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Antidepressants in Japan

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The number of new psychiatric drugs, and especially 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

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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 mood disorders[11] does not include many of the post-tricyclic antidepressants used as first-line antidepressants in Western countries for almost two decades, and recent studies are still comparing SSRIs and tricyclic antidepressants, even though tricyclics are 2nd or 3rd line treatments in the West.[12] Organon International and Meiji Seika have filed an application for approval of mirtazapine in Japan, a drug on the market in many Western countries since 1994.[13] 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]

Citalopram (Lundbeck), an SSRI on the market since the late 1980s is not available in Japan; however on April 22, 2011 escitalopram (the S-isomer enantiomer of citalopram), was approved for use.[23] There is little news, however, on the status of bupropion (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

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  1. ^ Kanba S (Jan 1999). "Disparities in drug development: the Japanese paradox". J Psychiatry Neurosci. 24 (1): 13–4. PMC 1188972. 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. ^ Berger D, Fukunishi I (Jul 1996). "Psychiatric drug development in Japan". Science. 273 (5273): 318–9. Bibcode:1996Sci...273..318B. doi:10.1126/science.273.5273.318. PMID 8685717. 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. ^ Asakura S, Koyama T, Hosokai T, Kawano H, Kajii Y (2014-10-30). "Post-Marketing Surveillance of Fluvoxamine Maleate Used Long-Term in Patients with Social Anxiety Disorder in Japan". Drugs - Real World Outcomes. 1 (1): 7–19. doi:10.1007/s40801-014-0005-2. ISSN 2199-1154. PMC 4883186. 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. ^ Nomura S, Sawamura T, Kobayashi N, Yoshino A (Sep 2004). "Medication algorithm for mood disorders: Present status and future direction in Japan". International Journal of Psychiatry in Clinical Practice. 8 (3): 139–45. doi:10.1080/13651500410005432-1. PMID 24926843. S2CID 8210423.
  12. ^ Otsubo T, Akimoto Y, Yamada H, et al. (Jan 2005). "A comparative study of the efficacy and safety profiles between fluvoxamine and nortriptyline in Japanese patients with major depression". Pharmacopsychiatry. 38 (1): 30–5. doi:10.1055/s-2005-837769. PMID 15706464. 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.
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Further reading

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