- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Journal, Interview: The experience of buprenorphine implant in patients with opioid use disorder: a series of narrative interviews. (Pubmed Central) - Sep 18, 2023
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.
- |||||||||| Trial completion date, Trial primary completion date: Transdermal Buprenorphine for the Treatment of Radiation-Induced Mucositis Pain in Head and Neck Cancer Patients (clinicaltrials.gov) - Sep 7, 2023
P2, N=20, Recruiting,
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. Trial completion date: Aug 2024 --> Mar 2025 | Trial primary completion date: Aug 2023 --> Mar 2024
- |||||||||| Vulnofast gel (RLP-068) / Molteni Therap
Photodynamic therapy with Zn(II) phthalocyanine (RLP068/Cl) for hidradenitis suppurativa (Room 2) - Feb 2, 2023 - Abstract #EHSF2023EHSF_128;
Finally, PDT seems not to induce antimicrobial resistance. PDT with RLP068/Cl represent an interesting therapeutic option in the landscape of the future treatment of HS as monotherapy for mild HS or in association with biologics for moderate-severe HS.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Review, Journal: Buprenorphine and its formulations: a comprehensive review. (Pubmed Central) - Aug 25, 2022
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.
- |||||||||| Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, Vifor
Sustained anti-pruritic effect in mice with TP-2021, a kappa opioid agonist peptide, delivered by subdermal ProNeura Implants (Virtual Only) - Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_4691;
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.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Review, Journal, Benefit-risk assessment: Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management. (Pubmed Central) - Nov 29, 2021
The benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting.
- |||||||||| Vulnofast gel (RLP-068) / Molteni Therap
Clinical, Journal: Photodynamic Therapy With RLP068 and 630-nm Red LED Light in Foot Ulcers in Patients With Diabetes: A Case Series. (Pubmed Central) - Oct 26, 2021
In all cases, examined photodynamic therapy with photosensitizer RLP068 and red light at 630 nm was found to reduce lesion area and inflammation and to ensure the decrease of bacterial load, hence reducing treatment times and antibiotics use, improving patient outcomes, and reducing the incidence of amputations. The simultaneous combination of photodynamic therapy with other ancillary physical-based treatments such as therapeutic magnetic resonance or Bio-Electro-Magnetic-Energy-Regulation was observed to be safe, time-saving, and able to lead to faster healing.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Review, Journal: Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. (Pubmed Central) - Oct 12, 2021
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.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Journal: Novel Long-Acting Buprenorphine Medications for Opioid Dependence: Current Update. (Pubmed Central) - Sep 23, 2021
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.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Clinical, Journal: Prolonged-release buprenorphine formulations: Perspectives for clinical practice. (Pubmed Central) - Sep 19, 2021
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 be particularly appreciated in stabilized patients bothered with the daily intake of the treatments, or specific situations at risk of treatment dropout (e.g., following hospital discharge or prison release).
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Journal: Reprint of: Biotechnologies and the future of opioid addiction treatments. (Pubmed Central) - Aug 17, 2021
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.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Journal: Biotechnologies and the future of opioid addiction treatments. (Pubmed Central) - Aug 7, 2021
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.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Journal: Buprenorphine implants: a model for expedited development and approval of new drugs. (Pubmed Central) - Jul 17, 2021
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.
- |||||||||| Vulnofast gel (RLP-068) / Molteni Therap
Clinical, Journal, HEOR: New Perspective to Improve Care of Patients with Infected Diabetic Foot Ulcer: Early Economic Impact of the Use of Photodynamic Therapy with RLP068 (Based) System. (Pubmed Central) - Mar 6, 2021
Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process. The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system.
