Belbuca (buprenorphine BEMA) / Collegium Pharma - LARVOL DELTA

The Intersection of Obesity, Testosterone Therapy, and Atrial Fibrillation: A Case Report (ENDO 2025) - "Clinical case: A 22-year-old male with a history of well-controlled diabetes mellitus (managed with Ozempic) and chronic back pain (treated with Belbuca and hydrocodone-acetaminophen) presented with palpitations and chest pain...In the emergency department, he was found to be in atrial fibrillation with Afib RVR at a heart rate of bpm, refractory to oral diltiazem but controlled with a continuous diltiazem infusion, reducing his heart rate to the 80s...Patient started on 75mg metoprolol for rate control and eliquis for stroke prevention... This case highlights the need for careful management of young patients with a complex medical history involving exogenous testosterone therapy, opioid use, and obesity. Clinicians should be vigilant in monitoring cardiovascular health and considering the risks of erythrocytosis in patients on testosterone therapy. Further research is needed to better understand the mechanisms linking hormonal therapy, erythrocytosis, and arrhythmias."

Case report • Clinical • Atrial Fibrillation • Back Pain • Cardiovascular • Diabetes • Genetic Disorders • Hematological Disorders • Infectious Disease • Metabolic Disorders • Musculoskeletal Pain • Obesity • Pain

Low-dose Buprenorphine as a Modulator of Social Motivation in Schizophrenia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of California, Los Angeles | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Medical College of Wisconsin | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Mucositis • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: AstraZeneca | Phase classification: P2 ➔ P1

Phase classification • Substance Abuse

Collegium to Present Real-World Data at PainConnect 2025, the American Academy of Pain Medicine’s Annual Meeting (GlobeNewswire) - "Collegium Pharmaceutical, Inc....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."

Real-world • Pain

Retrospective Observational Descriptive Study on Use and Rotations to Belbuca®. (PubMed, J Pain Palliat Care Pharmacother) - "The purpose of this study was to better characterize morphine equivalent daily dose (MEDD) equivalencies with buccal buprenorphine, and identify real-world efficacy and safety outcomes associated with the use of buccal buprenorphine for chronic pain at a local VA Medical Center. From the results of this study, a local dosing scheme for Belbuca® based on baseline MEDD was created for facility level guidance. The exact MEDD conversion ratio, however, for individual buprenorphine products as well as MEDD contributed by these products on a patient's overall opioid related risk compared to other full agonist opioids still remains unclear and further studies are warranted."

Journal • Retrospective data • Pain

Case Report: Buprenorphine for Palliation in a Patient with End Stage Renal Disease. (PubMed, J Pain Palliat Care Pharmacother) - "In this case report, we demonstrated buprenorphine buccal film (Belbuca) as a safe and effective opioid treatment option for pain palliation in a dialysis dependent patient. Future studies may be warranted with larger sample size and longer follow up period to study the effect of buprenorphine in the setting of hemodialysis and non-dialysis dependent ESRD population."

Journal • Addiction (Opioid and Alcohol) • Chronic Kidney Disease • Nephrology • Pain • Renal Disease

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov) - P2 | N=15 | Terminated | Sponsor: AstraZeneca | N=100 ➔ 15 | Trial completion date: Dec 2025 ➔ Jul 2024 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Jul 2024; Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Substance Abuse

Low-dose Buprenorphine As a Modulator of Social Motivation in Schizophrenia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: University of California, Los Angeles | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Treatment Characteristics and Dosing Patterns in Chronic Low Back Pain Patients Treated with Belbuca® and Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims Analysis (PAINWeek 2024) - "After Belbuca® initiation, opioid treatment duration shortened (103 vs. 77 days, p=0.012) and the average morphine milligram equivalents (MMEs) improved (42.8 vs. 30.4 MMEs, p=0.048). After applying selection criteria, the sample of 3,368 Medicare patients prescribed Belbuca® or buprenorphine patch was narrowed down to 322 in the non-matched sample. PSM analysis yielded 97 patients in the final matched sample (36 in Belbuca® and 61 in buprenorphine patch).As a result of PSM analysis, patient characteristics were well-balanced across the cohorts. cLBP patients treated with buprenorphine were predominantly women ( > 60%) aged ~71 years."

