欧盟委员会批准杨森旗下Trevicta（棕榈酸帕利哌酮一种3个月注射一次的注射剂）用于精神分裂症成年患者的维持治疗。Trevicta在欧盟将使一款抗精神病药物可以提供最长的给药间隔，与目前可供使用的该抗精神病药物的制剂相比，这将允许患者以更少的给药频次使其血液中保持最佳水平的治疗药物。
棕榈酸帕利哌酮的新制剂可以改善患者、照看人及医疗保健专业人员的结局。Trevicta在临床上旨在对Xeplion稳定的成年患者中用于精神分裂症维持治疗，Xeplion是一种1个月用药一次的棕榈酸帕利哌酮产品，其于2011年在欧盟获批用于精神分裂症维持治疗。
在评论此次批准时，杨森神经系统科学与疼痛的欧洲治疗区总监Schreiner 博士称：与其它已获批治疗药物相比，Trevicta每年可以更少的用药频次给精神分裂症患者更大的自由，使他们专注于生活中其它重要的方面，在治疗上用更少的精力。这种新的选择有可能降低疾病复发与进展。它还帮助医疗保健专业人员确保精神分裂症患者能够在用药期间从持续的药物交付中获得受益。
此次批准基于两项3期研究
Trevicta上市许可的授权基于两项3期研究。第一项研究是一项随机、多中心、双盲、安慰剂对照复发预防研究，受试者为500多名精神分裂症患者。第二项研究是一项随机、多中心、双盲研究，该研究将棕榈酸帕利哌酮3个月用药一次的制剂与1个月用药一次制剂的安全性和有效性进行了对比。
Trevicta被发现在预防复发方面至少与1个月用药一次的棕榈酸帕利哌酮制剂一样有效，并且未发现有任何新的或意料之外的安全性信号。在3个月注射一次的棕榈酸帕利哌酮的两项双盲对照临床试验中，≥5% 的患者中报道的最常见药物物不良反应有体重增加、上呼吸道感染、焦虑、头痛、失眠及注射部位反应。
附本品处方资料：http://www.medicines.org.uk/emc/medicine/32050
New Drugs Online Report for paliperidone palmitate
Information
Generic Name: paliperidone palmitate
Trade Name: Trevicta (EU), Invega Trinza (US)
Entry Type: New formulation
Development and Regulatory status
UK: Launched
EU: Launched
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date: June 2016
Comments
Jun 16: Launched in UK [13].
20/06/2016 11:39:28
May 16: Approved in EU for maintenance treatment of schizophrenia in adults [12].
02/06/2016 14:15:27
Apr 16: Granted positive opinion in EU [11].
05/04/2016 11:40:32
Aug 15: Janssen-Cilag announces submission of a license extension application to EMA for paliperidone palmitate once-every-three-months formulation, for treatment of schizophrenia. If approved, it will be marketed as TREVICTA® in Europe [10].
02/09/2015 10:57:02
May 15: Following a priority review, the US FDA has approved atypical antipsychotic Invega Trinza, a three-month injectable formulation of paliperidone palmitate, for the treatment of schizophrenia. Janssen said the drug should be available in the US mid-June [9].
22/05/2015 11:31:19
Jan 15: Remains PIII in the EU [8].
12/03/2015 11:17:09
Jan 15: FDA grants priority review for 3-month Paliperidone Palmitate for treatment of Schizophrenia [7].
20/01/2015 09:25:54
Nov 14: New Drug Application (NDA) submitted to the US FDA [6].
20/11/2014 08:43:28
Feb 14: EU filing will be via the centralised procedure; an application has not yet been filed [5].
01/05/2014 11:07:48
Mar 14: Plan to file in US by end 2014 [4]
21/03/2014 08:12:07
Trial or other data
Mar 15. PIII study (NCT01529515) published in JAMA Psychiatry. In the interim analysis, maintenance treatment with a 3-monthly paliperidone palmitate (PP, n=160) vs. placebo (n=145) showed median time to relapse was 274 days for placebo but not estimable for PP (HR=3.45; 95%CI 1.73-6.88; P<0.001).[9]
01/04/2015 15:33:45
Mar 14: Following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, the Company has halted early a PIII clinical study. The international, randomized, multicenter, double-blind trial (n=509) eva luated the efficacy of paliperidone palmitate 3-month formulation vs placebo in delaying time to first occurrence of relapse of symptoms of schizophrenia. Study patients who were randomized to treatment were first stabilized with paliperidone palmitate one-month formulation. The planned interim analysis was conducted after 60% (42 events, pre-specified) of projected relapses occurred [4].
21/03/2014 08:13:07
Jun 12: NCT01515423 is a multicentre PIII non-inferiority study of paliperidone palmitate 3 month (PP3M) and 1 month (PP1M) formulations for the treatment of 1,288 subjects with schizophrenia. The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label stabilization phase and a 48-week fixed dose, randomized, double-blind controlled phase After screening all patients will receive PP1M with flexible dosing allowed at Weeks 5 and 9. Patients who are clinically stable at the end of the open-label phase will enter the double-blind phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M. The primary outcome is the percentage of patients who have not relapsed at the end of the 48-week double-blind phase. The study started in Apr 12 and is du to complete Nov 14 [2].
13/06/2012 15:27:28
Feb 12: NCT01529515 A PIII randomized, multicenter, double-blind, relapse prevention study of paliperidone palmitate 3 month formulation (175, 263, 350 or 525mg IM injection) for the treatment of 500 subjects with schizophrenia. The study consists of 4 phases: a Screening Phase a 17-week flexible dose open-label Transition Phase; a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase. Patients who meet stabilization criteria will enter the double-blind phase at week 29 and remain in the study until they experience a relapse event or meet discontinuation criteria. The primary outcome is the time to first relapse event in the double-blind phase. Patients must have had schizophrenia for more than 1 year and a total score in the Positive and Negative Syndrome Scale (PANSS) < 120. The study will start Mar 12 and is due to complete Aug 14 [1].
11/02/2012 19:25:14
References
Available only to registered users
Category
BNF Category: Antipsychotic depot injections (04.02.02)
Pharmacology: Dopamine D2 receptor & serotonin 5HT2 receptor antagonist
Epidemiology: In England there are about 800 per 100,000 people with schizophrenia.
Indication: Schizophrenia
Additional Details: 3-monthly IM formulation
Method(s) of Administration
Intramuscular
Company Information
Name: Janssen
US Name: Janssen
Further Information
Anticipated commissioning route (England) CCG
High cost drug list? Awaiting Update
Implications Available only to registered users |
