Marketing Approval Expands Treatment to Include
Nearly 11 Million Patients Who Experience Opioid-Induced
Constipation While Taking Opioids for Chronic Non-Cancer Pain
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics
Pharmaceuticals, Inc. (NASDAQ:PGNX) today announced that the Food
and Drug Administration has approved RELISTOR® (methylnaltrexone
bromide) Subcutaneous Injection, 12 mg/0.6ml, for the treatment of
opioid-induced constipation (OIC) in patients taking opioids for
chronic non-cancer pain. RELISTOR subcutaneous injection is
currently the only available peripherally acting mu opioid receptor
antagonist (PAMORA) that is approved for treating OIC at the cause
without interfering with the centrally acting analgesic properties
of the opioid.
“Frequently, opioid analgesics are prescribed to manage pain in
patients suffering from chronic conditions. Unfortunately, the use
of an opioid can result in debilitating constipation for a
significant number of these patients,” stated Bill Forbes,
Executive Vice President, Medical, Research and Development and
Chief Development Officer, Salix. “The approval and availability of
RELISTOR for treating the underlying cause of OIC provides an
important and welcomed advancement for many patients who experience
constipation while taking opioids for chronic non-cancer pain.”
Traditional laxative treatments are often ineffective for many
chronic pain patients suffering with opioid-induced constipation.
Approximately 80% of chronic pain patients with OIC that were
taking laxative therapy continued to report difficulties dealing
with their constipation symptoms, as documented by a large patient
survey published in 2008 in Pain Medicine. One third of these
chronic pain patients reported stopping or lowering their opioid
dose in order to relieve their opioid induced constipation,
resulting in increased pain levels.
“Unlike other opioid-related side effects, such as nausea and
vomiting, constipation never goes away,” said Eugene Viscusi, MD,
Director of Acute Pain Management, Department of Anesthesiology at
Thomas Jefferson University in Philadelphia. “Constipation is one
of the side effects for which patients do not develop tolerance
with chronic exposure. It can be a significant burden affecting a
patient’s ability to function adequately.”
Dr. Viscusi continued, “Patients generally experience a rapid
bowel movement following administration of methylnaltrexone, often
within 30 minutes. Unlike laxatives, RELISTOR offers patients a
relatively predictable timed response for a bowel movement.
Additionally, most patients describe the sensation like a normal
bowel activity. These attributes of treatment with RELISTOR are
tremendous advantages.”
About the Phase III Clinical Trial for OIC in chronic
non-cancer pain
A randomized, double blind, placebo-controlled trial was
conducted to evaluate the efficacy and safety of RELISTOR 12mg once
daily for the treatment of opioid induced constipation in patients
with chronic non-cancer pain.
A total of 312 patients with a history of non-cancer pain and
taking opioids for at least one month prior to study entry were
eligible for enrollment. Patients also had confirmed OIC defined at
<3 spontaneous bowel movements per week during the screening
period. Constipation due to opioid use had to be associated with 1
or more of the following: A Bristol Stool Form Scale score of 1 or
2 for at least 25% of the bowel movements (BM), straining during at
least 25% of the BMs or a sensation of incomplete evacuation after
at least 25% of the BMs. The median duration of opioid-induced
constipation at baseline was 59 months. The median daily baseline
oral morphine equivalent dose was 161 mg. Patients were
randomized to receive RELISTOR 12 mg or placebo once daily for four
weeks followed by an eight week open label phase when patients
could take medications as needed.
In the study a significantly greater portion of patients taking
RELISTOR 12mg daily reported having three or more spontaneous bowel
movements (SBM) per week during the four week double blind period
compared to placebo (59% vs. 38%). Following the first dose, 33% of
patients in the RELISTOR 12 mg once daily treatment group had a SBM
within 4 hours and approximately half of patients had a SBM prior
to the second dose of RELISTOR.
RELISTOR subcutaneous injection was well tolerated and the
adverse event profile was consistent with other studies of RELISTOR
in an advanced illness population. The most commonly reported side
effects included: abdominal pain (21%), diarrhea (6%), nausea (9%)
and hyperhidrosis (6%)
About Opioids, Constipation and RELISTOR (methylnaltrexone
bromide)
Opioid analgesics are frequently prescribed for patients with
chronic pain, including patients with advanced illness. An
estimated 27 million patients in the US take opioids for chronic
pain. Constipation is one of the most common and distressing side
effects in patients receiving chronic opioid therapy. Approximately
40% of chronic pain patients, or nearly 11 million patients, on
opioid therapy will experience OIC. RELISTOR is the first approved
medication that specifically targets the underlying cause of
OIC.
RELISTOR is a Peripherally Acting Mu Opioid Receptor Antagonist
(PAMORA) specifically designed to block the constipating effects of
opioids in the gastrointestinal tract. The unique molecular
structure of RELISTOR restricts it from crossing the blood-brain
barrier and interfering with the analgesic effect of opioids.
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 in the advanced illness
population. The drug is also approved for use in over 50 countries
worldwide, including the European Union, Canada, and Australia. In
the 28 member countries 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, Inc. from Progenics Pharmaceuticals,
Inc.
