LAVAL, Quebec and TARRYTOWN, N.Y., June
23, 2015 /PRNewswire/ -- Valeant Pharmaceuticals
International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that Valeant
submitted a New Drug Application to the U.S. Food and Drug
Administration (FDA) for RELISTOR® (methylnaltrexone
bromide) Tablets for the treatment of opioid-induced constipation
(OIC) in adult patients with chronic non-cancer pain.
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, and was
approved in 2014 for the treatment of OIC in patients with chronic
non-cancer pain.
About RELISTOR
Progenics has exclusively licensed development and
commercialization rights for its first commercial product,
RELISTOR, to Valeant Pharmaceuticals. RELISTOR (methylnaltrexone
bromide) Subcutaneous Injection is a treatment for opioid-induced
constipation approved in the United States for patients
with advanced illness and chronic non-cancer pain.
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide)
Subcutaneous Injection is contraindicated in patients with known or
suspected gastrointestinal obstruction and patients at increased
risk of recurrent obstruction, due to the potential for
gastrointestinal perforation.
Cases of gastrointestinal 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
gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's
syndrome, diverticular disease, infiltrative gastrointestinal tract
malignancies or peritoneal metastases). Take into account the
overall risk-benefit profile when using RELISTOR in patients with
these conditions or other conditions which might result in impaired
integrity of the gastrointestinal tract wall (e.g., Crohn's
disease). Monitor for the development of severe, persistent, or
worsening abdominal pain; discontinue RELISTOR in patients who
develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise
patients to discontinue therapy with RELISTOR and consult their
physician.
Symptoms consistent with opioid withdrawal, including
hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and
yawning have occurred in patients treated with RELISTOR.
Patients having disruptions to the blood-brain barrier may be at
increased risk for opioid withdrawal and/or reduced analgesia. Take
into account the overall risk-benefit profile when using RELISTOR
in such patients. Monitor for adequacy of analgesia and symptoms of
opioid withdrawal in such patients.
Avoid concomitant use of RELISTOR with other opioid antagonists
because of the potential for additive effects of opioid receptor
antagonism and increased risk of opioid withdrawal.
RELISTOR may precipitate opioid withdrawal in a fetus and should
be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus. In nursing mothers, a decision
should be made to discontinue nursing or discontinue the drug,
taking into account the importance of the drug to the mother.
In the clinical study in adult patients with opioid-induced
constipation and chronic non-cancer pain, the most common adverse
reactions (≥ 1%) were abdominal pain, nausea, diarrhea, and
hyperhidrosis, hot flush, tremor, and chills.
In clinical studies in adult patients with opioid-induced
constipation and advanced illness, the most common adverse
reactions (≥ 5%) were abdominal pain, flatulence, nausea,
dizziness, and diarrhea.
Please see complete Prescribing Information for
RELISTOR.
For more information about RELISTOR, please visit
www.relistor.com.
About the Companies
Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX)
is a multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of dermatology, eye health, neurology and
branded generics. More information about Valeant can be found
at www.valeant.com.
Progenics Pharmaceuticals, Inc. is developing innovative
medicines for oncology, with a pipeline that includes several
product candidates in later-stage clinical development. Progenics'
first-in-class PSMA-targeted technology platform for prostate
cancer includes an antibody drug conjugate therapeutic which
completed a two-cohort phase 2 clinical trial and a small molecule
imaging agent that has also completed a phase 2 trial. Among other
assets in its pipeline of targeted radiotherapy and molecular
imaging compounds is AZEDRA™, an ultra-orphan
radiotherapy candidate currently 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
Valeant Pharmaceuticals International. For additional information,
please visit www.progenics.com.
Editor's Note:
Additional information on Valeant is available at
http://www.valeant.com
Additional information on Progenics is available at
http://www.progenics.com
Valeant
Contact:
|
Laurie W.
Little
Investor Relations
(949)
461-6002
laurie.little@valeant.com
|
|
|
|
|
Progenics
Contact:
|
Melissa
Downs
Investor
Relations
(914)
789-2801
mdowns@progenics.com
|
|
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SOURCE Valeant Pharmaceuticals International, Inc.