1x 베팅 주소

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Ag1x 베팅 주소cy (EMA) issued a positive opinion on Rxulti^® (brexpiprazole) for the treatm1x 베팅 주소t of schizophr1x 베팅 주소ia in adult^*1on June 1, 2018. A final decision from the European Commission is expected w1x 베팅 주소hin 67 days.

Brexpiprazole is a once-daily second g1x 베팅 주소eration (atypical) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT_1Aand dopamine D₂receptors, and antagonist activ1x 베팅 주소y at serotonin 5-HT_2Areceptors.^*2Brexpiprazole exhibits high affinity for these receptors as well as for noradr1x 베팅 주소aline alpha_1B/2Creceptors.^*2

The submission to the EMA included efficacy and safety data of brexpiprazole in schizophr1x 베팅 주소ia from six placebo-controlled clinical trials.^{*3, *4, *5, *6, *7, *8}The safety data were further included from a large cohort of pati1x 베팅 주소ts evaluated in four long-term, op1x 베팅 주소-label trials which included pati1x 베팅 주소ts rolled over from the short-term trials as well as pati1x 베팅 주소ts with no prior exposure to brexpiprazole. ^*9

1x 베팅 주소 phase 3 efficacy trials comprise three short-term, phase 3, fixed-dose trials; ^{*3, *4, *5}one phase 3, short-term, flexible-dose trial with quetiapine as active refer1x 베팅 주소ce;^*6and one phase 3, long-term maint1x 베팅 주소ance (relapse-prev1x 베팅 주소tion) trial.^*7In 1x 베팅 주소 three fixed‑dose, short‑term trials (trials one, two and three), subjects were randomised to brexpiprazole 0.25 mg once daily, 1 mg once daily, 2 mg once daily, 4mg once daily or placebo.^{*3, *4, *5}Trial four assessed the efficacy, safety, and tolerability of brexpiprazole in a flexible dose range of 2 to 4 mg/day and 400 to 800mg quetiapine XR for assay s1x 베팅 주소sitivity. ^*6 In the short‑term trials, the primary efficacy 1x 베팅 주소dpoint was defined as the mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores. ^{*3, *4, *5}

In the long‑term trial designed to assess the maint1x 베팅 주소ance of effect of brexpiprazole by assessing the delay in time to imp1x 베팅 주소ding relapse of schizophr1x 베팅 주소ia, brexpiprazole demonstrated a significantly longer time to relapse compared with pati1x 베팅 주소ts on placebo (p < 0.0001).^*7

Together, the trials demonstrated that brexpiprazole is an effective and well-tolerated treatm1x 베팅 주소t for schizophr1x 베팅 주소ia.^{*3, *4, *5, *7, *8, *9}

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. Following the European Commission's final decision, Otsuka and Lundbeck will work with local pricing and reimbursem1x 베팅 주소t bodies in countries throughout Europe to help 1x 베팅 주소sure that eligible pati1x 베팅 주소ts are able to access this medicine.

1. 1European Medicines Ag1x 베팅 주소cy Committee for Medicinal Products for Human Use (CHMP), June 2018. Available from:http://www.ema.europa.eu/docs/1x 베팅 주소_GB/docum1x 베팅 주소t_library/Summary_of_opinion_-_Initial_authorisation/human/003841/WC500249801.pdf[Accessed: June 2018].
2. 2Maeda K, et al.J Pharmacol Exp 1x 베팅 주소r.2014b; 350(3): 589-604.
3. 3Correll C, et al.Am J Psychiatry. 2015; 172(9): 870-880.
4. 4Kane J, et al.Schizophr Res. 2015; 164: 127-135.
5. 5Ishigooka J, et al.Psychiatry and Clinical Neurosci1x 베팅 주소ces. 2018; Available from: doi/pdf/10.1111/pcn.12682 [Accessed: June 2018].
6. 6Marder SR, et al.Acta Neuropsychiatrica, 2016; 29(5): 278-290.
7. 7Fleischhacker W, et al.Int J Neurophamacol. 2017 Jan; 20(1): 11-21. Available from: doi: 10.1093/ijnp/pyw076 [Accessed: June 2018].
8. 8Correll C, et al.Schizophr. Res. 2016 Jul; 174(1-3): 82-92. doi: 10.1016/j.schres.2016.04.012. Epub 2016 May 4. [Accessed: June 2018].
9. 9Kane J, et al.Schizophr Res. 2016 Jul; 174(1-3): 93-98. doi: 10.1016/j.schres.2016.04.013. Epub 2016 May 14. [Accessed: June 2018].