Publications by authors named "B Levinson"
Background: A novel buprenorphine (BUP) extended-release formulation (BUP-XR) produced as a lipid-encapsulated, low viscosity BUP suspension for subcutaneous (SC) injection to control pain was evaluated for pharmacokinetics and safety in four adult male cynomolgus monkeys.
Methods: Each animal was given 0.2 mg/kg reformulated BUP-XR SC.
Article Synopsis
- * A total of 46 patients were enrolled, with a median age of 60, and the results showed low incidences of grades 2-4 (17.4%) and 3-4 (4.4%) acute GVHD by day +120.
- * The CAST regimen was found to be safe and effective in reducing acute GVHD, with favorable outcomes in terms of chronic GVHD rates and overall survival, according to
Checkpoint immunotherapies (CPIs) have improved outcomes for metastatic melanoma patients, with objective response rates to combination ipilimumab and nivolumab of ~58%. Preclinical data suggest that histone deacetylase (HDAC) inhibition enhances antitumor immune activity and may augment CPI. In a phase Ib open-label pilot trial (NCT03565406), patients with therapy-naive metastatic melanoma were treated with the class I/IV HDAC inhibitor mocetinostat orally three times a week in combination with nivolumab and ipilimumab every 3 weeks for 12 weeks followed by 12-week maintenance cycles of nivolumab every 2 weeks and mocetinostat at the same dose and schedule as induction.
View Article and Find Full Text PDFA novel buprenorphine (BUP) extended-release formulation (BUP-XR) produced as a lipid-encapsulated, low viscosity BUP suspension for SC injection to control pain was evaluated for pharmacokinetics and safety in Sprague-Dawley rats given either 0.65 mg/kg (low dose) or 1.30 mg/kg (high dose).
View Article and Find Full Text PDFLong-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years.
J Am Acad Child Adolesc Psychiatry
January 2022
Objective: To investigate long-term (12-month) safety and symptom control of extended-release methylphenidate (MPH-MLR) in children aged 4 to <6 years after treatment optimization.
Method: A total of 90 children aged 4 to <6 years with attention-deficit/hyperactivity disorder (ADHD) were enrolled from 2 MPH-MLR studies. Treatment-emergent adverse events (TEAEs) and ADHD symptom control were assessed in the safety population (n = 89) and modeled with mixed model analyses.