risperidone controlled-release implant (BB-0817) / Braeburn - LARVOL DELTA

Is Timing Everything? Exposure to Parental Depression and Mental Health in Adulthood (AACAP 2025) - "Distributed lag models were utilized to identify cumulative and timing effects of exposure to parental depression across childhood. Between 3342 and 3795 participants (2086-2506 [62.4%-66.0%] female) were included... Both timing and chronicity of parental depression influenced offspring adult mental health. The strong association between maternal prenatal depression and offspring psychotic symptoms supports the fetal origins of mental health hypothesis. Early interventions that reduce cumulative exposure to parental depression may help prevent the intergenerational transmission of mental illness.DEV, EPI, DDD"

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry

Antioxidant-mediated control of degradation and drug release from surface-eroding poly(ethylene carbonate). (PubMed, Acta Biomater) - "When polymer films loaded with distinct antioxidants (vitamins) along with the model drugs leuprorelin and risperidone were incubated in superoxide radical solution and phagocyte culture, the mass loss and drug release from the delivery vehicle was a function of the type and dose of the utilized antioxidant...Furthermore, linear correlations were obtained between the mass loss of the polymer films and the released fraction of drug (with slopes close to 1), a clear indication for the surface erosion of poly(ethylene carbonate) in vitro and in vivo. Overall, an addition of antioxidants to poly(ethylene carbonate)-based controlled drug delivery vehicles represents a reasonable approach to modify the performance of long-acting medications, especially when a "life time" of weeks to months needs to be achieved."

Journal

Newer Formulations of Risperidone: Role in the Management of Psychotic Disorders. (PubMed, CNS Drugs) - "Risperidone ISM is a monthly intramuscular injection that does not require loading doses or concurrent oral risperidone. RBP-7000 is a monthly subcutaneous injection not requiring loading or oral supplementation. BB0817 is a 6-monthly implant of risperidone injected subcutaneously. All three preparations have been shown to be effective and well tolerated in clinical trials. A fourth formulation (TV-46000), which can be given subcutaneously every 1 or 2 months, has recently begun trials."

Journal • Review • CNS Disorders

Electron beam sterilization of implantable rods with risperidone and with 17-β-estradiol: a structural, thermal and morphology study. (PubMed, Acta Bioeng Biomech) - "Electron beam irradiation of rods with risperidone and rods with 17-β-estradiol is an adequate method for sterilizing implantable drug delivery systems."

Journal

Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant (clinicaltrials.gov) - P2; N=66; Completed; Sponsor: Braeburn Pharmaceuticals; Terminated ➔ Completed

Clinical • Trial completion

Safety and Tolerability of Risperidone Implants (clinicaltrials.gov) - P3; N=140; Completed; Sponsor: Braeburn Pharmaceuticals; Terminated ➔ Completed

Clinical • Trial completion

Improvement of lower extremity Holmes tremor with intrathecal baclofen: First Report (MDS Congress 2019) - "The tremor did not respond to sequential trials of pramipexole, levodopa, propranolol, topiramate, risperidone, and clonazepam...Through its action on spinal GABA-B receptors, ITB may suppress lower extremity cerebellar tremor in a manner similar to its effect on post-stroke spasticity. Weiss N et al described incidental improvement of upper extremity cerebellar intentional tremor after baclofen pump was implanted for spasticity [6].Our case is the first to demonstrate responsiveness of atypical Holmes tremor to ITB. ITB pump may be a promising neuromodulation option for medically-refractory atypical Holmes tremor of the lower extremity."

SLEEP ASSESSMENT IN OBSESSIVE-COMPULSIVE DISORDER TREATED WITH DEEP BRAIN STIMULATION – DOUBLE CASE REPORT OF MORNING AND EVENING CHRONOTYPE PATIENTS (WSS 2019) - "Materials and Two 28-year-old Caucasian male patients with severe treatment-resistant OCD underwent bilateral implantation of electrodes into nucleus accumbens (NAc) and ventral part of the anterior limb of internal capsule (vALIC) and Medtronic Activa SC single-channel non-rechargeable stimulators...Pharmacotherapy was continued from pre-operative period: Case A - valproates, fluoxetine and trazodone (periodically), Case B - sertraline, clomipramine, risperidone and lamotrygine... DBS along with pharmacotherapy and CBT significantly increased SQ and DS in an evening chronotype case. Improvement in OCD symptoms and functioning could have contributed to better sleep hygiene. In morning chronotype case baseline SQ and DS were better than case A, still the combined treatment contributed to improvement, although the patient significantly reduced sleep time."

Clinical

Neurobehavioral effects of chronic low-dose risperidone administration in juvenile male rats. (PubMed, Behav Brain Res) - "Continued research is needed to determine whether early exposure to risperidone may lead to differences in working memory at longer time-points. These results seem to indicate that early low dose risperidone treatment during the peri-adolescent and adolescent period does not severely impair behavior."

Journal • Preclinical

Treating an Adolescent with Long QT Syndrome for Bipolar Disorder: A Case Presentation. (PubMed, Psychopharmacol Bull) - "LQTS is a serious health issue for children and adolescents diagnosed with BD. This condition should be kept in mind especially in cases where familial risk factors are present and precautions need to be maintained upon required assessments. These cases need to be closely monitored due to risk factors related to both BD and LQTS, in a multidisciplinary fashion, involving both psychiatry and cardiology divisions."

Journal