drugs of this class.
The FDA's decision regarding the advisory panel meeting comes
as a positive surprise for Salix and shares were up 5% on the
news. While we believe an additional study will most likely be
required for approval, we do not expect a significant delay in
the approval process for Relistor.
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 sales came in
at about $7.6 million in the first quarter of 2013.
Salix currently carries a Zacks Rank #1 (Strong Buy). Other
stocks that look equally attractive include
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
PROGENICS PHARM (PGNX): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
To read this article on Zacks.com click here.