Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Assess each patient’s risk prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions. Xtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. WARNING: ADDICTION, ABUSE, AND MISUSE LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION NEONATAL OPIOID WITHDRAWAL SYNDROME and CYTOCHROME P450 3A4 INTERACTION
Xtampza er full#
The Full Prescribing Information for Xtampza ER contains the following Boxed Warning: Xtampza ER is not indicated as an as-needed (prn) analgesic. 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.īecause 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 Collegium’s first product utilizing the DETERx technology platform. The DETERx technology platform is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options. “Our team has built an integrated commercial model to leverage the unique attributes of Xtampza ER across the retail, out-patient setting, institutional channel and long term care channel.”Ĭollegium is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products that incorporate its proprietary DETERx ® technology platform for the treatment of chronic pain and other diseases. Key stakeholders, including healthcare providers and payers, have responded favorably to the differentiated attributes of the Xtampza ER label,” said Barry Duke, Chief Commercial Officer. “We are prepared and incredibly excited to launch Xtampza ER. In addition, an institutional focused sales force of specialty sales representatives will target hospitals and long term care facilities. The Xtampza ER commercial launch will be supported by a field sales force of approximately 120 retail sales professionals with a primary focus on pain specialists. Xtampza ER will provide clinicians with another treatment option for these patients.” “We are committed to supporting responsible, appropriate prescribing for patients suffering from chronic pain who don’t have alternative non-opioid treatment options.
![xtampza er xtampza er](http://concentricstaging.com/clients/collegium/Xtampza/Xtampza-Patient/hcp/assets/img/nasal-abuse/nasal-abuse-compare-chart-mobile.png)
“The launch of Xtampza ER is a culmination of many important milestones for Collegium that span the last several years,” said Michael Heffernan, CEO of Collegium. The Xtampza ER label supports alternate administration options, including, sprinkling the capsule contents on soft foods or into a cup, and then directly into the mouth, or through a gastrostomy or nasogastric feeding tube.
![xtampza er xtampza er](https://www.xtampzaer.com/assets/img/seal.png)
While abuse of Xtampza ER is still possible, FDA has determined that the product has abuse-deterrent properties. Xtampza ER is Collegium’s first product utilizing its proprietary DETERx ® technology platform, and is designed to provide adequate pain control while maintaining its extended-release drug release profile after being subjected to common methods of abuse and accidental misuse. Food and Drug Administration ( 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. (Nasdaq:COLL) today announced the commercial launch of Xtampza ® ER (oxycodone) extended-release (ER) capsules in the United States. New Extended-Release Opioid with Abuse-Deterrent PropertiesĬANTON, Mass., J(GLOBE NEWSWIRE) - Collegium Pharmaceutical, Inc.