Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that
it will present data on Xtampza® ER, an extended-release oral
formulation of oxycodone with abuse-deterrent properties, at the
33rd Annual American Academy of Pain Medicine Meeting on March 16th
in Orlando.
The poster titled, “Converting Subjects with Chronic Pain from
Immediate-Release Oxycodone to Xtampza ER, an Extended-Release,
Abuse-Deterrent Formulation,” is a post hoc analysis of data from
patients with chronic low back pain previously uncontrolled with
immediate-release oxycodone, who were converted to Xtampza ER as
part of a Phase 3 randomized withdrawal, double-blind,
placebo-controlled, enriched-enrollment, parallel-group,
multicenter, 12-week clinical study.
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 including full prescribing
information visit: http://www.xtampzaer.com/
Forward-Looking StatementsThis 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
obtain and maintain regulatory approval of our products and product
candidates, and any related restrictions, limitations, and/or
warnings in the label of an approved product; our plans to
commercialize our product candidates and grow sales of our
products; the size and growth potential of the markets for our
products and product candidates, and our ability to service those
markets; the success of competing products that are or become
available; our ability to obtain reimbursement and third-party
payor contracts for our products; the costs of commercialization
activities, including marketing, sales and distribution; our
ability to develop sales and marketing capabilities, whether alone
or with potential future collaborators; the rate and degree of
market acceptance of our products and product candidates; changing
market conditions for our products and product candidates; the
outcome of any patent infringement or other litigation that may be
brought against us, including litigation with Purdue Pharma, L.P.;
our ability to attract collaborators with development, regulatory
and commercialization expertise; the success, cost and timing of
our product development activities, studies and clinical trials;
our ability to obtain funding for our operations; regulatory
developments in the United States and foreign countries; our
expectations regarding our ability to obtain and adequately
maintain sufficient intellectual property protection for our
products and product candidates; our ability to operate our
business without infringing the intellectual property rights of
others; the performance of our third-party suppliers and
manufacturers; our ability to comply with stringent U.S. and
foreign government regulation in the manufacture of pharmaceutical
products, including U.S. Drug Enforcement Agency compliance; the
loss of key scientific or management personnel; our expectations
regarding the period during which we qualify as an emerging growth
company under the JOBS Act; and the accuracy of our estimates
regarding expenses, revenue, capital requirements and need for
additional financing. 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, 2016, 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:
Alex Dasalla
adasalla@collegiumpharma.com
Collegium Pharmaceutical (NASDAQ:COLL)
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