Multicentre Study with Viloxazine (Vivalan®) in Depressed Patients

Abstract

Viloxazine at doses of 150-300 mg daily for 1 month produced significant and rapid responses (after 3 days) in this multicentre study involving 115 inpatients with moderate to severe depressive illness. Many had proved resistant to previous antidepressive treatment. Side effects were not a major problem of therapy with viloxazine.

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN‐812 (Viloxazine Extended‐Release) Pharmacokinetics in Healthy Adults

“…Sample collection procedures have been previously described. 25 Briefly, blood samples for viloxazine PK were collected in period 1 (days 1-4) and period 3 (days 14-17) and were collected relative to SPN-812 administration at predose (baseline, time 0) and 0.5, 1, 2, 3, 4, 5,6,8,10,12,16,20,24,30,36,48,60, and 72 hours postdose. The actual time and date of each blood sample collection was recorded.…”

Viloxazine in the Management of CNS Disorders: A Historical Overview and Current Status

“…In numerous double-blind and open-label studies, viloxazine was effective in treating various types of depressive disorders (some of which are not included in the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition [ 45 ]), including endogenous, neurotic, psychotic, and reactive depression, chronic and severe depression, and depression with comorbid conditions (reviewed in [ 2 ] and [ 46 ]). Across several studies in cohorts with depression, viloxazine reduced not only depressive symptoms but concomitant symptoms of anxiety ([ 7 , 47 , 48 ], also reviewed in [ 2 ]) and alcohol abuse in patients with comorbid alcohol dependence [ 49 ]. In a multicenter trial of 115 patients with moderate-to-severe depression, viloxazine was also effective in patients whose depression had not responded to prior antidepressant treatment [ 7 ].…”

“…Across several studies in cohorts with depression, viloxazine reduced not only depressive symptoms but concomitant symptoms of anxiety ([ 7 , 47 , 48 ], also reviewed in [ 2 ]) and alcohol abuse in patients with comorbid alcohol dependence [ 49 ]. In a multicenter trial of 115 patients with moderate-to-severe depression, viloxazine was also effective in patients whose depression had not responded to prior antidepressant treatment [ 7 ]. Compared with other available antidepressants at the time (e.g., imipramine, amitriptyline), viloxazine was considered to be as effective in reducing symptoms of depression, but with better tolerability [ 2 , 46 , 47 ].…”

“…Viloxazine IR was generally well tolerated in clinical studies, with the most frequent side effects including gastrointestinal disturbances such as nausea and vomiting, as well as headache, dry mouth, and fatigue [ 2 , 46 – 48 , 50 ]. In a multicenter study of 115 adults with moderate-to-severe depression administered 150–300 mg of viloxazine, nausea and fatigue occurred in 13.2% and 9.4% of patients, respectively, with a relatively low incidence of headache (4.7%), vomiting (3.8%), and dry mouth (1.9%) [ 7 ]. In two separate studies of patients with mild-to-moderate depression, 150–200 mg/day of viloxazine was found to be efficacious in reducing symptoms of depression and anxiety, with mild side effects that were primarily gastrointestinal in nature [ 47 , 48 ].…”

“…Subsequently, an IR formulation was developed and approved for the treatment of adults with depression in the UK in 1974, and marketed there and in several European countries for over 30 years. While commercially available, viloxazine was used in both adult and elderly patients as a two-times or three-times daily treatment [ 2 ], and was distributed under the trade names Viloxazin [ 3 ], Emovit [ 4 ], Viloxazina [ 5 ], Viloxazinum [ 5 ], Vivarint [ 6 ], Vicilan [ 2 ], and Vivalan [ 7 ].

Fig.

…”