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
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 and should be
monitored closely for adequacy of analgesia and symptoms of opioid
withdrawal.
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.
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 markets XIFAXAN® (rifaximin) tablets 200 mg and 550 mg,
MOVIPREP® (PEG 3350, sodium sulfate, sodium chloride, potassium
chloride, sodium ascorbate and ascorbic acid for oral solution, 100
g/7.5 g/2.691 g/1.015 g/5.9 g/4.7 g), OSMOPREP® (sodium phosphate
monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous,
USP) Tablets, APRISO® (mesalamine) extended-release capsules 0.375
g, UCERIS® (budesonide) extended release tablets, for oral use,
UCERIS (budesonide) rectal foam, GIAZO® (balsalazide disodium)
tablets, COLAZAL® (balsalazide disodium) Capsules, GLUMETZA®
(metformin hydrochloride extended-release tablets) 500 mg and 1000
mg, ZEGERID® (omeprazole/sodium bicarbonate) Powder for Oral
Suspension, ZEGERID® (omeprazole/sodium bicarbonate) Capsules,
METOZOLV® ODT (metoclopramide hydrochloride), RELISTOR®
(methylnaltrexone bromide) Subcutaneous Injection, FULYZAQ®
(crofelemer) delayed-release tablets, SOLESTA®, DEFLUX®, RUCONEST®
C1 esterase inhibitor (recombinant), PEPCID® (famotidine) for Oral
Suspension, DIURIL® (chlorothiazide) Oral Suspension, AZASAN®
(azathioprine) Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5%
(Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository
(Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream,
USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal
Suppositories) 30 mg, CYCLOSET® (bromocriptine mesylate)
tablets, FENOGLIDE® (fenofibrate) tablets. RELISTOR® oral tablet,
encapsulated bowel preparation and rifaximin for additional
indications are under development.
For full prescribing information and important safety
information on Salix products, including BOXED WARNINGS for
OSMOPREP, AZASAN, GLUMETZA and METOZOLV, please visit www.salix.com
where the Company promptly posts press releases, SEC filings and
other important information or contact the Company at 919
862-1000.
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 Salix at 919-862-1000. Follow us on Twitter
(@SalixPharma) and Facebook (www.facebook.com/SalixPharma).
Information on our Twitter feed, Facebook page and website is not
incorporated in our filings with the SEC.
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 two-cohort phase 2
clinical trial and a small molecule targeted imaging agent that has
completed dosing in a phase 2 trial. 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.
Additional information concerning Progenics and its business may
be available in press releases or other public announcements and
public filings made after this release.
For additional information, please visit www.progenics.com.
Information on or accessed through our website is not included in
the company's SEC filings. Follow us on LinkedIn.
Salix Disclosure Notice
Please Note: The statements provided herein that are not
historical facts are or might constitute projections and other
forward-looking statements regarding future events. 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 are just
predictions and are subject to known and unknown risks and
uncertainties that could cause actual events or results to differ
materially from expected results. Factors that could cause actual
events or results to differ materially from those described herein
include, among others: market acceptance for approved product
including new indications for RELISTOR; uncertainties as to the
ability to successfully complete the proposed Cosmo transaction in
accordance with its terms and in accordance with the expected
schedule; the possibility that competing offers will be made; the
possibility that various closing conditions for the proposed Cosmo
transaction may not be satisfied or waived, including that a
governmental entity may prohibit or refuse to grant any approval
required for the consummation of the proposed transaction; the
unpredictability of the duration and results of regulatory review
of New Drug Applications, Biologics License Agreements, and
Investigational NDAs; generic and other competition in an
increasingly global industry; litigation and 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 industry; the cost, timing and results of
clinical trials and other development activities involving
pharmaceutical products; post-marketing approval regulation,
including the ongoing Department of Justice investigation of
Salix’s marketing practices; revenue recognition and other critical
accounting policies; the need to acquire new products; changes in
tax laws or interpretations thereof; general economic and business
conditions; and other factors. Readers are cautioned not to place
undue reliance on the forward-looking statements included herein,
which speak only as of the date hereof. Salix does not undertake to
update any of these statements in light of new information or
future events, except as required by law. The reader is referred to
the documents that Salix files from time to time with the SEC.
Progenics Disclosure Notice
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 and other development
activities; the unpredictability of the duration and the results of
regulatory review of New Drug Applications and Investigational
NDAs; market acceptance for approved products; generic and other
competition; the possible impairment of, inability to obtain and
costs of obtaining intellectual property rights; and possible
safety or efficacy concerns, general business, financial and
accounting matters, litigation and other risks. More information
concerning 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 and Exchange Commission. Progenics is providing
the information in this press release as of its date and does not
undertake any obligation to update or revise it, whether as a
result of new information, future events or circumstances or
otherwise.
Salix Pharmaceuticals, Ltd.Adam C. DerbyshireExecutive Vice
President and Chief Financial Officer919-862-1000orG. Michael
FreemanAssociate Vice President, Investor Relations and Corporate
Communications919-862-1000orProgenicsMelissa Downs, Investor
Relations Manager914-789-2800
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