FDA Office of Drug Evaluation III Approves Salix’s Request that the FDA Approve the RELISTOR® Subcutaneous Injection sNDA for the Treatment of Opioid-induced Constipation in Patients with Chronic Non-cancer Pain
RALEIGH, N.C. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals
(NASDAQ:PGNX) today announced that the Food and Drug Administration (FDA
or Agency) has informed Salix that RELISTOR®
(methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the
treatment of opioid-induced constipation (OIC) in patients taking
opioids for chronic non-cancer pain can be approved on the data
submitted in the sNDA.
About Viagra Capsules (Sildenafil Citrate) with free prescription The FDA Office of Drug Evaluation III responded
to the Company’s formal appeal filed in response to the Complete
Response Letter (CRL) of July 27, 2012 to the supplemental NDA (sNDA)
for RELISTOR.
Buy Viagra Professional (Sildenafil Citrate) with no prescription The Agency’s letter stated that, “Salix’s request that FDA
approve the supplemental NDA for RELISTOR subcutaneous injection for the
treatment of opioid-induced constipation in patients with chronic
non-cancer pain based on the submitted data is granted.”
In regard to the RELISTOR sNDA the Agency has directed Salix to work
with and submit certain information to the Division of Gastroenterology
and Inborn Errors Products (DGIEP).
Buy Zebeta (Bisoprolol, Fumarate) with no prescription Salix intends to submit the
requested information over the next several weeks.
About Coapprovel with no Rx The requested
information includes: proposed product labeling and a proposal(s) for
one or more post-marketing observational cohort studies designed to
assess the relative incidence of Major Adverse Cardiovascular Events
(MACE) among chronic non-cancer pain patients initiating RELISTOR via
subcutaneous injection for OIC versus a comparator cohort.
This request for a proposal for a post-marketing observational study is
in accordance with recommendations of the June 11-12, 2014 meeting of
the Anesthetic and Analgesic Drug Product Advisory Committee.
Buy Nasal Spray online Salix will
work with the DGIEP in an effort to provide information to the Division
that will enable the Division to approve RELISTOR for use by patients
with chronic non-cancer pain and experiencing OIC.
“The approval and availability of RELISTOR for this expanded use will be
an important and welcomed advancement for treating the underlying cause
of OIC experienced by many patients taking opioids for chronic
non-cancer pain,” stated Bill Forbes, Executive Vice President, Medical,
Research and Development and Chief Development Officer, Salix.
http://webmdhelp.wordpress.com
“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. RELISTOR is a peripherally acting mu-opioid receptor
antagonist (PAMORA) designed to counteract the constipating effects of
opioid pain medications without affecting their ability to relieve pain.
We intend to submit the requested information to the FDA in the next
several weeks. We look forward to working with the GI Division to gain
marketing approval for this important therapy that works precisely to
address the underlying cause of OIC.”
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 are on 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. In clinical trials, approximately 50%
of patients experienced relief of OIC in as little as 4 hours. RELISTOR
is the only PAMORA currently approved by the FDA for the treatment of
OIC in patients with advanced illness receiving palliative care when the
response to laxatives has been insufficient.
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 .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 .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 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, 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®, 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. UCERIS (budesonide) rectal foam, RELISTOR®, LUMACAN™,
RUCONEST®, RHB-106 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 .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 .salix.com
or contact Salix at 919-862-1000. Follow us on Twitter (@SalixPharma)
and Facebook (.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 and
a small molecule targeted imaging agent, both in phase 2 clinical
trials. 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 .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.
Salix Disclosure Notice
As previously announced on July 8, 2014, Salix, Cosmo Pharmaceuticals
S.p.A. and Irish domiciled Cosmo Technologies Limited entered into an
Agreement and Plan of Merger and Reorganization, pursuant to which a
subsidiary of Cosmo Technologies Limited will merge with and into Salix,
with Salix as the surviving entity, and Salix will become an indirect,
wholly-owned subsidiary of Cosmo Technologies Limited, which will change
its name to Salix Pharmaceuticals, plc.
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: uncertainties as to the ability to
successfully complete the proposed 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 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; market acceptance for approved products; 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: 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.
