Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) and Progenics Pharmaceuticals,
Inc. (Nasdaq:PGNX) announced today that the submission to the European
Medicines Agency (EMA) of RELISTOR®(methylnaltrexone bromide)
Subcutaneous Injection for the treatment of opioid-induced constipation
(OIC) in adult patients with chronic non-cancer pain, has been accepted
for review. If approved, this will add to the current marketing
authorization in the European Union (EU), which allows for the use of
RELISTOR® in advanced illness patients.
The marketing of RELISTOR for the treatment of OIC in advanced illness
patients was approved in the European Union in 2008, and is currently
approved in more than 50 countries. RELISTOR remains the only single
agent product approved for the treatment of OIC in the EU. If approved,
it is anticipated that RELISTOR will be immediately available to this
newly expanded population of patients in the EU using opioids to control
chronic pain.
About RELISTOR
RELISTOR is a peripherally acting mu-opioid receptor antagonist
specifically designed to block the constipating effects of opioid pain
medications in the gastrointestinal tract. RELISTOR does not cross the
blood-brain barrier, therefore relieving the distressing effects of the
constipation without affecting the analgesic effect of the opioid.
RELISTOR Subcutaneous Injection has been FDA approved since 2008 to
treat OIC in patients with advanced illness who are receiving palliative
care, when response to laxative therapy has not been sufficient.
About Opioids, Constipation and RELISTOR®
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 OIC in these patients.
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 OIC 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 over 50 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 OIC 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 OIC 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 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
gastrointestinal obstruction.
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
abdominal symptoms.
If severe or persistent diarrhea occurs during treatment, advise
patients to discontinue therapy with RELISTOR and consult their
physician.
Use of RELISTOR beyond four months has not been studied.
Safety and efficacy of RELISTOR have not been established in pediatric
patients.
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
hyperhidrosis (6.7%).
RELISTOR full Prescribing Information for the U.S. is available at www.RELISTOR.com.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical 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 commercialize them through the
Company’s 500-member specialty sales force.
Salix trades on the NASDAQ Global Select Market under the ticker symbol
“SLXP”.
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.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for
oncology, with a pipeline that includes several product candidates in
late-stage clinical development. Progenics’ first-in-class PSMA targeted
technology platform includes an antibody drug conjugate therapeutic in a
phase 2 clinical trial and a small molecule targeted imaging agent in
which a phase 2 trial has just completed. Among other assets in its
pipeline of targeted radiotherapy and molecular imaging compounds is
Azedra™, an ultra-orphan radiotherapy candidate also in a
phase 2 study under an SPA. Progenics’ first commercial product, Relistor®
(methylnaltrexone bromide) for opioid-induced constipation, is partnered
with and marketed by Salix Pharmaceuticals, Inc. For additional
information, please visit www.progenics.com.
Additional information concerning Progenics and its business may be
available in press releases or other public announcements and public
filings made after this release.
Information on or accessed through our website is not included in the
company's SEC filings.
This press release may contain projections and other forward-looking
statements regarding future events. Such statements are predictions
only, and are subject to risks and uncertainties that could cause actual
events or results to differ materially. These risks and uncertainties
include, among others, the cost, timing and results of clinical trials
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Investigational NDAs; market acceptance for approved products; generic
and other competition; the possible impairment of, inability to obtain
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Progenics and such risks and uncertainties is available on its website,
and in its press releases and reports it files with the U.S. Securities
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press release as of its date and does not undertake any obligation to
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Copyright Business Wire 2014