Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals
(NASDAQ:PGNX) today announced that the FDA will convene an Advisory
Committee on March 10-11, 2014 at which time Salix's Supplemental New
Drug Application (sNDA) for RELISTOR®
(methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced
constipation, or OIC, in patients with chronic pain will be considered.
The date and agenda for the Advisory Committee will not be definitive
until publication in the Federal Register.
The FDA's action to convene an Advisory Committee was taken in response
to the formal appeal by Salix of the complete response action taken by
the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain.
The FDA has stated that it will take action under the appeal within 30
days after receiving input from the Advisory Committee.
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics are frequently prescribed for patients with chronic
pain. Constipation, a common side effect, occurs in patients receiving
opioid therapy. RELISTOR is the first approved medication that
specifically targets the underlying cause of opioid-induced constipation
in patients with advanced illness receiving palliative care when
response to laxative therapy has not been sufficient. Opioids relieve
pain by specifically interacting with mu-opioid receptors within the
brain and spinal cord. However, opioids also interact with mu-opioid
receptors found outside the central nervous system, such as those within
the gastrointestinal tract, resulting in constipation that can be
debilitating. RELISTOR is a peripherally acting mu-opioid receptor
antagonist that does not cross the blood-brain barrier and was
specifically designed to block mu-opioid receptors in the GI tract,
therefore decreasing the constipating effects of opioid pain medications
without affecting their ability to relieve pain.
RELISTOR Subcutaneous Injection was approved in the United States in
2008 for the treatment of opioid-induced constipation in patients with
advanced illness who are receiving palliative care, when response to
laxative therapy has not been sufficient. The use of RELISTOR beyond
four months has not been studied. The drug is also approved for use in
58 countries worldwide, including the European Union, Canada, and
Australia. In the 27 member states of the E.U., as well as Iceland,
Norway and Liechtenstein, RELISTOR is approved for the treatment of
opioid-induced constipation in advanced illness patients who are
receiving palliative care when response to usual laxative therapy has
not been sufficient. In Canada, the drug is approved for the treatment
of opioid-induced constipation in patients with advanced illness,
receiving palliative care. When response to laxatives has been
insufficient, RELISTOR should be used as an adjunct therapy to induce a
prompt bowel movement. Applications in additional countries are pending.
RELISTOR is under license to Salix Pharmaceuticals and Ono
Pharmaceutical from Progenics Pharmaceuticals.
For more information about RELISTOR, please visit www.RELISTOR.com
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection
is contraindicated in patients with known or suspected mechanical
Cases of gastrointestinal (GI) perforation have been reported in adult
patients with opioid-induced constipation and advanced illness with
conditions that may be associated with localized or diffuse reduction of
structural integrity in the wall of the GI tract (i.e., cancer, peptic
ulcer, Ogilvie's syndrome). Perforations have involved varying regions
of the GI tract (e.g., stomach, duodenum, or colon). Use RELISTOR with
caution in patients with known or suspected lesions of the GI tract.
Advise patients to discontinue therapy with RELISTOR and promptly notify
their physician if they develop severe, persistent, or worsening
If severe or persistent diarrhea occurs during treatment, advise
patients to discontinue therapy with RELISTOR and consult their
Use of RELISTOR beyond four months has not been studied.
Safety and efficacy of RELISTOR have not been established in pediatric
The most common adverse reactions reported with RELISTOR compared with
placebo in clinical trials were abdominal pain (28.5%), flatulence
(13.3%), nausea (11.5%), dizziness (7.3%), diarrhea (5.5%), and
Please see complete Prescribing Information for RELISTOR.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription products and medical devices for the
prevention and treatment of gastrointestinal diseases. Salix's strategy
is to in-license late-stage or marketed proprietary therapeutic
products, complete any required development and regulatory submission of
these products, and market them through the Company's gastroenterology
specialty sales and marketing team.
Salix trades on the NASDAQ Global Select Market under the ticker symbol
For more information, please visit our Website at www.salix.com
or contact the Company at 919-862-1000. Follow us on Twitter
(@SalixPharma) and Facebook (www.facebook.com/SalixPharma).
Information on our Twitter feed, Facebook page and web site is not
incorporated in our SEC filings.
Progenics Pharmaceuticals, Inc. of Tarrytown, N.Y. is a
biopharmaceutical company dedicated to developing innovative medicines
to treat disease, with a focus on cancer and related conditions.
Progenics' pipeline candidates include PSMA ADC, a human monoclonal
antibody-drug conjugate in phase 1 testing for treatment of prostate
cancer, and preclinical stage novel multiplex phosphoinositide 3-kinase
(PI3K) inhibitors for the treatment of cancer. Progenics has exclusively
licensed development and commercialization rights for its first
commercial product, Relistor®, to Salix Pharmaceuticals, Ltd.
for markets worldwide other than Japan, where Ono Pharmaceutical Co.,
Ltd. holds an exclusive license for the subcutaneous formulation.
Relistor (methylnaltrexone bromide) subcutaneous injection is a
first-in-class treatment for opioid-induced constipation approved in
more than 50 countries for patients with advanced illness.
Please Note: The materials provided herein that are not
historical facts are or might constitute forward-looking statements
under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Although we believe the expectations reflected in
such forward-looking statements are based on reasonable assumptions, our
expectations might not be attained. Forward-looking statements involve
known and unknown risks that could cause actual results to differ
materially from expected results. Factors that could cause actual
results to differ materially from our expectations expressed in the
report include, among others: the unpredictability of the duration and
results of regulatory review of New Drug Applications and
Investigational New Drug Applications, including specifically results of
appeals and Advisory Committees; the high cost and uncertainty of the
research, clinical trials and other development activities involving
pharmaceutical products; the possible impairment of, or inability to
obtain intellectual property rights and the costs of obtaining such
rights from third parties in an increasingly global market; our
dependence on our first seven pharmaceutical products, particularly
Xifaxan and Relistor, and the uncertainty of market acceptance of our
products intense competition, including from generics in an increasingly
global market; general economic conditions; our need to maintain
profitability; the uncertainty of obtaining, and our dependence on,
third parties to manufacture and sell our products; results of ongoing
and any future litigation and investigations and other risk factors
detailed from time to time in our other SEC filings.
Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Vice President and Chief Financial Officer
Associate Vice President, Investor Relations
and Corporate Communications
Amy D. Martini,