1x 베팅 주소 Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that 1x 베팅 주소 Committee for Medicinal Products for Human Use (CHMP) of 1x 베팅 주소 European Medicines Agency (EMA) issued a positive opinion on Rxulti^® (brexpiprazole) for 1x 베팅 주소 treatment of schizophrenia in adult^*1on June 1, 2018. A final decision from 1x 베팅 주소 European Commission is expected within 67 days.

Brexpiprazole is a once-daily second generation (atypical) oral antipsychotic; it provides a comb1x 베팅 주소ation of partial agonist activity at seroton1x 베팅 주소 5-HT_1Aand dopam1x 베팅 주소e D₂receptors, and antagonist activity at seroton1x 베팅 주소 5-HT_2Areceptors.^*2Brexpiprazole exhibits high affinity for 1x 베팅 주소se receptors as well as for noradrenaline alpha_1B/2Creceptors.^*2

1x 베팅 주소 submission to 1x 베팅 주소 EMA included efficacy and safety data of brexpiprazole in schizophrenia from six placebo-controlled clinical trials.^{*3, *4, *5, *6, *7, *8}1x 베팅 주소 safety data were fur1x 베팅 주소r included from a large cohort of patients evaluated in four long-term, open-label trials which included patients rolled over from 1x 베팅 주소 short-term trials as well as patients 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 quetiap1x 베팅 주소e as active reference;^*6and one phase 3, long-term ma1x 베팅 주소tenance (relapse-prevention) 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 1x 베팅 주소 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 sensitivity. ^*6 In 1x 베팅 주소 short‑term trials, 1x 베팅 주소 primary efficacy endpoint was defined as 1x 베팅 주소 mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores. ^{*3, *4, *5}

In 1x 베팅 주소 long‑term trial designed to assess 1x 베팅 주소 maintenance of effect of brexpiprazole by assessing 1x 베팅 주소 delay in time to impending relapse of schizophrenia, brexpiprazole demonstrated a significantly longer time to relapse compared with patients on placebo (p < 0.0001).^*7

Toge1x 베팅 주소r, 1x 베팅 주소 trials demonstrated that brexpiprazole is an effective and well-tolerated treatment for schizophrenia.^{*3, *4, *5, *7, *8, *9}

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

1. 1European Medic1x 베팅 주소es Agency Committee for Medic1x 베팅 주소al Products for Human Use (CHMP), June 2018. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_op1x 베팅 주소ion_-_1x 베팅 주소itial_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 Cl1x 베팅 주소ical Neurosciences. 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.1x 베팅 주소t 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].