Medicare • Reimbursement • Retrospective data • US reimbursement • Addiction (Opioid and Alcohol) • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain • Substance Abuse

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 (PAINWeek 2024) - "Non-matched sample consisted of 26,995 patients, with 1,020 patients in CIII buprenorphine cohort (203 in Belbuca® and 817 buprenorphine transdermal patch) and 25,975 patients in CII opioid cohort. After PSM analysis, 1,496 patients were matched in the primary analysis (545 patients in CIII buprenorphine and 951 in CII opioid cohort). Sub-analyses yielded 124 Belbuca® patients matched to 297 CII opioid patients, and 62 Belbuca® patients matched to 62 buprenorphine transdermal patch patients.Compared to CII opioid cohort, CIII buprenorphine treatment was associated with significantly lower rate of confusion (IRR 0.07, p< 0.001), syncope (IRR 0.08, p< 0.001), headache (IRR 0.11, p=0.002), urinary discomfort (IRR 0.16, p< 0.001), constipation (IRR 0.17, p< 0.001), cerebrovascular accident (IRR 0.18, p=0.003), atrial fibrillation (IRR 0.19, p=0.001), osteoarthritis (IRR 0.28, p=0.029), cellulitis (IRR 0.29, p=0.004), pneumonia (IRR 0.34, p=0.001),..."

Medicare • Reimbursement • Retrospective data • US reimbursement • Addiction (Opioid and Alcohol) • Anorexia • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain • Sleep Disorder

Healthcare Costs and Resource Use among Chronic Low Back Pain Patients Treated with Belbuca or Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims Analysis (PAINWeek 2024) - "Out of 3,600 Medicare patients prescribed Belbuca or buprenorphine patch, 379 cases have been identified in a final non-matched sample. After PSM analysis, the final matched sample consisted of 124 patients (44 in Belbuca and 80 in buprenorphine patch).Due to the PSM analysis, there were no between-cohort differences in patient characteristics. The mean age of the study sample was ~72 years, predominantly women (65.9% in Belbuca and 72.5% in buprenorphine patch)."

HEOR • Medicare • Reimbursement • Retrospective data • US reimbursement • Addiction (Opioid and Alcohol) • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain • Psychiatry • Substance Abuse

Exposures Reported to US Poison Centers Involving Buprenorphine Products for Analgesia Compared to Other Opioid Medications (PAINWeek 2024) - "Buprenorphine-containing tablets and sublingual film formulations are approved for use in the treatment of opioid dependence while buprenorphine transdermal patch (Butrans®) and buccal film (Belbuca®) formulations are approved for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate...However, few studies have directly compared real-world abuse rates between Schedule III buprenorphine products for analgesia and Schedule II opioid medications4, and have included buprenorphine buccal film formulation.Purpose/Objectives: Using real-world data captured in the National Poison Data System (NPDS), this study compared reason for exposure, clinical outcomes, and level of healthcare facility utilization between cases involving (1) buprenorphine buccal film, (2) buprenorphine transdermal patch, (3) Schedule II immediate-release opioid formulations..."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Pain • Psychiatry

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®) (PAINWeek 2024) - "Background: Buprenorphine has been approved for analgesia in the US as an intravenous/intramuscular injection (Buprenex®) since 1982, as a transdermal patch (Butrans®) since 2010, and as a buccal film (Belbuca®) since 2015...However, few studies have directly compared real-world abuse rates between buprenorphine products for analgesia and Schedule II opioid medications4, and have included buprenorphine buccal film in those comparisons which is the most recent buprenorphine product approved for analgesia.Purpose/Objectives: The purpose of this study was to compare the rates of nonmedical use (NMU; misuse/abuse) among four product groups: (1) buprenorphine buccal film, (2) buprenorphine transdermal patch, (3) Schedule II immediate-release opioid formulations (CII-IR; solid oral dosage forms of IR formulations containing hydrocodone, oxycodone, hydromorphone, oxymorphone, and tapentadol), and (4) Schedule II extended-release opioid formulations (CII-ER; solid..."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Pain • Psychiatry • Substance Abuse

Collegium Announces Eight Poster Presentations at PAINWeek Conference 2024 (GlobeNewswire) - "Collegium Pharmaceutical, Inc...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."

