ルラシドン

ルラシドン

Material name by the IUPAC glossology
IUPAC name (3aR,4S,7R,7aS) -2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione
Clinical data
Fetus degree of risk classification	US: B
Dosage method	oral
Pharmacokinetics data
Bioavailability	9-19% (Oral)[1]
Metabolism	CYP3A4 [1]
Half-life	18h [1]
Excretion	Faecal (~80%), Renal (~9%)[1]
Identification
CAS number (MeSH)	367,514-87-2
ATC cord	N05AE05 (WHO)
PubChem	CID: 213046
Chemical data
Chemical formula	C28H36N4O2S
Molecular weight	492.676 g/mol
SMILES C1CCC(C(C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)C6C7CCC(C7)C6C5=O

ルラシドン (Lurasidone, a brand name: ラツーダ) is the non-fixed form antipsychotic which Dainippon Sumitomo Pharma Co., Ltd. is developing.

ルラシドン intercepts dopamine D₂ receptor, serotonin 5-HT_2A receptor, serotonin 5-HT₇ receptor and has partial operation characteristics to serotonin 5-HT_1A receptor [²]. It does not act for a histamine receptor and the muscarinic receptor. It is said that I do not cause an extrapyramidal sign than conventional non-fixed form antipsychotic.

Approval situation

I am classified in third generation antipsychotic. After having performed the acquisition [³] of sale permission in the United States in October, 2010, I acquired approval [⁵] in Switzerland in Canada in [⁴], August, 2013 in June, 2012, and I accept the examination result of recommending approval, and the approval of the Europe pharmaceutical products agency (EMA) is waited for in Europe in February, 2014 by the European pharmaceutical products evaluation committee (CHMP) [²].

Development in Japan

A third aspect clinical trial (PASTEL examination) was carried out for the purpose of approval application in Japan. As a result of 439 patients being randomly assigned to ルラシドン 40 mg/day, 80 mg/day, three groups of the placebo group, and having given it six weeks, (40 mg: -17.9, 80 mg: -17.3) that the amount of change of the main end-point-positive negative symptom evaluation standard (PANSS: Positive and Negative Syndrome Scale) showed an improvement trend to for a placebo (-13.1), as for the statistical significant difference, it was not admitted [⁶]. But significant difference was recognized when I changed the analysis population (modified ITT) to ITT (n=450) (40 mg/day of administrated groups: -17.7, 80 mg/day of administrated groups: -16.8, the placebo administrated group: -11.9). In addition, there is not the significant difference about clinical whole impression evaluation standard - disease severity (CGI-S: Clinical Global Impressions-Severity of Illness scale) of the secondary end-point [⁷].

Footnote

[Help]

1. ^ ^{a b c d} Truven Health Analytics, Inc. DrugPoint®System (Internet) [cited 2013 Oct 1]. Greenwood Village, CO: Thomsen Healthcare; 2013.
2. ^ ^{a b} "An examination result of CHMP about non-fixed form antipsychotic ルラシドン clearly". QLife Pro (February 4, 2014). April 25, 2015 reading.
3. To ^ "[Dainippon Sumitomo Pharma Co., Ltd.] schizophrenia medicine "ラツーダ" U.S. FDA sale permission - next March overseas advance." A pharmaceutical daily report (October 29, 2010). April 25, 2015 reading.
4. ^ "About the approval acquisition in Canada of non-fixed form antipsychotic "LATUDA™"". Dainippon Sumitomo Pharma Co., Ltd. (June 16, 2012). April 25, 2015 reading.
5. ^ "About the sale permission approval acquisition of non-fixed form antipsychotic "ルラシドン" in Switzerland". Takeda Pharmaceutical Co., Ltd. (August 13, 2013). April 25, 2015 reading.
6. "The analysis result of the third aspect clinical trial (PASTEL examination) for ^ schizophrenia of [http://www.ds-pharma.co.jp/pdf_view.php?id=667 (followup) non-fixed form antipsychotic ルラシドン]." Dainippon Sumitomo Pharma Co., Ltd. (April 24, 2015). April 25, 2015 reading.
7. ^ "About the breaking news of the analysis result of the third aspect clinical trial (PASTEL examination) for schizophrenia of non-fixed form antipsychotic ルラシドン". Dainippon Sumitomo Pharma Co., Ltd. (December 25, 2014). April 25, 2015 reading.

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