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Last update 03 Apr 2025

Buprenorphine Hydrochloride

Last update 03 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryBuprenorphine Hydrochloride, a drug approved in US on December 29, 1981, is manufactured by Indivior and is primarily used to manage pain that requires opioid analgesics and for which alternative treatments are insufficient. Buprenorphine works as a partial agonist at the mu-opioid receptor and as an antagonist at the kappa-opioid receptor. Its slow rate of dissociation from its receptor, which has been observed in vitro studies, accounts for its longer duration of action compared to morphine, its unpredictability of reversal by opioid antagonists, and its low level of manifest physical dependence. Buprenex is an important drug for pain management and has been widely used in the medical field.

Drug Type

Small molecule drug

Synonyms

BUP-XR, Buprenorphine hydrochloride (JP17/USP), Buprenorphine Transdermal Patch

+ [39]

Target

κ opioid receptor x μ opioid receptor

Action

antagonists, agonists

Mechanism

κ opioid receptor antagonists(Kappa opioid receptor antagonists), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Opioid abuseChronic PainOpium Dependence+ [7]

Inactive Indication

Arthritis PainBack PainDiabetes Mellitus, Type 2+ [13]

Originator Organization

Indivior PLC

Active Organization

Indivior, Inc.

Paladin Labs, Inc.L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.

+ [8]

Inactive Organization

National Institute on Drug Dependence,Peking University

Purdue Pharma LP

The University of California, San Francisco

+ [10]

Drug Highest PhaseApproved

First Approval Date

United States (29 Dec 1981),

Pain

RegulationOrphan Drug (United States)

Structure/Sequence

Molecular FormulaC29H42ClNO4

InChIKeyUAIXRPCCYXNJMQ-RZIPZOSSSA-N

CAS Registry53152-21-9

125

Clinical Trials associated with Buprenorphine Hydrochloride

NCT05270434

/ Enrolling by invitationNot ApplicableIIT

Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Pancreatitis with Pancreatic Stones.

This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.

Start Date25 Mar 2025

Sponsor / Collaborator

Changhai Hospital of Shanghai

NCT06316830

/ RecruitingPhase 2/3IIT

Randomized Clinical Trial of a 16 Mg Vs. 24 Mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People with Opioid Use Disorder

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Start Date06 Jan 2025

Sponsor / Collaborator

Rhode Island Hospital

[+1]

CTRI/2024/12/077742

/ Not yet recruitingNot ApplicableIIT

Comparative Analysis of Plasma Levels andSubjective Effects of Intravenous vs SublingualBuprenorphine: A Randomized, Double-Blind,Double Dummy Study. - NIL

Start Date01 Jan 2025

Sponsor / Collaborator-

100 Clinical Results associated with Buprenorphine Hydrochloride

100 Translational Medicine associated with Buprenorphine Hydrochloride

100 Patents (Medical) associated with Buprenorphine Hydrochloride

10,986

Literatures (Medical) associated with Buprenorphine Hydrochloride

01 Jun 2025·NEUROPHARMACOLOGY

Prenatal exposure to methadone or buprenorphine alters transcriptional networks associated with synaptic signaling in newborn rats

Article

Author: Nyberg, Henriette ; Bogen, Inger Lise ; Duale, Nur ; Andersen, Jannike Mørch

While the use of methadone or buprenorphine during pregnancy is beneficial for the mother's health compared to illicit opioid use, prenatal exposure to these medications may have adverse consequences for the unborn child. However, the underlying molecular mechanisms of prenatal opioid exposure on neurodevelopment remain poorly understood. Hence, this study aimed to investigate gene expression changes, focusing on synapse-related genes, in cerebral tissue from newborn rats prenatally exposed to methadone or buprenorphine. Female Sprague-Dawley rats were exposed to methadone (10 mg/kg/day), buprenorphine (1 mg/kg/day), or sterile water through osmotic minipumps during pregnancy. Total RNA was isolated from the cerebrum on postnatal day 2 and analyzed using RNA-sequencing. Analyses of differentially expressed genes (DEGs) and enriched biological processes were conducted to compare the gene expression profiles between treatment groups within each sex. Prenatal buprenorphine exposure resulted in 598 DEGs (333 up- and 265 downregulated) in males and 175 (75 up- and 100 downregulated) in females, while prenatal methadone exposure resulted in 335 DEGs (224 up- and 111 downregulated) in males and 201 (57 up- and 144 downregulated) in females. Gene ontology analyses demonstrated that enriched biological processes included synaptic signaling, immune responses, and apoptosis. Analysis of the DEGs using the synapse database SynGO revealed that males prenatally exposed to buprenorphine displayed the highest number of enriched synapse-related biological process terms. Understanding gene expression changes following prenatal methadone or buprenorphine exposure is crucial to uncover the mechanisms underlying behavioral alterations and to develop interventions to mitigate the impact of opioid exposure on neurodevelopment.