Clinical data • Back Pain • CNS Disorders • Pain

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2026 ➔ Dec 2025 | Trial primary completion date: May 2026 ➔ Dec 2025

Trial completion date • Trial primary completion date • Substance Abuse

The Use of Buprenorphine in Combination with Full Agonist Opioids for Cancer Pain (IASP 2024) - "TD Bup (Butrans ®) and TM Bup (Belbuca ®) were used. Oxycodone, morphine, hydromorphone, and combination products of hydrocodone/acetaminophen and oxycodone/acetaminophen were used as FAO... Bup, combined with FAOs, appears to be an effective and well-tolerated regimen for treating CP. Additionally, the current recommendation by the FDA to taper the OME of FAO to less than 30 mg per day seems unnecessary. It may be a barrier to Bup introduction in patients with CP."

Combination therapy • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Pain • Palliative care

Collegium Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "Grew Belbuca total prescriptions 2.1% year-over-year and 1.4% quarter-over-quarter in the quarter ended June 30, 2024. Belbuca net revenue was a record $52.2 million, up 21% year-over-year. Xtampza ER net revenue was $44.6 million, up 8% year-over-year. Achieved Xtampza ER gross-to-net of 56.2% in the quarter ended June 30, 2024. Xtampza ER gross-to-net is expected to be in the range of 55% to 57% for the full-year 2024, an improvement from the previous guided range of 56 to 58%."

Sales • Back Pain • CNS Disorders • Pain

Serious treatment-emergent adverse events in chronic low back pain patients treated with buprenorphine or oral opioids: a retrospective commercial claims analysis. (PubMed, J Comp Eff Res) - " Buprenorphine had a better safety profile than oral opioids in cLBP treatment. Belbuca showed a more favorable TEAE profile than buprenorphine transdermal patches and oral opioids."

Adverse events • Journal • Retrospective data • Addiction (Opioid and Alcohol) • Back Pain • Gastroenterology • Hepatology • Lumbar Back Pain • Musculoskeletal Pain • Pain • Psychiatry • Suicidal Ideation

Economic burden and dosing trends of buprenorphine buccal film and transdermal patch in chronic low back pain. (PubMed, Pain Manag) - "Aim: Exploring prescribing trends and economic burden of chronic low back pain (cLBP) patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches...Buccal film also had higher daily doses and wider dosing range. Buprenorphine film is more cost-effective cLBP treatment with more flexible dosing."

HEOR • Journal • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Mucositis • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Collegium Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Collegium Pharmaceutical, Inc...today reported its financial results for the quarter ended March 31, 2024, and provided a corporate update....Grew Belbuca total prescriptions 4.2% in the quarter ended March 31, 2024, compared to the prior year quarter. Belbuca net revenue was a record $50.7 million, up 15% year-over-year. Achieved Xtampza ER gross-to-net of 53.6% in the quarter ended March 31, 2024. Xtampza ER gross-to-net is expected to be in the range of 56% to 58% for the full-year 2024."

Commercial • Back Pain • CNS Disorders • Pain

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Substance Abuse

Collegium Reports Record Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - "Grew Belbuca total prescriptions 3.2% in the quarter ended December 31, 2023, compared to the prior year quarter....Submitted a pediatric extension to the U.S. Food and Drug Administration (FDA) in December 2023 for the Nucynta Franchise to potentially extend exclusivity of the Nucynta Franchise an additional six months to December 27, 2025, for Nucynta ER and January 3, 2027, for Nucynta. The Company expects a decision in the second half of 2024."

Commercial • sNDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain