DETERx® microsphere technology: designed to help address a widespread challenge in chronic pain treatment1-3

  • Unintentional Misuse
  • DETERx & Manipulation Resistance

Misuse of opioids is not always intentional2

Lack of awareness may lead patients to manipulate their medication

~2/3 of surveyed patients with chronic pain didn't think that cutting, crushing, or grinding medication changed the way it worked2*

Misuse was estimated in ~25% of patients taking opioid medication in a systematic review3†

Unintentional misuse may put patients at risk

Manipulation of some ER opioids can lead to the rapid release and absorption of a potentially fatal dose4

Because no medication alone provides a guaranteed solution, Collegium is committed to helping address the problem of opioid abuse and misuse. Learn more about Collegium’s mission.

DETERx technology is engineered for manipulation resistance

However, abuse of Xtampza ER by injection, by the nasal route of administration, and by the oral route is still possible

*A total of 1021 patients (mean age: 56 years) with chronic pain completed an online survey. Of the patients surveyed, 10% stated they sometimes or always cut, crush, or grind their analgesic medication. When asked why, 85% answered ‘to make it easier to swallow.’ When asked if cutting, crushing, or grinding opioid medications caused any changes in the way these medications worked, 65% answered ‘No.’ Patients were diagnosed with multiple chronic pain conditions; the most common were back pain (75%), joint pain (64%), headaches (39%), and fibromyalgia (39%).2

In a systematic review and data synthesis of 38 studies to clarify and calculate prevalence estimates, ‘misuse’ was documented in approximately 1 in 4 or 1 in 5 patients (actual mean percentage range: 21.7%-29.3%). ‘Misuse’ was defined as: opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects.3

References

1. Xtampza ER [prescribing information]. Canton, MA: Collegium Pharmaceutical, Inc; 2016. 2. Pergolizzi JV Jr, Taylor R Jr, Nalamachu S, et al. Challenges of treating patients with chronic pain with dysphagia (CPD): physician and patient perspectives. Curr Med Res Opin. 2014;30:191-202. 3. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systemic review and data synthesis. Pain. 2015;156:569-576. 4. US Department of Health and Human Services. Food and Drug Administration MedWatch safety information. www.fda.gov/Safety/MedWatch/SafetyInformation/ucm396503.htm. Updated May 18, 2014. Accessed September 1, 2016.

DETERx technology makes the formulation more difficult to manipulate1

A proprietary formulation combining an oxycodone base with inactive ingredients to form a lipophilic salt1,4

  • The chemical properties of this lipophilic salt permit homogenous distribution of the active drug in each waxy microsphere4

Click below to watch a short video about proprietary DETERx technology:

DETERx technology is designed to avoid rapid increases in plasma concentrations from1:

  • Crushing

    Crushing

  • Chewing

    Chewing

  • Snorting

    Snorting

Also resists:

  • Injection

    Injection

    • Microspheres solidify within a needle and make it difficult to expel with injection1,4
  • Extraction

    Extraction

    • Attempts to extract oxycodone using a variety of household solvents are resisted by microspheres1
warning
Although the results of the oral human abuse potential study showed a difference in the Drug Liking endpoint, there was no statistically significant reduction in the response to Take Drug Again. Therefore, it cannot be concluded that Xtampza ER has physicochemical properties that are expected to reduce abuse via the oral route. Abuse of Xtampza ER by injection, by the nasal route of administration, and by the oral route is still possible. The use of any opioid may result in serious, life-threatening, or fatal respiratory depression, even when used as recommended

References

1. Xtampza ER [prescribing information]. Canton, MA: Collegium Pharmaceutical, Inc; 2016. 2. Pergolizzi JV Jr, Taylor R JR, Nalamachu S, et al. Challenges of treating patients with chronic pain with dysphagia (CPD): physician and patient perspectives. Curr Med Res Opin. 2014;30:191-202. 3. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systemic review and data synthesis. Pain. 2015;156:569-576. 4. US Food and Drug Administration. FDA advisory committee briefing document: Xtampza ER (extended-release oxycodone). www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm461640.pdf. Published September 11, 2015. Accessed April 7, 2016.

INDICATIONS AND USAGE

Xtampza® ER (oxycodone) is indicated 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 (eg, 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

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; 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

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

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

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.

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

Laboratory Monitoring

ADMINISTRATION WITH FOOD:

ADVERSE REACTIONS:

Please see full Prescribing Information, including Boxed Warning and Medication Guide.