01 May 2025·DRUG AND ALCOHOL DEPENDENCE

Buprenorphine adherence among a prospective cohort of homeless-experienced adults with opioid use disorder

Article

Author: Kruse, Gina ; Sporn, Nora ; Hart, Katherine ; Wright, Joe ; Fine, Danielle R ; Baggett, Travis P ; Regan, Susan ; Gaeta, Jessie ; Critchley, Natalia

INTRODUCTION:

People experiencing homelessness face high rates of opioid-related mortality. Buprenorphine is a medication that reduces opioid-related mortality, but adherence to this medication among people experiencing homelessness is not well-documented. This study assessed buprenorphine adherence and identified factors associated with it in this high-risk population.

METHODS:

We conducted a prospective cohort study of English- and Spanish-speaking adults (≥18 years) enrolled in the Boston Health Care for the Homeless Program outpatient-based opioid treatment (OBOT) program from 1/6/2022-1/5/2023. Our primary outcome was buprenorphine adherence, measured by the percentage of days covered (PDC). We used multivariable linear regression to identify demographics, social determinants, and clinical characteristics independently associated with buprenorphine adherence.

RESULTS:

Of 139 participants, 23 % were female, 45 % were non-Hispanic White, 37 % were Hispanic, 13 % were non-Hispanic Black, and the mean age was 42 years. The mean PDC was 49.4 % over the 4-month follow-up period. Older age (beta=7.03 % per decade; 95 % CI=1.99 %-12.08 %), living in a residential treatment facility at baseline (vs. being unhoused; beta=14.6 %; 95 % CI=1.7 %-27.6 %), higher levels of baseline recovery (beta=0.77 % per one-point increase in the recovery score; 95 % CI=0.21 %-1.32 %), a higher maximum buprenorphine dose (>16mg vs. ≤16mg; beta=13.1 %; 95 % CI=2.4 %-23.9 %), and receiving extended-release buprenorphine (beta=18.1 %; 95 % CI=4.3 %-31.9 %) were independently associated with a greater PDC.

CONCLUSIONS:

Buprenorphine adherence in this cohort of homeless-experienced adults was approximately 50 % over 4 months. Proactive up-titration of buprenorphine dosing, consideration of extended-release formulation, and ensured access to buprenorphine in residential treatment settings may improve adherence in this marginalized population.

01 May 2025·Journal of substance use and addiction treatment

Living with chronic structural vulnerability: A biopsychosocial-structural formulation of a patient exhibiting “medical noncompliance” in the setting of historical trauma and social suffering

Article

Author: Iles-Shih, Matthew D ; Clifasefi, Seema L ; Collins, Shane P

BACKGROUND:

This qualitative case study explores the potential for operationalizing the social science framework of structural vulnerability through integrating it into the classic 4P model of biopsychosocial case formulation.

METHODS:

Through phenomenological analysis of data from a series of longitudinal in-depth interviews with the case study participant, a middle-aged Native American man recently initiated on buprenorphine-naloxone for opioid use disorder after undergoing below-the-knee leg amputation, the study developed a biopsychosocial-structural case formulation identifying predisposing, precipitating, perpetuating, and protective factors contributing to the participant's deteriorating health.

RESULTS:

Key findings from this case formulation facilitate reconceptualization of the participant's acute symptomology and high-risk behavior as manifestations of structural violence and historical trauma.

CONCLUSION:

Adopting the diachronic approach inherent to the 4P factor model allowed for temporal expansion of analysis, which emphasizes the cumulative and compounding health effects of living with chronic structural vulnerability.

