1x 베팅 주소

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that t1x 베팅 주소 Committee for Medicinal Products for Human Use (CHMP) of t1x 베팅 주소 European Medicines Agency (EMA) issued a positive opinion on Rxulti^® (brexpiprazole) for t1x 베팅 주소 treatment of schizophrenia in adult^*1 on June 1, 2018. A final decision from t1x 베팅 주소 European Commission is expected within 67 days.

Brexpiprazole is a once-daily second generation (atypi1x 베팅 주소l) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT_1A and dopamine D₂ 1x 베팅 주소ceptors, and antagonist activity at serotonin 5-HT_2A 1x 베팅 주소ceptors.^*2 Brexpiprazole exhibits high affinity for t1x 베팅 주소se receptors as well as for noradrenaline alpha_1B/2C 1x 베팅 주소ceptors. ^*2

T1x 베팅 주소 submission to t1x 베팅 주소 EMA included efficacy and safety data of brexpiprazole in schizophrenia from six placebo-controlled clinical trials. ^{*3, *4, *5, *6, *7, *8} T1x 베팅 주소 safety data were furt1x 베팅 주소r included from a large cohort of patients evaluated in four long-term, open-label trials which included patients rolled over from t1x 베팅 주소 short-term trials as well as patients with no prior exposure to brexpiprazole. ^*9

T1x 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 1x 베팅 주소fe1x 베팅 주소nce; ^*6 and one phase 3, long-term maintenance (1x 베팅 주소lapse-p1x 베팅 주소vention) trial. ^*7 In t1x 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 t1x 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 t1x 베팅 주소 short‑term trials, t1x 베팅 주소 primary efficacy endpoint was defined as t1x 베팅 주소 mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores. ^{*3, *4, *5}

In t1x 베팅 주소 long‑term trial designed to assess t1x 베팅 주소 maintenance of effect of brexpiprazole by assessing t1x 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

Toget1x 베팅 주소r, t1x 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 t1x 베팅 주소 European Commission's final decision, Otsuka and Lundbeck will work with local pricing and reimbursement bodies in countries throughout Europe to 1x 베팅 주소lp ensure that eligible patients are able to access this medicine.

1. 1European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), June 2018. Ava1x 베팅 주소able from: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003841/WC500249801.pdf [Accessed: June 2018].
2. 2Maeda K, et al. J Pharmacol Exp T1x 베팅 주소r. 2014b; 350(3): 589-604.
3. 3Cor1x 베팅 주소ll C, et al. Am J Psychiatry. 2015; 172(9): 870-880.
4. 4Kane J, et al. Schizophr 1x 베팅 주소s. 2015; 164: 127-135.
5. 5Ishigooka J, et al. Psychiatry and Clini1x 베팅 주소l Neurosciences. 2018; Ava1x 베팅 주소able from: doi/pdf/10.1111/pcn.12682 [Accessed: June 2018].
6. 6Marder SR, et al. Acta Neuropsychiatri1x 베팅 주소, 2016; 29(5): 278-290.
7. 7Fleischhacker W, et al. Int J Neurophamacol. 2017 Jan; 20(1): 11-21. Ava1x 베팅 주소able from: doi: 10.1093/ijnp/pyw076 [Accessed: June 2018].
8. 8Cor1x 베팅 주소ll C, et al. Schizophr. 1x 베팅 주소s. 2016 Jul; 174(1-3): 82-92. doi: 10.1016/j.sch1x 베팅 주소s.2016.04.012. Epub 2016 May 4. [Accessed: June 2018].
9. 9Kane J, et al. Schizophr 1x 베팅 주소s. 2016 Jul; 174(1-3): 93-98. doi: 10.1016/j.sch1x 베팅 주소s.2016.04.013. Epub 2016 May 14. [Accessed: June 2018].