Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap - LARVOL DELTA

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

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

Patients' perspectives on buprenorphine subcutaneous implant: a case series. (PubMed, J Med Case Rep) - "These results emphasise the promising impact of OAT via buprenorphine implants in enhancing the well-being and quality of life in the context of OUD."

Journal • Substance Abuse

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Mar 2025 ➔ Sep 2025

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

The experience of buprenorphine implant in patients with opioid use disorder: a series of narrative interviews. (PubMed, Front Psychiatry) - "Conversely, the therapy with buprenorphine implant revealed a significant improvement in the quality of life of the patients, who also largely reported a positive emotional outcome during this therapy, as well as a solid determination to achieve complete recovery. This study illustrates the complex problems of living with OUD and provides insights into the added value of an innovative buprenorphine implant therapy that, due to its administration route and prolonged duration, allows patients to take an additional step toward total opioid abstinence and complete recovery of daily life."

Interview • Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Aug 2024 ➔ Mar 2025 | Trial primary completion date: Aug 2023 ➔ Mar 2024

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

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: Dec 2022 ➔ Aug 2023

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

Buprenorphine and its formulations: a comprehensive review. (PubMed, Health Psychol Res) - "For the purpose of analgesia, three formulations of buprenorphine were developed: IV/IM injectable formulation (Buprenex®), transdermal patch formulation (Butrans®), and buccal film formulation (Belbuca®). Related to opioid dependence, the formulations developed were subcutaneous extended release (Sublocade®), subdermal implant (Probuphine®), and sublingual tablets (Subutex®). Lastly, in order to avoid misuse of buprenorphine for opioid dependence, two combination formulations paired with naloxone were developed: film formulation (Suboxone®) and tablet formulation (Zubsolv®). In this review, we present details of each formulation along with their similarities and differences between each other and clinical considerations."

Journal • Review • Addiction (Opioid and Alcohol) • Pain • Substance Abuse

Sustained anti-pruritic effect in mice with TP-2021, a kappa opioid agonist peptide, delivered by subdermal ProNeura Implants (Neuroscience 2021) - "Pretreatment with TP-2021 or with difelikefalin, (Korsuva™ by Cara Therapeutics, Inc.), was observed to be equally potent in reducing scratching and grooming bouts when injected subcutaneously (0.3 mg/kg in saline) in a 5'-guanidinonaltrindole (5'-GNTI) itch-induced mouse model...The first ProNeura-based product is a six-month buprenorphine implant, with marketing approvals in the US, Canada and Europe...Further refinement of the ProNeura implant formulation is ongoing with the aim of developing a product that could potentially sustain therapeutic anti-pruritic levels of TP-2021 over several months. Disclosures: BBL & CC do not receive ficial support from Titan Pharmaceuticals; TB is a consultant and SS, RP, KD & MR are employees of Titan."

Preclinical • CNS Disorders • Psychiatry

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. (PubMed, World J Psychiatry) - "Oral methadone or sublingual buprenorphine are first-line medications for pharmacotherapy of opioid use disorders (OUDs). Three long-acting buprenorphine depot or implant formulations are currently available for the treatment of OUDs: (1) CAM 2038 (Buvidal) for subcutaneous weekly and monthly application; (2) RBP-6000 (Sublocade™) as a monthly depot formulation; and (3) A six-month buprenorphine implant [Probuphine™]. The pharmacology, clinical efficacy and prospects of these medications are discussed."

Journal • Review • Addiction (Opioid and Alcohol) • Substance Abuse

Reprint of: Biotechnologies and the future of opioid addiction treatments. (PubMed, Int J Drug Policy) - "Using the examples of depot naltrexone and implantable and injectable buprenorphine in the U.S., this essay considers the arc of long-acting opioid treatment and implications for the future. These include the rise of Vivitrol courts and "carceral prescription"-where criminal justice systems mandate medicine to lock up brain receptors much as they might lock up people themselves-as well as use of buprenorphine formulations positioned as increasing both patient benefit and provider control. We also consider lessons from debates on long-acting contraceptive technologies such as Norplant and Depo-Provera. While multiple new long-acting formulations are under development, success will be determined less by characteristics of particular formulations and more by whether or not the new technologies are accompanied by a new ethics of addiction treatment that emphasizes therapeutic alliance, concordance over compliance, and a genuine commitment to allowing patients the..."

