Reboxetin (Edronax, Vestra) has little benefit in depression treatment : IQWiG

Reboxetin has no significant benefit in controlling depression, according to the final report of the Institute for Quality and Efficiency in Health Care (IQWiG).

There is no scientific proof that people suffering from depression can benefit from taking reboxetine.

The final evaluation of reboxetine, however, is only possible after manufacturers disclosed data that had previously been concealed.

Reboxetin is sold under tradenames Edronax, Norebox, Prolift, Solvex, Davedax and Vestra.

Reboxetine was approved in Germany in December 1997. Pfizer also applied for approval in the USA but this was evidently not granted in 2001. By early 2007, reboxetine was licensed worldwide in over 60 countries.

Reboxetine (Edronax) is a relatively well-tolerated, relatively selective noradrenergic agent. Crudely, whereas serotonin plays a vital role in anxiety and mood, noradrenaline is essential to maintaining drive, self-assertiveness and the capacity for reward. There’s a fair bit of evidence that chronically depressive people have dysfunctional and atypical noradrenergic systems – particularly their alpha 2- and beta-adrenoceptors.

It was evident that the manufacturer, Pfizer, was concealing almost two thirds of all data collected in trials to date, IQWiG said.

However, after the preliminary report was published, Pfizer and Essex Pharma decided to make the unpublished data and information on trials accessible. Only then was it possible to assess all three drugs based on complete data.

The summary of results from published and non-published trials does not provide proof of benefit of reboxetine, whereas the data from the published trials appear to suggest a benefit.

IQWiG had analysed a total of 17 trials on reboxetine when preparing the final report. Its analysis shows that there is no proof of benefit either for acute therapy or for relapse prevention. The patients did not respond any better to the therapy than to a placebo, nor was there an improvement in their social functioning level.

There were only two specific situations where indications of a benefit could be found. A very small trial with a total of 52 patients treated in hospital provided an indication that those receiving reboxetine responded better to the treatment than those receiving placebo.

Nevertheless, it could not be shown in this trial that symptoms typical of depression completely disappeared. Another trial with outpatients also gives indications, although only for relapse prevention. In short-term acute therapy reboxetine does not alleviate symptoms of depression as well as drugs in the SSRI drug class.

Also, patients discontinued treatment more frequently due to adverse side effects, both when compared to placebo and in the comparison with fluoxetine, another antidepressant from the selective serotonin reuptake inhibitor class (SSRI).

“Deception through concealment of trial data is no trivial offence”, stated IQWiG’s director, Peter Sawicki.

The study sponsors are depriving patients and doctors of the opportunity to make an informed decision on different therapy options. As the example of reboxetine shows, concealing trial data can lead to patients receiving a drug, for which there is not only no proof of benefit, but which can also cause harm, he noted.