Antidepressants in Japan

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The number of new

antidepressants on the market in Japan, is significantly less than Western countries.[1]

One of the biggest barriers to antidepressants coming to the market is that the

medical insurance system in Japan is national, and the authorities are keen to contain a potentially explosive market for drugs like antidepressants that, from the Japanese perspective, could be used or abused by persons in various forms of distress.[2]

Although large epidemiological studies have not been done in Japan, it is thought that up to 6 million Japanese suffer from depression, with a lifetime prevalence of 13 to 17.3%, which is similar to that seen in Western countries.[2]

Market

While the market has seen the entry of

selective serotonin reuptake inhibitors (SSRIs) fluvoxamine, paroxetine, sertraline, and escitalopram; others such as citalopram and fluoxetine are either pending approval or no longer being considered.[3]

Prior to year 2000 and possibly even later, clinical developments did not use placebo controlled trials; instead they have pitted candidate drugs against those currently approved for that indication using a "non-inferiority" method of comparison. This method is known to be subject to placebo effects (e.g. depressive symptoms lifting due to effects other than

pharmacologic drug effect.)[2] According to a Japanese medical report in 2002, Trazodone and tricyclic antidepressants (TCAs) were widely available in Japan while only two SSRIs (paroxetine and fluvoxamine) were marketed.[4]

Fluvoxamine was the first SSRI to be approved in Japan (1999).[5][6] Sertraline received approval in April 2006, having been pending approval for over 15 years. [7][8]

Currently (as of 2017) the three most sold antidepressants in Japan are duloxetine, mirtazapine, and escitalopram (Lexapro).[9]

The three most sold antidepressants by the end of 2010 were paroxetine with a value market share of 37%, sertraline with a share of 20% and fluvoxamine with a share of 15%.[10]

The Japan algorithm for

Meiji Seika is commercializing mirtazapine (brand name Reflex)[14][15] in Japan which was approved for depression in 2009.[16]

SNRI Duloxetine (Cymbalta - Shionogi and Eli Lilly Japan) was first approved in Japan in 2010 for major depressive disorder.[17][18] In the following years it gained approval for diabetic neuropathy pain, fibromyalgia, chronic low back pain and osteoarthritis.[19][20][21][22]

Glaxo Smith-Kline
), used widely in Western countries since the early 1990s and long in clinical trials in Japan.

Takeda and Lundbeck submitted vortioxetine (Trintellix) to the Ministry of Health, Labour and Welfare in Japan. If approved it may be commercialized in 2019.[24][25]

References

  1. PMID 9987203. Archived from the original
    on 2016-03-06. Retrieved 2007-09-07.
  2. ^ a b c Berger D (Sep 2005). "Antidepressant clinical development in Japan: Current perspectives and future horizons" (PDF). Clinical Research Focus. 16 (7): 32–5.
  3. S2CID 20878837
    .
  4. ^ Kamimura M, Aoba A (2002). "Drug Therapy for Depression in Japan" (PDF).
  5. ^ "Search results detail| Kusurino-Shiori(Drug information Sheet)". www.rad-ar.or.jp. Retrieved 2020-03-16.
  6. PMID 27747476
    .
  7. ^ Life Sciences World - Online resource for biotechnology, pharmaceutical, medical devices and life sciences industries.
  8. ^ "FY2006 List of Approved Products: New Drugs" (PDF). Pharmaceutical and Medical Devices Agency. 2006.
  9. ^ "The Drug Committee of Ministry of Health, Labour and Welfare in Japan has accepted a 2-year extension of market exclusivity of Lexapro®". GlobeNewswire News Room (Press release). 2018-04-27. Retrieved 2020-03-16.
  10. ^ "Lundbeck Launches Antidepressent Lexapro In Japan". Asian Scientist Magazine. 2011-08-27. Retrieved 2018-09-16.
  11. S2CID 8210423
    .
  12. S2CID 25949175
    .
  13. ^ Antidepressant Mirtazapine (Remeron) Submitted For Approval In Japan.
  14. ^ "Meiji Seika Pharma Co., Ltd. | Meiji Holdings". Retrieved 2018-09-16.
  15. ^ "Pharmaceuticals | Meiji Holdings". Retrieved 2018-09-16.
  16. ^ "Meiji Seika Pharma Co., Ltd" (PDF). 2015.
  17. ^ Products Approved in FY 2009: New Drugs. "List of Approved Products" (PDF). Pharmaceuticals and Medical Devices Agency.{{cite web}}: CS1 maint: numeric names: authors list (link)
  18. ^ "Shionogi, Eli Lilly Japan to Comarket Cymbalta". PHARMA JAPAN. Retrieved 2020-03-16.
  19. ^ "Cymbalta was approved today by MHLW for an additional indication of "pain associated with chronic back pain" (PDF).
  20. ^ "Search results detail| Kusurino-Shiori(Drug information Sheet)". www.rad-ar.or.jp. Retrieved 2020-03-16.
  21. ^ "Search results detail| Kusurino-Shiori(Drug information Sheet)". www.rad-ar.or.jp. Retrieved 2020-03-16.
  22. ^ "approval for an additional indication of a serotonin/noradrenalin reuptake inhibitor, Cymbalta" (PDF).
  23. ^ Fraende M (April 22, 2011). "Lundbeck gets Lexapro approval in Japan". Reuters.
  24. ^ "Takeda and Lundbeck Submit New Drug Application (NDA) for Vortioxetine in Japan for the Treatment of Major Depressive Disorder (MDD)". www.takeda.com. Retrieved 2018-12-31.
  25. ^ "Takeda and Lundbeck submit New Drug Application (NDA) for vortioxetine in Japan for the treatment of Major Depressive Disorder (MDD)". H. Lundbeck A/S. Retrieved 2018-12-31.

External links

Further reading

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