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

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

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

Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Medical College of Wisconsin

Clinical • New P2 trial • Head and Neck Cancer • Mucositis • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Biotechnologies and the future of opioid addiction treatments. (PubMed, Int J Drug Policy) - "These include the rise of Vivitrol courts and "carceral prescription"-where criminal justice systems mandate medicine to lock up brain receptors much as they might lock up people themselves-as well as use of buprenorphine formulations positioned as increasing both patient benefit and provider control. We also consider lessons from debates on long-acting contraceptive technologies such as Norplant and Depo-Provera. While multiple new long-acting formulations are under development, success will be determined less by characteristics of particular formulations and more by whether or not the new technologies are accompanied by a new ethics of addiction treatment that emphasizes therapeutic alliance, concordance over compliance, and a genuine commitment to allowing patients the ability to narrate and be believed in their descriptions of their treatment experiences."

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

Novel Long-Acting Buprenorphine Medications for Opioid Dependence: Current Update. (PubMed, Pharmacopsychiatry) - "Opioid maintenance treatment with oral methadone or sublingual buprenorphine is the first-line treatment in opioid dependence. Three novel long-acting buprenorphine formulations have been approved or will be available soon: for subcutaneous weekly and monthly application, the depot formulations CAM 2038 (Buvidal), the monthly depot formulation RBP-6000 (Sublocade™), and a 6-month buprenorphine implant (Probuphine™). Clinical data available so far on the efficacy of these 3 medications are given, and possible clinical implications are discussed."

Journal • Addiction (Opioid and Alcohol)

Measures to Improve Outcomes After an Opioid Overdose (clinicaltrials.gov) - P=N/A; N=200; Recruiting; Sponsor: Nassima Ait-Daoud Tiouririne; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders

Buprenorphine implants: a model for expedited development and approval of new drugs. (PubMed, Curr Med Res Opin) - "Safety and bioavailability profiles of the long-acting products are the same or improved over the parent product. A review of the long-acting drugs provides compelling evidence to recommend that generic drug-controlled release products may be eligible for alternative regulatory programs."

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

Buprenorphine Implants, Injections Are Underused. (PubMed, JAMA) - No abstract available

Journal

Predictors of availability of long-acting medication for opioid use disorder. (PubMed, Drug Alcohol Depend) - "In 2017, XR-NTX was available at most of the minority of facilities offering MOUD, but the buprenorphine implant was not. Increasing the availability of MOUD, including long-acting options, is necessary to address unmet need for opioid use disorder treatment."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Substance Abuse

Prolonged-release buprenorphine formulations: Perspectives for clinical practice (PubMed, Therapie) - "Buprenorphine and methadone are the two main opioids agonist treatments approved for opioid use disorder...Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties..."

Clinical • Journal • Addiction (Opioid and Alcohol) • Pain

Prolonged-release buprenorphine formulations: Perspectives for clinical practice. (PubMed, Therapie) - "Buprenorphine and methadone are the two main opioid agonist treatments approved for opioid use disorder...Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties could..."

Clinical • Journal • Addiction (Opioid and Alcohol) • Pain

Titan Pharmaceuticals Launches Virtual REMS Training For Probuphine Health Care Providers (PRNewswire) - "Titan Pharmaceuticals, Inc....today announced that it has initiated a fully-virtual Probuphine® (buprenorphine) implant Risk Evaluation and Mitigation Strategy ('REMS') training and certification program for qualified health care providers ('HCPs') who treat patients with Opioid Use Disorder ('OUD'). The U.S. Food and Drug Administration ('FDA') has approved the virtual REMS training program for use during the COVID-19 pandemic..."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders

TTNP: New CCO implementing targeted strategy (Zacks) - "Titan will initiate two Phase IV post-marketing studies next year. The first will be a small study costing approximately $3 to $4 million and last for two to three years. A second, observational study is still in development, but is expected to last approximately four years and will cost approximately twice the initial study. Trial design is still in process."

New P4 trial • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry

Probuphine: Regulatory approval in EU for addiction in early 2019 (Titan Pharma) - Q4 & FY 2017 Results

European regulatory • Addiction (Opioid and Alcohol) • CNS Disorders

Titan Pharmaceuticals reports second quarter 2017 financial results (PRNewswire) - "Second quarter license revenue from Probuphine was $77,000, a 93 percent increase over the prior quarter....Titan remains on track to submit an MAA to the EMA in the fourth quarter of 2017."

European regulatory • Addiction (Opioid and Alcohol) • CNS Disorders