EFFEXOR XR Rx

Generalized Anxiety Disorder (GAD)

Study 1 and 2

• The efficacy of Effexor XR was based on two 8-week, placebo-controlled, fixed-dose studies (75 to 225 mg per day) in adult outpatients meeting DSM-IV criteria for GAD.

• Study 1 showed that treatment with Effexor XR achieved superiority over placebo for the 75, 150, and 225 mg per day doses, as measured by the HAM-A total score, both the HAM-A anxiety and tension items, and the CGI scale. The 75 and 150 mg doses were not as consistently effective as the highest dose.

• Study 2 showed that treatment with Effexor XR 75 and 150 mg per day were more effective compared to placebo. The 75 mg/day dose was more consistently effective vs the 150 mg/day dose.

Study 3 and 4

• Two 6-month studies evaluated Effexor XR doses of 37.5, 75, and 150 mg per day (Study 3) and the other evaluated Effexor XR doses of 75 to 225 mg per day (Study 4). 

• Treatment with daily doses of Effexor XR 75 mg or higher were more effective vs placebo on the HAM-A total, both the HAM-A anxiety and tension items, and the CGI scale during 6 months of treatment.

Social Anxiety Disorder (also known as Social Phobia)

• The efficacy of Effexor XR was evaluated in 4 double-blind, parallel-group, 12-week, multicenter, placebo-controlled, flexible-dose studies (studies 1–4) and one  double-blind, parallel-group, 6-month, placebo-controlled, fixed/flexible-dose study, which included doses in a range of 75 to 225 mg per day in adult outpatients meeting DSM-IV criteria for SAD (study 5).

• In all 5 studies, treatment with Effexor XR was statistically significantly more effective vs placebo on the Liebowitz Social Anxiety Scale (LSAS) total score. 

• There was no evidence for any greater effectiveness of the 150 to 225 mg per day group vs 75 mg per day group in the 6-month study.

Panic Disorder (PD)

Study 1 and 2

• The efficacy of Effexor XR was evaluated in 2 double-blind, 12-week, multicenter, placebo-controlled studies (study 1 and 2) in adult outpatients meeting DSM-IV criteria for PD with or without agoraphobia. Patients received fixed doses of 75 or 150 mg per day in Study 1, and 75 or 225 mg per day in Study 2.

• Both studies showed that treatment with Effexor XR was statistically significantly more effective for each fixed dose vs placebo on PAAS, PDSS total score, and CGI Improvement scale.

Study 3

• The efficacy of Effexor XR was evaluated in a longer-term study (Study 3) in adult outpatients meeting DSM-IV criteria for PD who responded during a 12-week open phase with Effexor XR (75 to 225 mg per day). Patients were randomly assigned to continue the same Effexor XR dose (75, 150, or 225 mg) or switch to placebo for observation for relapse under double-blind conditions.

• Response during the open phase was defined as ≤ 1 full-symptom panic attack per week during the last 2 weeks of the open phase and a CGI Improvement score of 1 (very much improved) or 2 (much improved).

• Relapse during the double-blind phase was defined as having 2 or more full-symptom panic attacks per week for 2 consecutive weeks or having discontinued due to loss of effectiveness as determined by the investigators during the study.

• Treatment with Effexor XR achieved a statistically significantly longer time to relapse vs placebo.

Major Depressive Disorder (MDD)

Study 1 and 2

• The efficacy of Effexor XR was based on 2 placebo-controlled, short-term (8 weeks for study 1; 12 weeks for study 2), flexible-dose studies, with doses starting at 75 mg per day and ranging to 225 mg per day in adult outpatients diagnosed with MDD. 

• Moderately depressed patients were initiated with venlafaxine 75 mg/day.

• Both studies showed that treatment with Effexor XR achieved superiority over placebo on the primary efficacy outcome, defined as change from baseline in the HAM-D-21 total score to the endpoint visit, and on the key secondary efficacy outcome, the Clinical Global Impressions (CGI) Severity of Illness scale.

Study 3

• The efficacy of Effexor XR was based on a 4-week study of inpatients diagnosed with MDD with melancholia, with doses of Effexor in a range of 150 to 375 mg/day (divided 3 times daily).

• Treatment with Effexor achieved superiority over placebo based on the HAM-D-21 total score.

Study 4

• In the longer-term 26-week Study 4, adult outpatients with MDD who responded to an 8-week open-label study on Effexor XR (75, 150, or 225 mg once daily) were randomly assigned to continuation of their same Effexor XR dose or placebo.

• Response during the open-label phase was defined as CGI Severity of Illness item score of at least 3 and a HAM-D-21 total score of less than or equal to 10 at the day 56 evaluation.

• Relapse during the double-blind phase was defined as: (1) a reappearance of MDD as defined by DSM-IV criteria and a CGI Severity of Illness item score of at least 4 (moderately ill), (2) two consecutive CGI Severity of Illness item scores of at least 4, or (3) a final CGI Severity of Illness item score of ≥4 for any patient who withdrew from the study for any reason. 

• Treatment with Effexor XR achieved statistically significantly lower relapse rates over 26 weeks vs placebo.

Study 5

• In the second longer-term 52-week Study 5, adult outpatients with MDD, recurrent type, who had responded (HAM-D-21 total score ≤12 at the day 56 evaluation) and continued to be improved were randomly assigned to continue the same Effexor dose or to placebo.

• Treatment with Effexor XR achieved statistically significantly lower relapse rates over 56 weeks vs placebo.