Contact:
Progenics
Pharmaceuticals,
Inc.
aschimmel@scientapr.com
PROGENICS SUBMITS RELISTOR®
SUPPLEMENTAL NDA FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION
IN PATIENTS WITH CHRONIC, NON-CANCER PAIN
Tarrytown,
NY – June 28,
2011 – Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX)
today announced the submission of a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA)
requesting approval for the use of RELISTOR® (methylnaltrexone
bromide) subcutaneous injection for the treatment of opioid-induced
constipation (OIC) in patients with chronic, non-cancer
pain.
RELISTOR is the
first approved medication that specifically targets the underlying
cause of OIC. It is currently approved and sold in the United
States, European Union, Canada, Australia and other countries for
the treatment of OIC in patients with advanced illness who are
receiving palliative care, when response to laxative therapy has
not been sufficient.
“This
regulatory submission is an important milestone for Progenics as we
work with our development and commercialization partner, Salix
Pharmaceuticals, to make RELISTOR available to a broader population
of patients,” said Mark R. Baker, chief executive officer of
Progenics.
Important
Safety Information for RELISTOR
RELISTOR is
indicated 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 sufficient. Use of
RELISTOR beyond four months has not been studied in the advanced
illness population.
RELISTOR is
contraindicated in patients with known or suspected mechanical
gastrointestinal obstruction. If severe or persistent diarrhea
occurs during treatment, advise patients to discontinue therapy
with RELISTOR and consult their physician. Use of
RELISTOR has not been studied in patients with peritoneal
catheters.
Safety and
efficacy of RELISTOR have not been established in pediatric
patients.
