Collegium Pharmaceutical, Inc. (Nasdaq:COLL) announced today that
it has submitted a Supplemental New Drug Application (sNDA) to the
U.S. Food & Drug Administration (FDA) to enhance the label for
Xtampza® ER (oxycodone extended-release), an abuse-deterrent,
extended-release opioid, for the management of pain severe enough
to require daily, around-the-clock, long-term opioid treatment and
for which alternative treatment options are inadequate.
The sNDA includes comparative oral pharmacokinetic data from a
recently completed clinical study evaluating the effect of physical
manipulation by crushing Xtampza ER compared with the
abuse-deterrent version of OxyContin® (oxycodone hydrochloride
extended-release tablets) and a control (oxycodone hydrochloride
immediate-release)
The results for Xtampza ER, consistent with the data included in
Xtampza ER prescribing information, demonstrated that crushing
Xtampza ER prior to oral administration did not significantly
affect its drug release profile. The results for OxyContin
replicated the results from Collegium’s previously published
clinical study demonstrating that, in contrast to Xtampza ER,
crushing OxyContin accelerated its drug release profile making it
bioequivalent to immediate-release oxycodone. The sNDA
includes an amendment to the Xtampza ER prescribing information to
include comparative pharmacokinetic data for intact and crushed
OxyContin alongside the data for intact and crushed Xtampza ER.
Although Xtampza ER has abuse-deterrent properties, abuse by
injection and by the nasal route of administration, as well as by
the oral route is still possible.
About Collegium Pharmaceutical,
Inc.
Collegium is a specialty pharmaceutical company focused on
developing a portfolio of products that incorporate its proprietary
DETERx® technology platform for the treatment of chronic pain and
other diseases. The DETERx technology platform is designed to
provide extended-release delivery, unique abuse-deterrent
properties, and flexible dose administration options.
About Xtampza ER
Xtampza ER is Collegium’s first product utilizing the DETERx
technology platform. Xtampza ER is an abuse-deterrent,
extended-release, oral formulation of oxycodone approved by
the FDA for the management of pain severe enough to
require daily, around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with
opioids, even at recommended doses, and because of the greater
risks of overdose and death with extended-release opioid
formulations, reserve Xtampza ER for use in patients for whom
alternative treatment options (e.g., non-opioid analgesics or
immediate-release opioids) are ineffective, not tolerated, or would
be otherwise inadequate to provide sufficient management of
pain.
Xtampza ER is not indicated as an as-needed (prn) analgesic.
The Full Prescribing Information for Xtampza ER contains the
following Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4
INTERACTION
Addiction, Abuse, and Misuse Xtampza ER
exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death.
Assess each patient’s risk prior to prescribing Xtampza ER and
monitor all patients regularly for the development of these
behaviors or conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may
occur with use of Xtampza ER. Monitor for respiratory
depression, especially during initiation of Xtampza ER or following
a dose increase.
Accidental Ingestion Accidental ingestion of
even one dose of Xtampza ER, especially by children, can result in
a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal
Syndrome Prolonged use of Xtampza
ER during pregnancy can result in neonatal opioid withdrawal
syndrome, which may be life-threatening if not recognized and
treated, and requires management according to protocols developed
by neonatology experts. If opioid use is required for a prolonged
period in a pregnant woman, advise the patient of the risk of
neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
Cytochrome P450 3A4 Interaction The
concomitant use of Xtampza ER with all cytochrome P450 3A4
inhibitors may result in an increase in oxycodone plasma
concentrations, which could increase or prolong adverse drug
effects and may cause potentially fatal respiratory depression. In
addition, discontinuation of a concomitantly used cytochrome P450
3A4 inducer may result in an increase in oxycodone plasma
concentration. Monitor patients receiving Xtampza ER and any CYP3A4
inhibitor or inducer.
IMPORTANT SAFETY INFORMATION
Xtampza ER is contraindicated in patients with: significant
respiratory depression; acute or severe bronchial asthma in an
unmonitored setting or in the absence of resuscitative equipment;
known or suspected gastrointestinal obstruction, including
paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to
oxycodone.
Xtampza ER contains oxycodone, a Schedule II controlled
substance. As an opioid, Xtampza ER exposes users to the risks of
addiction, abuse, and misuse. As extended-release products, such as
Xtampza ER, deliver the opioid over an extended period of time,
there is a greater risk for overdose and death due to the larger
amount of oxycodone present.
Potential serious adverse events caused by opioids include
addiction, abuse, and misuse, life-threatening respiratory
depression, neonatal opioid withdrawal syndrome, risks of
concomitant use or discontinuation of cytochrome P450 3A4
inhibitors and inducers, risks due to interactions with central
nervous system depressants, risk of life-threatening respiratory
depression in patients with chronic pulmonary disease or in
elderly, cachectic, or debilitated patients, adrenal insufficiency,
severe hypotension, risks of use in patients with increased
intracranial pressure, brain tumors, head injury, or impaired
consciousness, risks of use in patients with gastrointestinal
conditions, risk of use in patients with seizure disorders,
withdrawal, risks of driving and operating machinery, and
laboratory monitoring.
The most common AEs (>5%) reported by patients in the Phase 3
clinical trial during the titration phase were: nausea
(16.6%), headache (13.9%), constipation (13.0%), somnolence (8.8%),
pruritus (7.4%), vomiting (6.4%), and dizziness (5.7%).
For Important Safety Information visit including full
prescribing information
visit: http://www.xtampzaer.com/
Forward-Looking Statements This press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. We may, in some
cases, use terms such as "predicts," "believes," "potential,"
"proposed," "continue," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "should" or other
words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from the
company's current expectations. Management's expectations and,
therefore, any forward-looking statements in this press release
could also be affected by risks and uncertainties relating to a
number of other factors, including the following: our ability to
commercialize our products and product candidates; the existence of
any patent infringement or similar litigation relating to any of
our products or product candidates, and costs and delays associated
with such litigation; the size and growth potential of the markets
for our product and product candidates, and our ability to service
those markets; our ability to develop sales and marketing
capabilities, whether alone or with potential future collaborators;
the rate and degree of market acceptance of our product and product
candidates; the success, cost and timing of our product development
activities, studies and clinical trials; the success of competing
products that are or become available; and our expectations
regarding our ability to obtain and adequately maintain sufficient
intellectual property protection for our product candidates. These
and other risks are described under the heading "Risk Factors" in
our Annual Report on Form 10-K for the year ended December 31,
2015, and those risks described from time to time in other reports
which we file with the SEC. Any forward-looking statements
that we make in this press release speak only as of the date of
this press release. We assume no obligation to update our
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Contact:
Douglas Carlson
Vice President, Corporate Development
dcarlson@collegiumpharma.com
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