CANTON, Mass., Oct. 05, 2016 (GLOBE NEWSWIRE) -- 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