321

News (Medical) associated with Buprenorphine Hydrochloride

27 Mar 2025

·www.globenewswire.com

Collegium to Present Real-World Data at PainConnect 2025, the American Academy of Pain Medicine’s Annual Meeting

STOUGHTON, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it will present four posters highlighting real-world patient data from its differentiated pain portfolio at PainConnect 2025, the American Academy of Pain Medicine (AAPM)’s Annual Meeting, being held in Austin, TX, from April 3-6, 2025. Among these, the poster titled “Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II Opioids” has been selected as one of the top abstracts. This distinction includes recognition in AAPM’s Pain Medicine Journal, where the abstract will also be published. “We are excited to present four posters with important real-world data from our differentiated pain portfolio at PainConnect 2025 and are grateful to AAPM for selecting our poster at its meeting as a top abstract. We expect these collective data to offer meaningful information for healthcare professionals who treat people with pain,” said Thomas Smith, M.D., Chief Medical Officer. “As the leader in responsible pain management, we also look forward to highlighting important aspects of our medicines as part of our unwavering commitment to the highest ethical standards.” The following posters will be presented to attendees on Friday, April 4 at the times listed below. Poster Title:Opioid Abuse Deterrent Formulations: Evaluation of Nonmedical Use of Other Prescription Opioid Substances and Routes of Administration in Adults Evaluated for Substance Use Treatment with the Addiction Severity Index-Multimedia Version (ASI-MV®)Authors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:00 – 11:05 a.m. CT Poster Title:Evaluating the Abuse Profile of Opioid Pain Medications by Their Controlled Substance Act Designated Schedule: A Systematic Review of Real-World EvidenceAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:05 – 11:10 a.m. CT Poster Title:Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II OpioidsAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Kaitlin Hartlage, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:10 – 11:15 a.m. CT Poster Title:Clinical Outcomes Translated to Healthcare Costs: Comparison of Buprenorphine Pain Medications with Schedule II Extended-Release OpioidsAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Kaitlin Hartlage, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:15 – 11:20 a.m. CT 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 DEPRESSANTSAddiction, Abuse, and MisuseBELBUCA 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, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, 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 ExposureAccidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine.Neonatal Opioid Withdrawal SyndromeProlonged 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 DepressantsConcomitant 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, seizuresheart rhythm problems (long QT syndrome)liver, kidney, thyroid problemstooth problems, including a history of cavitiespancreas or gallbladder problemsproblems urinatingabuse 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. 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 DEPRESSANTSAddiction, Abuse, and MisuseXtampza 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, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, 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 IngestionAccidental ingestion of even one dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.Neonatal Opioid Withdrawal SyndromeProlonged 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 InteractionThe 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 DepressantsConcomitant 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, seizuresliver, kidney, thyroid problemsproblems urinatingpancreas or gallbladder problemsabuse 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. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and recently acquired Jornay PM, a treatment for ADHD, establishing a presence in neuropsychiatry. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.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," "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 related to future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. 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, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to realize the anticipated benefits associated with the acquisition of Ironshore; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, 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; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; 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 (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 Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q 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. Investor Contacts:Ian KarpVice President, Investor Relationsir@collegiumpharma.com Danielle JesseDirector, Investor Relationsir@collegiumpharma.com Media Contact:Cheryl WheelerHead of Corporate Communicationscommunications@collegiumpharma.com

10 Mar 2025

·www.healthcareitnews.com

DEA role must be clearly defined in controlled substance Rx via telemedicine, expert cautions

