Collegium Announces Publication of “Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza® ER” in Pain Medicine
October 26, 2020 at 08:00 AM EDT
STOUGHTON, Mass., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today announced a publication titled, “Postmarketing Analysis of Misuse, Abuse and Diversion of Xtampza ER,” was published in the peer-reviewed medical journal, Pain Medicine.
“As a company committed to being the leader in responsible pain management, we are encouraged by findings in this analysis which found that over the first 3 years of Xtampza ER’s launch, when prescriptions increased 50-fold, cases from poison centers, substance abuse treatment centers and a diversion monitoring program were infrequent and did not increase, and Xtampza ER had low rates of misuse, abuse and diversion relative to specified prescription opioid categories,” said Richard Malamut, M.D., Executive Vice President and Chief Medical Officer of Collegium. “The publication of the postmarketing analysis of real-world evidence related to Xtampza ER provides data that can enrich the scientific and clinical evaluation of abuse deterrent formulations. We remain committed to postmarketing studies and surveillance and look forward to continuing to share Xtampza ER real-world evidence with the FDA and the medical community.”
The objective of the analysis was to evaluate abuse, misuse and diversion of Xtampza ER (oxycodone) extended-release capsules, CII. The publication presents certain real-world evidence related to abuse, misuse and diversion of Xtampza ER assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS®) system data sources. Xtampza ER was compared to immediate-release oxycodone, other abuse-deterrent formulation extended-release products, and non-abuse-deterrent formulation extended-release products. Because of the inherently less controlled nature of the data generated in real-world studies, it is critical to interpret them with caution. In particular, and among other issues, in observational studies that leverage existing data rather than prospectively collected data, the impact of confounding factors on the findings may be difficult to ascertain. The data in this publication represent a single snapshot in time and rates of abuse as reflected in these data may change as changes occur in the social environment and legal, regulatory and medical landscape.
Xtampza ER has abuse-deterrent properties in the FDA approved product label, however, abuse of Xtampza ER by injection and by the oral and nasal routes of administration is still possible. As an opioid, Xtampza ER exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Xtampza ER. Addiction can occur at recommended dosages and if the drug is misused or abused. Patients are to be assessed for the risk for opioid addiction, abuse, or misuse prior to prescribing Xtampza ER, and all patients receiving Xtampza ER monitored for the development of these behaviors or conditions. While the analysis reported in this publication contributes to an understanding of the relative rates of abuse of various opioid products, nothing in the findings should be construed as suggesting that Xtampza ER does not have a high potential for addiction, abuse, or misuse. Please see full Prescribing Information for Xtampza ER including Boxed Warning on addiction, abuse, and misuse.
The publication can be found here: Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza ER
About Collegium Pharmaceutical, Inc.
Collegium is a specialty pharmaceutical company committed to being the leader in responsible pain management. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the company’s website at www.collegiumpharma.com.
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.
INDICATIONS AND USAGE
WARNINGS AND PRECAUTIONS:
For further information on the REMS and a list of accredited REMS CME/CE, call 1-800-503-0784, or visit www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.
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
The use of Xtampza ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease: Xtampza ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive, including apnea, even at recommended dosages of Xtampza ER.
Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
Monitor such patients closely, particularly when initiating and titrating Xtampza ER and when Xtampza ER is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.
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
Risks of Driving and Operating Machinery
ADMINISTRATION WITH FOOD:
Please see full Prescribing Information, including Boxed Warning at xtampzaer.com.
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," "forecasts," "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. Examples of forward-looking statements contained in this press release include, among others, statements regarding financial guidance for Xtampza ER and Nucynta Franchise revenues, total operating expenses, current and future market opportunities for our products and our assumptions related thereto. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements 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 impact of the COVID-19 pandemic on our ability to conduct our business, reach our customers, and supply the market with our products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to obtain and maintain regulatory approval of our products and any product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product; the size of the markets for our products and product candidates, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products and product candidates; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us, including litigation with Purdue Pharma, L.P. and Teva Pharmaceuticals USA, Inc.; the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid medications; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings 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.