Antidepressants in Japan

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 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 the selective serotonin reuptake inhibitors (SSRIs) fluvoxamine (Luvox-Fujisawa, Depromel-Meiji Seika), paroxetine (Paxil-GSK), sertraline (Zoloft-Pfizer), and the SNRI milnacipran (Toledomin-Asahi Kasei-Janssen), other antidepressants including citalopram (Cipramil/Cipralex-Lundbeck), fluoxetine (Prozac-Eli Lilly) and others are either still under investigation in Japan or have dropped their pursuit on gaining entry into the Japanese market.[3]

Although none of the antidepressants on the market in Japan have been studied using placebo controls, this had begun to change since the beginning of the 2000s. Prior clinical developments have pitted the new drug against a drug already on the market using a non-inferiority method of comparison, however, this method is known to be subject to placebo effects, e.g. depressive symptoms lifting due to effects other than pharmacologic drug effect.[2] In a randomized double-blind, placebo-controlled study, fluvoxamine was superior to placebo for General Anxiety Disorder.[4]

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.[5] A third SSRI, sertraline, received approval in April 2006 after over 15 years of clinical trial development in Japan.[6][7]

The three most sold antidepressants in Japan were 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%.[8]

The Japan algorithm for mood disorders[9] 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 clearly 2nd or 3rd line treatments in the West.[10] 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.[11] Meiji Seika is commercializing mirtrazapine(brand name Reflex)[12][13] in Japan which was approved for depression in 2009.[14]

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 in Japan.[15] 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.

Tadeka and Lundbeck submitted vortioxetine to the Ministry of Health, Labour and Welfare in Japan. If approved it may be commercialized in 2019.[16][17]

References
  1. Kanba S (Jan 1999). "Disparities in drug development: the Japanese paradox". J Psychiatry Neurosci. 24 (1): 13–4. PMC 1188972. PMID 9987203.
  2. 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. doi:10.1126/science.273.5273.318. PMID 8685717.
  4. Asakura, Satoshi; Tajima, Osamu; Koyama, Tsukasa (2006-03-30). "Fluvoxamine treatment of generalized social anxiety disorder in Japan: a randomized double-blind, placebo-controlled study". The International Journal of Neuropsychopharmacology. 10 (2): 263. doi:10.1017/S1461145706006602. ISSN 1461-1457. PMID 16573847.
  5. Kamimura, Makoto; Aoba, Anri (2002). "Drug Therapy for Depression in Japan" (PDF).
  6. Life Sciences World - Online resource for biotechnology, pharmaceutical, medical devices and life sciences industries.
  7. "FY2006 List of Approved Products: New Drugs" (PDF). Pharmaceutical and Medical Devices Agency. 2006.
  8. "Lundbeck Launches Antidepressent Lexapro In Japan". Asian Scientist Magazine | Science, technology and medical news updates from Asia. 2011-08-27. Retrieved 2018-09-16.
  9. 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.
  10. 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.
  11. Antidepressant Mirtazapine (Remeron) Submitted For Approval In Japan.
  12. "Meiji Seika Pharma Co., Ltd. | Meiji Holdings". Retrieved 2018-09-16.
  13. "Pharmaceuticals | Meiji Holdings". Retrieved 2018-09-16.
  14. "Meiji Seika Pharma Co., Ltd" (PDF). 2015.
  15. Fraende, Mette (April 22, 2011). "Lundbeck gets Lexapro approval in Japan". Reuters.
  16. "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.
  17. "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.

Further reading
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