The U.S. Drug Enforcement Administration has proposed draft guidance to establish a framework for prescribing controlled substances via telemedicine. The proposal introduces three types of special registrations. Telemedicine prescribing registration allows qualified practitioners to prescribe Schedule III-V controlled substances via telemedicine. Advanced telemedicine prescribing registration permits specialized practitioners, such as psychiatrists and hospice care physicians, to prescribe Schedule II-V controlled substances via telemedicine. And telemedicine platform registration enables online telemedicine platforms to dispense Schedule II-V controlled substances through registered practitioners. The guidance proposes allowing patients to receive a six-month supply of buprenorphine, used to treat opioid use disorder, through a telephone consultation with a provider. Subsequent prescriptions would require an in-person visit. Clinicians' responsibilities Practitioners would be required to conduct Prescription Drug Monitoring Program checks for the states where both the patient and the practitioner are located, as well as any other relevant states with PDMP reciprocity. Detailed records must be maintained for in-person evaluations, telehealth prescriptions and referrals. The proposal also includes safeguards for prescribing high-risk medications, such as Schedule II substances. These measures aim to expand patient access to controlled substances via telemedicine while implementing safeguards to prevent misuse and diversion. Dan Cohen, president of Adhere+, a vendor of remote therapeutic monitoring technology and services, says the DEA's draft language needs to be clarified that healthcare practitioners make treatment decisions – the DEA needs to limit its role to ensure patient safety and prevent misuse, not to dictate clinical decision making for practitioners. Clearly defining the role of the DEA "The concern here is about ensuring the role of the DEA is clearly defined when it comes to overseeing healthcare practitioners' treatment decisions, particularly in the context of prescribing Scheduled medications," Cohen explained. "The primary responsibility of healthcare practitioners – doctors, nurses, pharmacists, etc. – is to make clinical decisions based on their professional judgment, patient needs and medical guidelines. "If the DEA's role is not properly limited, there could be an overreach where the agency influences or even dictates how healthcare practitioners make these decisions, which could undermine the autonomy of medical professionals and potentially impact patient care," he continued. "The DEA's main mission should be to prevent drug misuse, addiction and illegal distribution while safeguarding patient safety. However, it should not be in the position of making clinical decisions or prescribing protocols for legitimate medical treatments." The language in any proposed regulation or legislation should therefore make it clear that while the DEA can enforce laws related to drug control and ensure that medications are prescribed and distributed safely and appropriately, healthcare practitioners remain the ones who make decisions about what treatment is appropriate for their patients, based on medical evidence, their expertise and individual patient needs, he said. Cohen contended that Congress make permanent COVID Public Health Emergency concessions, rather than renewing the concessions biannually. Several advantages to permanent concessions "Making the COVID-19 PHE concessions permanent, rather than renewing them biannually, could provide several advantages," he explained. "Doing so would provide stability and certainty, avoid legislative bottlenecks, enable continued access to healthcare, encourage long-term innovation, enable efficient use of resources, and continue lessons learned from the pandemic." On another note, telehealth encounters via electronic patient-reported outcomes (ePROs) should have clear, clinical content that develops over the treatment period for several key reasons, Cohen said. "This is because it tracks patient progress, improves clinical decision making, enhances patient-clinician communication, enables personalized treatment, improves outcome measurement, aids regulatory and reimbursement purposes, enables early identification of complications," he explained. "The lack of ePROs in a telehealth 'visit' compromises patient care," he continued. "Conversely, ePROs with clear, evolving clinical content are essential for monitoring patient progress, making informed clinical decisions, personalizing care, and improving overall treatment outcomes. They provide a comprehensive and accurate picture of the patient's health, which is critical for effective, evidence-based care." When AI helps with clinical decisions Cohen also offered views on how regulatory policies should be adapted and updated to allow for clinical decision making based in part on an artificial intelligence analysis of patients' ePROs data. Key regulatory policies for artificial intelligence and machine learning analysis of telehealth for the benefit of clinical decision making via evidence-based care include, Cohen detailed: Standards for AI/ML validation that offer clear guidelines for AI/ML models and continuous monitoring and updates. Data privacy and security regulations with robust data protection and transparency and consent management. Integration of AI/ML insights into clinical guidelines, including aligning AI/ML with evidence-based medicine and enabling clinical decision support systems. Definition of AI/ML's role in decision making, including clear delineation of AI's role and human oversight and accountability. Equity and mitigating of bias, including bias detection and mitigation and inclusion of diverse data. Clinical validation of AI-based decision tools, with post-market surveillance and clinical trials and testing. Patient-centered regulatory framework, including patient engagement and informed consent for AI use. Support for innovation and flexibility, with adaptive regulatory frameworks and fast-track for innovative AI tools. "For AI/ML analysis of ePROs data to be a valuable part of clinical decision making, regulatory policies need to ensure these tools are accurate, transparent, equitable, and integrated into a system that prioritizes patient safety and clinician oversight," Cohen said. "Establishing strong standards for validation, data security and bias mitigation, while fostering innovation and patient engagement, will be key to maximizing the benefits of AI/ML in healthcare." Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication. WATCH NOW: Mount Sinai's new CDIO offers an inside look at her very full plate

