Reboxetine
(R,R)-(–)-reboxetine (top),
(S,S)-(+)-reboxetine (bottom) |
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| Clinical data | |
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| Trade names | Edronax, others |
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| Routes of administration |
Oral (tablets) |
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| Pharmacokinetic data | |
| Bioavailability | ≥94% |
| Protein binding | 97–98% |
| Metabolism | Liver (CYP3A4-mediated) |
| Biological half-life | 12–12.5 hours |
| Excretion | Urine (78%; 9–10% unchanged) |
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| Chemical and physical data | |
| Formula | C19H23NO3 |
| Molar mass | 313.391 g/mol |
| 3D model (Jmol) | |
| Chirality | Racemate |
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Reboxetine (brand names: Edronax (AU, IE, IL, NZ, ZA, UK), Prolift (AR,†BR, CL, VE†)) is a drug of the norepinephrine reuptake inhibitor class, marketed as an antidepressant by Pfizer for use in the treatment of unipolar depression, although it has also been used off-label for panic disorder and ADHD. It is approved for use in many countries worldwide, but has not been approved for use in the United States. Although its efficacy as an antidepressant has been challenged in multiple published reports, its popularity has continued to increase.
There has been much debate as to whether reboxetine is more efficacious than placebo into the treatment of depression. According to a 2009 meta-analysis of 12 second-generation antidepressants, reboxetine was no more effective than placebo, and was "significantly less" effective, and less acceptable, than the other drugs in treating the acute-phase of adults with unipolar major depression.
The British MHRA said in September 2011 that the study had several limitations, and that "Overall the balance of benefits and risks for reboxetine remains positive in its authorised indication." A UK and Europe-wide review of available efficacy and safety data has confirmed that reboxetine has benefit over placebo in its authorised indication. Efficacy was clearly shown in patients with severe or very severe depression.
According to a systematic review and meta-analysis by IQWiG, including unpublished data, published data on reboxetine overestimated the benefit of reboxetine versus placebo by up to 115% and reboxetine versus SSRIs by up to 23%, and also underestimated harm, concluding that reboxetine was an ineffective and potentially harmful antidepressant. The study also showed that nearly three quarters of the data on patients who took part in trials of reboxetine were not published by Pfizer until now.
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Wikipedia