- |||||||||| Vulnofast gel (RLP-068) / Molteni Therap
Clinical, Journal: Antimicrobial Photodynamic Therapy in Infected Diabetic Foot Ulcers: A Multicenter Preliminary Experience. (Pubmed Central) - Dec 17, 2020
Similar effects of the first treatment were observed in sample B. In both samples, the ulcer area showed a significant reduction during follow-up, even in patients with ulcers infected with gram-negative germs or with exposed bone. RLP068 seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap, Belbuca (buprenorphine BEMA) / Collegium Pharma
Enrollment open: Measures to Improve Outcomes After an Opioid Overdose (clinicaltrials.gov) - Oct 28, 2020
P=N/A, N=200, Recruiting,
RLP068 seems to be a promising topical wound management procedure for the treatment of infected diabetic foot ulcers. Not yet recruiting --> Recruiting
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap, Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
Journal: Predictors of availability of long-acting medication for opioid use disorder. (Pubmed Central) - Jul 16, 2020
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.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Clinical, Journal: Prolonged-release buprenorphine formulations: Perspectives for clinical practice (Pubmed Central) - Jun 6, 2020
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 be particularly appreciated in stabilized patients bothered with the daily intake of the treatments, or specific situations at risk of treatment dropout (e.g., following hospital discharge or prison release).
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Clinical, Journal: Buprenorphine Implant Removal 7 Years Postinsertion: A Case Report. (Pubmed Central) - Mar 14, 2020
All implants were able to be removed using the standard explant technique of midline incision and limited tissue dissection. While extending length of treatment beyond the indicated 6-month period is not being espoused, this case demonstrates that although situations may arise where implants may remain in an individual for longer than the intended dosing period, implants may be removed safely despite remaining implanted for longer than intended.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Journal: Pharmacology Update: Probuphine: The Long-Acting Buprenorphine Implant. (Pubmed Central) - Jan 8, 2020
This article reports previously published evidence and presents four unpublished clinical cases of DFUs treated in the real-life setting with PDT. No abstract available
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Multidisciplinary support for buprenorphine-naloxone treatment of opioid use disorder (Carmel Mission Inn – Carmelo Ballroom) - Jan 4, 2020 - Abstract #WSMRF2020WSMRF_174;
It highlights importance of an interdisciplinary treatment plan for patients undergoing treatment for OUD. It identifies an option of buprenorphine implantation as an attainable advancement in OUD treatment given the present infrastructure in Wenatchee.
- |||||||||| RLP-068 / Molteni Therap
Journal: Photodynamic therapy in infected venous and mixed leg ulcers: a pilot experience. (Pubmed Central) - Oct 2, 2019
To assess the tolerability and efficacy of photodynamic therapy (PDT) with RLP068, a novel phthalocyanine-derived photosensitiser, in controlling the bacterial load in different leg ulcers, due to vascular pathophysiology...The treatment was generally well tolerated. Studies with a greater number of patients and a control group are planned to confirm these results.
- |||||||||| Sublocade (buprenorphine once-monthly depot) / Indivior
Review, Journal: New slow-release buprenorphine formulations for optimization of opioid substitution (Pubmed Central) - Sep 27, 2019
In addition to the novel weekly and monthly subcutaneously injectable buprenorphine depot CAM 2038 (Buvidal®), which is already available in Germany, two other long-acting buprenorphine formulations may be introduced in the near future: the monthly depot formulation RBP-6000 (Sublocade™) and a 6-month buprenorphine depot implant (Probuphine™). Basic pharmacological and clinical data of these three medications are given and possible clinical applications are discussed.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Journal: Buprenorphine treatment for opioid use disorder: recent progress. (Pubmed Central) - Aug 21, 2019
There is a need for more comparative studies between longer-acting BUP formulations and currently available SL BUP. Future studies should also include other clinically meaningful outcomes such as quality of life measures, long-term remission rates and cost-effectiveness.
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Enrollment change: Re-Treatment Study of Probuphine in Opioid Addiction (clinicaltrials.gov) - Oct 23, 2012
P3, N=85, Completed,
Not yet recruiting --> Enrolling by invitation N=120 --> 85
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Trial termination: PRO-809: Study of Probuphine in Patients With Opioid Dependence (clinicaltrials.gov) - Oct 22, 2012
P3, N=16, Terminated,
Active, not recruiting --> Completed Suspended --> Terminated; This study was terminated for reasons not related to efficacy or safety
- |||||||||| Sixmo (buprenorphine implant) / Knight Therap, Titan, Molteni Therap
Enrollment change: PRO-809: Study of Probuphine in Patients With Opioid Dependence (clinicaltrials.gov) - Oct 22, 2012
P3, N=16, Terminated,
Suspended --> Terminated; This study was terminated for reasons not related to efficacy or safety N=200 --> 16
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