06 Mar 2025

·endpts.com

Novo Nordisk looks into starting GLP-1 drug trials for addiction

Novo Nordisk is considering investigating its GLP-1 therapies in the treatment of addictions, mirroring similar comments made by its major incretin rival Eli Lilly. Novo is already studying its GLP-1 agonist semaglutide, along with a couple of other drugs, in a Phase 2 trial in patients with alcoholic liver disease. But that is focused on the drugs’ effect on liver fibrosis, not the underlying addictive behavior. Now, the company has signaled its intent to specifically investigate whether the drugs can reduce alcohol or drug abuse. “We will … look into this and explore how we can help patients with addiction, potentially, with GLP-1,” Novo’s head of development Martin Holst Lange said on a media call Thursday. “Given the unmet need that we see, [treating addiction] is also interesting to us.” Lange added that application of GLP-1 medication to these diseases would have to be addressed in a scientific and rigorous way, to see “the potential impact” of GLP-1s. The company has not as yet made concrete plans for addiction trials but any such studies would almost certainly test semaglutide, the molecule behind its diabetes med Ozempic and obesity therapy Wegovy, both of which are megablockbusters. The company’s main rival in the incretin space, Eli Lilly, has been mulling a similar move for some time, though it has yet to start clinical trials. So far, most studies of GLP-1s in addiction have come from academia, and have largely been observational rather than having a more rigorous interventional design. For instance, a trial looking at the medical records of more than 220,000 patients with alcohol use disorder (AUD) found that those taking the GLP-1s semaglutide or liraglutide (branded as Victoza) for comorbid obesity or diabetes had a “markedly reduced risk” of hospitalizations caused by either AUD or substance abuse. This risk reduction was lower than that seen with officially approved AUD medications. Another observational trial found that semaglutide was associated with reduced opioid overdose risk in patients with both opioid use disorder and type 2 diabetes. The only medications currently approved for treating addictions tend to aim at reducing withdrawal symptoms for patients quitting opioid drugs, such as methadone and buprenorphine. Nothing is so far available to reduce cravings for alcohol or drugs, though companies such as Indivior are conducting research here.

Phase 2

100 Deals associated with Buprenorphine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00836	Buprenorphine Hydrochloride	N07BC01 N02AE01	DB00921

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Opioid abuse	Canada	Knight Therapeutics, Inc.	18 Apr 2018
Chronic Pain	Canada	Paladin Labs, Inc.	21 Jun 2017
Opium Dependence	France	RB Pharmaceuticals Ltd.	02 Nov 1999
Substance-Related Disorders	China	Qinghai Pharmaceutical Factory Co. Ltd.	01 Jan 1994
Anesthesia	Japan	Otsuka Pharmaceutical Co., Ltd.	27 May 1983
Cancer Pain	Japan	Otsuka Pharmaceutical Co., Ltd.	27 May 1983
Pain, Postoperative	Japan	Otsuka Pharmaceutical Co., Ltd.	27 May 1983
Pain	United States	Indivior, Inc.	29 Dec 1981

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Back Pain	Phase 3	United States	Braeburn, Inc.	01 Sep 2016
Neuralgia	Phase 3	United States	BioDelivery Sciences International, Inc.	01 Mar 2011
Intervertebral Disc Disease	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Aug 2009
Heroin Dependence	Phase 3	United States	Indivior, Inc.	01 May 2009
opioid dependence methadone	Phase 3	United States	Titan Pharmaceuticals, Inc.	01 Oct 2006
Arthritis Pain	Phase 3	United States	Purdue Pharma LP	01 Jun 2003
Diabetes Mellitus, Type 2	Phase 3	United States	Purdue Pharma LP	01 Apr 2003
Pain Disorder	Phase 3	United States	Purdue Pharma LP	01 Mar 2001
Pain Disorder	Phase 3	United Kingdom	Purdue Pharma LP	01 Mar 2001
Osteoarthritis, Hip	Phase 3	United States	Purdue Pharma LP	01 Jun 1999

