Full Press Release Details
STOUGHTON, Mass., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that eight poster presentations highlighting data regarding its diversified pain portfolio will be presented at PAINWeek Conference 2024, being held in Las Vegas, NV, from September 3–6, 2024.
“Collegium is proud to present new real-world data at PAINWeek 2024 as part of our commitment to leading with science and responsible pain management,” said Thomas Smith, M.D., Chief Medical Officer of Collegium. “The eight posters demonstrate the clinical and population health impact of our meaningfully differentiated pain portfolio and provide important insights for healthcare decision makers who treat people with pain. We welcome opportunities to share clinical and real-world data with the medical community as we advance our mission to improve the lives of people living with serious medical conditions.”
The following posters will be available and on display to attendees in the Exhibit Hall from 10:30 a.m. PT on Wednesday, September 4, 2024, to 2:45 p.m. PT on Friday, September 6, 2024.
Poster Presentations:
| Poster Title: | Healthcare Costs and Resource Use among Chronic Low Back Pain Patients Treated with Belbuca® or Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims Analysis |
| Authors: | Vladimir Zah, D.Phil.; Filip Stanicic, M.Pharm, MSC; Dimitrije Grbic, M.Pharm., Ph.D. |
| Poster Title: | Treatment Characteristics and Dosing Patterns in Chronic Low Back Pain Patients Treated with Belbuca® and Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims Analysis |
| Authors: | Filip Stanicic, M.Pharm., MSC; Vladimir Zah, D.Phil,; Dimitrije Grbic, M.Pharm., Ph.D. |
| Poster Title: | Safety and Tolerability of Schedule III Buprenorphine and Oral Schedule II Opioid Treatment in Chronic Low Back Pain Patients: A Retrospective US Medicare Claims Analysis |
| Authors: | Dimitrije Grbic, M.Pharm., Ph.D.; Filip Stanicic, M.Pharm., MSC; Vladimir Zah, D.Phil, |
| Poster Title: | Comparison of Nonmedical Use of Buprenorphine Products for Analgesia Compared to Other Opioid Medications in Adults Evaluated for Substance Use with the Addiction Severity Index-Multimedia Version (ASI-MV®) |
| Authors: | Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. |
| Poster Title: | Exposures Reported to US Poison Centers Involving Buprenorphine Products for Analgesia Compared to Other Opioid Medications |
| Authors: | Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. |
| Poster Title: | A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration |
| Authors: | Lynn Webster, M.D.; Matthew Maga, Ph.D. |
| Poster Title: | Nonmedical Use and Route of Administration of XTAMPZA® ER versus Other Oxycodone Medications (Extended- and Immediate-Release) in Adults Evaluated for Substance Use with the Addiction Severity Index-Multimedia Version (ASI-MV®) |
| Authors: | Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. |
| Poster Title: | Curbing Opioid Abuse: Real-World Evidence of Abuse-Deterrent Formulations |
| Authors: | Lynn Webster, M.D.; Jeff Gudin, M.D. |
For more information on PAINWeek Conference 2024, visit: https://www.painweek.org/.
Xtampza® ER (oxycodone) extended-release capsules, CII, Nucynta® ER (tapentadol) extended-release tablets, CII, and Nucynta® (tapentadol) tablets, CII, can be abused or misused, and carry a risk of addiction. These products are intended for use only in appropriate pain patients and only when other treatment alternatives are inadequate. Use of Xtampza® ER, Nucynta® ER and Nucynta® can result in serious, life-threatening or fatal respiratory depression, even when used exactly as prescribed. See Important Safety Information, including Boxed Warning on addiction, abuse, and misuse and other serious risks regarding each of these three products at the end of this press release.
About Collegium Pharmaceutical, Inc.
Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com.
INDICATIONS AND USAGE
Xtampza® ER (oxycodone) is:
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them.
A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Not for use to treat pain that is not around-the-clock.
IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER
| WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); 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. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety. |
| 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 information about Xtampza ER:
Get emergency help or call 911 right away if you take too much Xtampza ER (overdose). When you first start taking Xtampza ER, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an overdose.
Taking Xtampza ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your Xtampza ER. They could die from taking it. Selling or giving away Xtampza ER is against the law.
Store Xtampza ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take Xtampza ER if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage, or have narrowing of the stomach or intestines.
Before taking Xtampza ER, tell your healthcare provider if you have a history of:
head injury, seizures
liver, kidney, thyroid problems
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of Xtampza ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Not recommended during treatment with Xtampza ER. It may harm your baby.
living in a household where there are small children or someone who has abused street or prescription drugs.
taking prescription or over-the counter medicines, vitamins, or herbal supplements. Taking Xtampza ER with certain other medicines can cause serious side effects that could lead to death.
When taking Xtampza ER:
Do not change your dose. Take Xtampza ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
If you cannot swallow Xtampza ER capsules, see the detailed Instructions for Use in the Medication Guide.
Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.
Swallow Xtampza ER whole. Do not snort, or inject Xtampza ER because this may cause you to overdose and die.
The contents of the Xtampza ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking Xtampza ER without talking to your healthcare provider.
Dispose of expired, unwanted or unused Xtampza ER by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking Xtampza ER, DO NOT:
Drive or operate heavy machinery, until you know how Xtampza ER affects you. Xtampza ER can make you sleepy, dizzy, or light-headed.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Xtampza ER may cause you to overdose and die.
The possible side effects of Xtampza ER are:
constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of Xtampza ER. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov.
See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at XtampzaER.com/PI. Speak to your healthcare provider if you have questions about Xtampza ER.
BELBUCA® (buprenorphine buccal film) CIII is:
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Not for use to treat pain that is not around-the-clock.
IMPORTANT SAFETY INFORMATION about BELBUCA®
| WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse BELBUCA 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 BELBUCA, and monitor regularly for these behaviors and conditions. Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety. |
| Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and poses a significant risk of overdose and death. Accidental Exposure Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine. Neonatal Opioid Withdrawal Syndrome Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. 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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. |
Important information about BELBUCA:
Get emergency help or call 911 right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law.
Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not use BELBUCA if you have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.
Before taking BELBUCA, tell your healthcare provider if you have a history of:
head injury, seizures
heart rhythm problems (long QT syndrome)
liver, kidney, thyroid problems
tooth problems, including a history of cavities
pancreas or gallbladder problems
abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
Tell your healthcare provider if you are:
pregnant or planning to become pregnant. Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby.
Living in a household where there are small children or someone who has abused street or prescription drugs.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death.
When taking BELBUCA:
Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.
See the detailed Instructions for Use for information about how to apply BELBUCA.
Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.
After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.
After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA.
Avoid touching or moving the buccal film with your tongue or fingers.
Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.
Call your healthcare provider if the dose you are using does not control your pain.
Do not stop using BELBUCA without talking to your healthcare provider.
Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While using BELBUCA DO NOT:
Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die.
The possible side effects of BELBUCA are:
nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of BELBUCA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Please see full Prescribing Information, including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide or speak to your healthcare provider if you have questions about BELBUCA.