Sunovion

About: Sunovion is a company organization based out in London, United Kingdom. It is known for research contribution in the topics: Lurasidone & Placebo. The organization has 572 authors who have published 1022 publications receiving 18488 citations. The organization is also known as: Sunovion Pharmaceuticals, Inc..

Phase transfer catalysis

Abstract: Novel method for conducting phase transfer catalysis in a multiphase reaction system wherein the different phases are separated by a membrane permeable to the phase transfer catalyst and its various reaction complexes. The invention also relates to membranes and a membrane-containing apparatus useful in carrying out phase transfer catalysis.

Automatic Supported Liquid Extraction (SLE) Coupled with HILIC-MS/MS: An Application to Method Development and Validation of Erlotinib in Human Plasma

Abstract: A novel bioanalytical method was developed and validated for the quantitative determination of erlotinib in human plasma by using the supported liquid extraction (SLE) sample cleanup coupled with hydrophilic interaction liquid chromatography and tandem mass spectrometric detection (HILIC-MS/MS). The SLE extract could be directly injected into the HILIC-MS/MS system for analysis without the solvent evaporation and reconstitution steps. Therefore, the method is simple and rapid. In the present method, erlotinib-d6 was used as the internal standard. The SLE extraction recovery was 101.3%. The validated linear curve range was 2 to 2,000 ng/mL based on a sample volume of 0.100-mL, with a linear correlation coefficient of > 0.999. The validation results demonstrated that the present method gave a satisfactory precision and accuracy: intra-day CV < 5.9% (<8.4% for the lower limit of quantitation, LLOQ) with n = 6 and the accuracy of 98.0–106.0%; inter-day CV < 3.2% (<1.5% for LLOQ) with n = 18 and the accuracy of 100.0–103.2%. A dilution factor of 10 with blank plasma was validated for partial volume analysis. The stability tests indicated that the erlotinib in human plasma is stable for three freeze-thaw cycles (100.0–104.5% of the nominal values), or 24-h ambient storage (100.0–104.8% of the nominal values), or 227-day frozen storage at both -20 °C (91.5–94.5% of the nominal values) and -70 °C (93.3–93.8% of the nominal values). The results also showed no significant matrix effect (<6.3%) even with direct injection of organic extract into the LC-MS/MS system. The validated method has been successfully applied to support a clinical study.

Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) Therapy Adherence for Patients with Type 2 Diabetes in a Medicare Population.

Abstract: Anti-diabetes medication regimen adherence is a clinical challenge in elderly patients with type 2 diabetes (T2D) and other comorbidities associated with aging. Glucagon-like peptide-1 receptor agonists (GLP-1RA) therapies such as exenatide once weekly (QW), exenatide twice daily (BID), and liraglutide once daily (QD) are an increasingly used class of drugs with proven efficacy and tolerability. Real-world evidence on adherence to GLP-1RAs in elderly or disabled patients is limited. To further the understanding of this drug class, the current study examined medication adherence in Medicare patients aged ≥65 years with T2D initiating a GLP-1RA. This retrospective cohort study used medical and pharmacy claims between 2010 and 2013 for Medicare members in a United States health plan diagnosed with T2D who were new initiators of either exenatide QW (n = 537), exenatide BID (n = 923), or liraglutide QD (n = 3,673). Included patients were between the ages of 65 and 89 and were continuously enrolled for 6 months pre- and post-index. Medication adherence was examined during the post-index period using proportion of days covered (PDC) ≥80% and ≥90%. A significantly higher percentage of patients receiving exenatide QW had a PDC ≥80% (43.2%) versus exenatide BID (39.0%, P < 0.01) and liraglutide QD (35.0%, P < 0.001). The patients receiving exenatide QW were significantly more likely to reach a PDC of ≥90% (37.2%, P < 0.001) than those initiating exenatide BID (20.6%) or liraglutide QD (23.3%). While results from this retrospective study suggest room for improvement in adherence to GLP-1RAs, medication adherence rates for patients initiating therapy with exenatide QW were higher than patients initiating therapy with exenatide BID or liraglutide QD. Further research is needed to validate these findings in other T2D patient populations. Funding: AstraZeneca Pharmaceuticals.

Efficacy and Safety of Lurasidone in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study

Abstract: Objective: To evaluate the efficacy and safety of lurasidone in acutely symptomatic adolescent patients with schizophrenia. Methods: Patients aged 13–17 years were randomly assigned to 6 weeks of double-blind, fixed-dose lurasidone (40 or 80 mg/day) or placebo. Primary and key secondary efficacy measures were change from baseline to week 6 in the Positive and Negative Symptom Scale (PANSS) total score and Clinical Global Impressions-Severity (CGI-S) score, respectively, using mixed model for repeated measurement (MMRM) analysis. The proportion of patients achieving treatment response at endpoint, based on ≥20% reduction in PANSS total score, was analyzed using a logistic regression model. Results: Least-squares (LS) mean change in PANSS total score from baseline to week 6 was −18.6 with lurasidone 40 mg/day (N = 108; p < 0.001 vs. placebo; effect size = 0.51), −18.3 with lurasidone 80 mg/day (N = 106; p < 0.001 vs. placebo; effect size = 0.48), and −10.5 with placebo (N = 112). Similarly, LS mean...