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05704543 (CTgov)	Phase 4	Opioid abuse	132	Buprenorphine Extended-Release Injection (Extended-release Buprenorphine: Abdomen)	skyrqheaix(krqjvoufyq) = ruzhkutzcb hcntjkillh (gvsmugmwkh, 41.8) View more	-	25 Mar 2025
				Buprenorphine Extended-Release Injection (Extended-release Buprenorphine: Upper Arm)	skyrqheaix(krqjvoufyq) = irjxbrvyfv hcntjkillh (gvsmugmwkh, 57.4) View more
NCT05283304 (CTN-0110, CTgov)	Phase 2	Methamphetamine abuse \| Methamphetamine dependence	18	Buprenorphine injection (BUP-Inj) (Injectable Buprenorphine (BUP-inj))	civwgrerjs = rwclmjfwly wrtrhhyytg (ytgjyxsdsr, zipldtnvwy - qavdrkkper) View more	-	25 Mar 2025
				Placebo injection (Injectable Placebo (PBO-inj))	civwgrerjs = bomqfdwfgb wrtrhhyytg (ytgjyxsdsr, pzyzmfpzzi - fezqlyhncc) View more
NCT04981678 (CTgov)	Phase 4	Opioid-Related Disorders \| Pain	12	buprenorphine (Buprenorphine Dose Reduction)	dktngmrkuf(cijbnmqlnj) = sxjyingnyc verlfrgefj (abcdbptyfc, 1.5) View more	-	13 Dec 2024
				buprenorphine (Buprenorphine Full Dose Continuation)	dktngmrkuf(cijbnmqlnj) = jylgpecxfn verlfrgefj (abcdbptyfc, 2.4) View more
ASH2024	Not Applicable	Anemia, Sickle Cell	-	Buprenorphine	fgiiywzxuf(irruacjayw) = adiprpxwtw vuvsjsytot (uzuncsnpod ) View more	-	08 Dec 2024
				Full-agonist opioids	fgiiywzxuf(irruacjayw) = dvqkkzwpxh vuvsjsytot (uzuncsnpod ) View more
ASH2024	Not Applicable	-	-	Buprenorphine (Pediatric SCD Providers)	eqkdtejwar(eiuuwaesnk) = hklducdblo djcgpoeipx (twujzbslbn )	-	08 Dec 2024
				Buprenorphine (Adult SCD Providers)	eqkdtejwar(eiuuwaesnk) = ktavawfofg djcgpoeipx (twujzbslbn )
ASH2024	Not Applicable	Anemia, Sickle Cell	-	Buprenorphine (Providers with DEA DATA-2000 waiver)	mfdyzrmsik(wytzltxnki) = nzmfjialwu hmoixbyrku (asjaysnmfx ) View more	-	07 Dec 2024
NCT03852628 (CTgov)	Phase 2	Alcoholism \| Stress Disorders, Post-Traumatic	69	2mg Buprenex+380mg Vivitrol (2mg Buprenex and 380mg Vivitrol)	dmdwydxwqu = ksbmqsoljl vgsmvyanry (qptczdukyq, wifnfkddqj - esrcauzcys) View more	-	07 Jun 2023
				Placebo (SL pill qd, IM injection q4weeks) (Placebo)	dmdwydxwqu = vqnrqzixds vgsmvyanry (qptczdukyq, ajbqlwklwn - kwhrstiswp) View more
NCT03996694 (Pubmed \| Adv Ther)	Phase 1	Hypercarbia \| Respiratory Insufficiency	19	Buprenorphine Buccal Film	jvmghjjigc(uwvexskyqy) = ryukszelli wadpjowkjy (icckecelrw )	-	01 Nov 2020
NCT02537574 (CTgov)	Phase 3	Opioid abuse	380	buprenorphine+naltrexone (NTX/BUP)	dxbktwkvwk = cvyrxbjmrh frsokgvmwn (gcllhihxmj, mpvyvafgoo - eqnlqgpspy) View more	-	09 Jan 2019
				NTX/PBO-B (NTX/PBO-B)	dxbktwkvwk = hxadnctflj frsokgvmwn (gcllhihxmj, xnrrafzwjv - cpyqhggiah) View more
NCT01298765 (CTgov)	Phase 3	Low Back Pain \| Osteoarthritis \| Chronic Pain ... View more	302	Buproneorphine	zngmzrhspb(yimbsytzpp) = zfpxhvblcj qyzkajprzp (aosuotvvww, 1.803) View more	-	07 Aug 2018

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