CANTON, Mass., Nov. 07, 2017 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) announced today that
the U.S. Food and Drug Administration (FDA) approved its Supplemental New Drug Application (sNDA) 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.
With approval of the sNDA, the updated label for Xtampza ER includes three main changes:
- OxyContin Comparative Data - The addition of comparative oral pharmacokinetic data, collected in
two completed clinical studies 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
immediate-release (IR)),
- Oral Human Abuse Potential Study - Results of an oral human abuse potential study comparing
intact and manipulated Xtampza ER to oxycodone IR were added to the label. This study demonstrated that the oral administration
of chewed and intact Xtampza ER in the fasted state was associated with statistically lower mean Drug Liking and Take Drug Again
Visual Analogue Scale scores compared with crushed immediate-release oxycodone. In addition, the Drug Liking and Take Drug Again
scores were similar for Xtampza ER taken in the intact and chewed states.
- Oral Abuse Deterrent Claim - The addition of an oral abuse deterrent claim into the label that
indicates that Xtampza ER has physicochemical properties that are expected to reduce abuse via the oral route. Xtampza ER
is the only single agent oxycodone with this labelling.
“The FDA approval of the sNDA is a major milestone for Collegium. With the addition of comparative pharmacokinetic
data with OxyContin and an oral abuse deterrent claim, Xtampza ER is the only single agent oxycodone with oral, intranasal and
intravenous abuse deterrent labelling,” said Michael Heffernan, CEO of Collegium. “Collegium is committed to supporting
responsible, appropriate opioid prescribing for only those patients suffering from chronic pain who don’t have alternative
non-opioid treatment options”.
“The data added to the Xtampza ER label has important implications for clinicians and patients when considering
safety as well as abuse, misuse and diversion,” said Dr. Jeff Gudin, Director of Pain Management and Palliative Care at the
Englewood Hospital and Medical Center in New Jersey.
Management will discuss the sNDA approval on its Third Quarter Conference call on Wednesday, November 8, 2017 at
4:30 p.m. Eastern Time.
Conference Call Information:
To access the conference call, please dial (888)698-6931 (U.S.) or (805)905-2993 (International) and refer to
Conference ID: 668-9689. An audio webcast will be accessible from the Investor Relations section of the Company’s website:
http://www.collegiumpharma.com/. An archived webcast will be available on
the Company’s website approximately two hours after the event.
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; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS DEPRESSANTS
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.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in
profound sedation, respiratory depression, coma, and death.
• Reserve concomitant prescribing of Xtampza ER and benzodiazepines or other CNS depressants for use in patients for
whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.
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 from concomitant use with benzodiazepines or other CNS 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 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 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; our ability to retain key and 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
[email protected]
