BACKGROUND Dasotraline is a long-acting dopamine/norepinephrine reuptake inhibitor with a PK profile characterized by slow absorption and a t½ of 47-77 hours, permitting once-daily dosing. In a previous flexible dose study, dasotraline demonstrated significant efficacy in the treatment of binge-eating disorder (BED). The aim of this confirmatory fixed-dose study was to evaluate efficacy and safety of dasotraline in the treatment of patients with BED. METHODS Patients meeting DSM-5 criteria for BED were randomized to 12 weeks of double-blind treatment with dasotraline (4 mg/d or 6 mg/d), or placebo. The primary efficacy endpoint was change in number of binge-eating days per week at week 12. Secondary efficacy endpoints included changes at Week 12 on the Binge Eating Clinical Global Impression of Severity Scale (BE-CGI-S), the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating (Y-BOCS-BE), and the proportion of patients with 100% cessation of binge-eating episodes during the final 4 weeks of treatm funding from Sunovion Pharmaceuticals Inc.BACKGROUND SUSTAIN-2 (NCT02497287) was an open-label, phase III trial evaluating the safety of esketamine (ESK) nasal spray plus a newly initiated oral antidepressant (AD) for up to 1 year in adults with treatment-resistant depression (TRD). ESK is a schedule III drug that acts via glutamate receptor modulation. ESK is rapidly cleared from the plasma, and with intermittent dosing there is no accumulation. Thus, no withdrawal syndrome is expected. The current analysis assessed potential withdrawal symptoms in patients who discontinued ESK after long-term, intermittent use. In the absence of a glutamatergic-specific withdrawal scale, the Physicians Withdrawal Checklist1 (PWC-20) was used. The PWC-20 was designed to assess new or worsening benzodiazepine-like discontinuation symptoms after stopping non-SSRI anxiolytics. METHODS ESK nasal spray was administered two times per week during a 4-week induction phase (IND). https://www.selleckchem.com/products/epz011989.html Responders entered the optimization/maintenance phase (O/M) where ESK nasal spray was dosed eithS Data on 357 patients entering F/U were included in the analysis (91 completed treatment during the IND phase and 141 were treated during O/M). The mean (SD) PWC-20 total scores (range 0-60) at treatment endpoint, Week 1, 2 and 4 were 7.2 (6.8), 7.5(7.0), 7.4 (7.1) and 7.2 (6.9), respectively. At these same assessment times, mean PWC-WS scores (range 0-24) were 0.9 (1.7), 1.0 (1.7), 1.0 (1.8), and 0.9 (1.8). Mean PWC-DS scores (range 0-36) were 6.3 (5.6), 6.5 (5.7), 6.5 (5.8), and 6.3 (5.7), respectively. Complete analysis of data from the entire SUSTAIN-2 dataset will be presented. CONCLUSIONS No indication of drug-specific withdrawal symptoms was seen after stopping up to 1-year of intermittent treatment with ESK nasal spray for TRD. FUNDING ACKNOWLEDGEMENTS Janssen Research and Development.The effectiveness of biofeedback therapy in treating headache has been explored in various clinical settings. However, few studies in the literature focused on well- diagnosed patients who failed properly applied analgesic treatment. The aim of the study is to explore whether the combination of biofeedback and analgesics is more effective than analgesics alone in treating patients with pharmacologically uncontrolled tension type headache and migraine. The hypothesis is that the combination of biofeedback and analgesics is more effective than analgesics alone in treating patients with uncontrolled tension type headache and migraine.Electromyographic and thermal biofeedback was utilized as an add-on treatment for 25 patients whose tension type headache and migraine was pharmacologically uncontrolled. The effect of the combination therapy was compared with the treatment effect of 25 similar patients, who continued receiving pharmacological treatment alone. All the subjects from the two groups were randomly selected from the pool of patients with uncontrolled tension type headache and migraine. The progress of two groups was closely monitored and data was collected for statistical analysis, which consists of Chi Square, non-parametric ANOVA, and Mann- Whitney U test.Some positive results were observed from the group of patients receiving combination therapy of biofeedback and analgesics, including reduced use of analgesics, reduced muscle tension, reduced pain score, decrease in intensity, frequency, and duration of headache. These positive outcomes were rarely observed from the comparison group, in which pharmacological treatment was continued alone.The results indicate that the addition of biofeedback to standard analgesic therapy may be more effective than analgesics alone in treating patients with uncontrolled tension type headache and migraine. Further research is suggested to validate these findings and improve treatment effectiveness.BACKGROUND Deutetrabenazine (Austedo) is approved by the FDA for treatment of tardive dyskinesia (TD) in adults. In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine showed clinically significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores compared with placebo, and there were low rates of overall adverse events (AEs) and discontinuations associated with deutetrabenazine. The objective of this study was to evaluate the long-term safety and tolerability of deutetrabenazine in patients with TD at 3 years. METHODS Patients who completed ARM-TD or AIM-TD were included in this open-label, single-arm extension study, in which all patients restarted/started deutetrabenazine 12 mg/day, titrating up to a maximum total daily dose of 48 mg/day based on dyskinesia control and tolerability. The study comprised a 6-week titration period and a long-term maintenance phase. Safety measures included incidence of AEs, serious AEs (SAEs), and AEs leading to withdrawal, dose reduction, or dose suspensidies and the safety of deutetrabenazine for long-term use in patients with TD.Funding Acknowledgements This study was funded by Teva Pharmaceuticals, Petach Tikva, Israel.BACKGROUND Tourette syndrome (TS) is a neurodevelopmental disorder characterized by the hyperkinetic movements of motor and phonic tics manifested in young age. Currently approved treatments in the United States are antipsychotics haloperidol, pimozide, and aripiprazole, which are associated with serious side effects, including tardive dyskinesia (TD). Deutetrabenazine, a vesicular monoamine transporter type 2 (VMAT2) inhibitor, was approved in 2017 by the US FDA for the treatment of chorea associated with Huntington's disease and TD. Three ongoing studies (Alternatives for Reducing Tics in TS [ARTISTS]) are evaluating the efficacy, safety, and tolerability of deutetrabenazine in reducing tics in TS in children and adolescents (age 6-16 years). METHODS ARTISTS 1, a phase 2/3, response-driven, dose-titration, placebo-controlled study, randomizes patients (N=116) 11 to deutetrabenazine or placebo for 12 weeks. ARTISTS 2, a phase 3, fixed-dose study, randomizes patients (N=150) 111 to deutetrabenazine high or low dose, or placebo for 8 weeks.