Strong growth-resistant antipsychotic drugs are FDA-approved label update
January 04, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Janssen Pharma, a US pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has approved a monthly infusion of a long-acting version of the atypical antipsychotic drug Invega Sustenna (paliperidone palmitate). The ketone sustained-release injection) label was updated to incorporate data from the landmark real-world research PRIDE.
This approval made Invega Sustenna the first and only antipsychotic drug that incorporates real-world data into the label, and is the first and only one in a common group of schizophrenia adult patients. A commonly used prescription oral antipsychotic drug exhibits significant superiority.
Data from the PRIDE study confirmed: (1) Invega Sustenna showed superior efficacy compared with a group of seven commonly prescribed oral antipsychotics in delaying the recurrence of schizophrenia; (2) with a group of 7 Invega Sustenna significantly delayed the time of psychiatric hospitalization or arrest and/or detention in patients with schizophrenia compared to common prescription oral antipsychotics. This milestone data is expected to break the cycle of hospitalization and imprisonment associated with schizophrenia.
Martha Sajatovic, MD, researcher at PRIDE Research and director of the Center for Neurological and Behavioral Prognosis at the Cleveland Clinic, said that this important study has helped us better understand the therapeutic effects of antipsychotic drugs outside the controlled environment of typical clinical trials, such as psychiatry. Hospitalization, imprisonment and drug abuse are a very unfortunate reality for people with schizophrenia. Health care providers often provide oral antipsychotics to patients with schizophrenia without providing long-acting therapies until the end of the disease. Based on the comparative evidence added in the Invega Sustenna label, health care professionals should now consider the clinical benefits of long-term therapy for early treatment in the treatment of adult patients with schizophrenia.
The results from the PRIDE study have the potential to address more critical issues in the healthcare system. In the United States, the criminal justice system is currently the largest provider of mental health care, in part because medical services are not the same. Patients with severe mental illness (SMI, including schizophrenia) living in the United States often have three times more likely to be imprisoned or imprisoned because of the onset of the disease than they are admitted to hospital. Despite the widespread use of antipsychotic drugs, sometimes it is difficult for patients to take prescribed medications, which increases the risk of recurrence of symptoms that result in expensive related events, such as hospitalization or imprisonment.
Michelle Kramer, vice president of neuroscience medical affairs at Yangsen, said that when treatment failures and schizophrenia recurrence, not only the individual patients and their families are very depressed and difficult, but also can impose heavy burdens and expensive expenses on the entire healthcare system. The inclusion of new evidence in the Invega Sustenna drug label will help schizophrenic patients and their health care providers understand the correct treatment plan and medical support to prevent disease recurrence.
PRIDE Research: Milestone data is expected to break the old loop
The PRIDE study was a 15-month, multicenter, prospective, randomized, open-label, active-controlled study that enrolled 444 adult adults with schizophrenia at 50 treatment centers across the United States and Puerto Rico.
The study was specifically designed to reflect the population of schizophrenia patients commonly seen by health care professionals in clinical practice. All patients enrolled were adult patients diagnosed with schizophrenia and were detained at least twice in the criminal justice system in the past 2 years, at least once in custody leading to imprisonment. The study allows patients with schizophrenia who are often excluded from clinical trials, such as those with a recent history of imprisonment, and those who have reported self-reported drug abuse or alcohol abuse prior to clinical trial registration, or A patient diagnosed with a drug abuse disorder. Patients who had abused intravenous drugs or had opioid dependence during the 3-month screening period were not included in the study.
In this study, patients were randomized to receive one monthly intramuscular injection of Invega Sustenna or one of the seven most commonly prescribed antipsychotics prescribed in the United States (including: aripiprazole, haloperidol) Alcohol, olanzapine, paliperidone, hydroxypiperazine, quetiapine, risperidone). Clinicians can determine appropriate oral antipsychotic medications based on their previous treatment experience, which is typical in the real world. It should be noted that the purpose of the study was not to compare the efficacy of Invega Sustenna with oral antipsychotics that are routinely prescribed in every patient in the study. The primary endpoint of the study was the median time to the first treatment failure or relapse.
The results of the study showed that the relapse time of the Invega Sustenna treatment group was significantly delayed by 6 months compared with the 7 commonly used oral antipsychotic treatment groups (median 416 days vs median 226 days, p=0.011). In addition, a statistically significant delay in the timing of the first psychiatric hospitalization or arrest and/or imprisonment occurred.
In this study, treatment failure was defined as psychiatric hospitalization, arrest/imprisonment, suicide, and treatment supplementation or discontinuation of antipsychotic medications due to inadequate efficacy, safety or tolerability, or the need to increase psychiatric services to prevent impending The hospitalization of the mental illness occurred.
In terms of safety, no new security issues were discovered during the study. In a previous placebo-controlled study, the adverse effects of the Invega Sustenna treatment group (≥5% and twice the placebo group) included injection site reactions, lethargy/sedation, dizziness, sedation, and extrapyramidal disease. During the PRIDE study, the most common adverse events in Invega Sustenna's treatment group (incidence ≥ 5% and twice the oral antipsychotic treatment group) were pain at the injection site, weight gain, fatigue, erectile dysfunction, and decreased libido.
Schizophrenia is a complex, chronic brain disease that can be severely disabling. It is estimated that the disease affects approximately 2.4 million adults in the United States. The condition usually begins in the teens or in the twenties, and includes specific thoughts and behaviors of hallucinations, delusions, and disorders.
Invega Sustenna was approved by the US FDA in July 2009 and became the first monthly, atypical, long-acting injection for the treatment of schizophrenia. As of now, the drug has been approved by more than 80 countries around the world. In November 2014, the FDA approved the drug for the treatment of emotional schizophrenic disorders, becoming the first and only monthly drug to treat the disease. However, patients with emotionally dilated mental disorders have not been studied as part of the PRIDE study.
In May 2015, Invega Sustenna's upgraded version of Invega Trinza was approved by the US FDA for the treatment of schizophrenia, which is administered intramuscularly every 3 months and requires only 4 injections per year. Invega Trinza is approved by the FDA's priority review process and is the world's first and only schizophrenia treatment for only 4 times a year. (Sina Pharmaceutical Compilation/newborn)
Article Reference Source: LANDMARK SCHIZOPHRENIA DATA THAT BRINGS HOPE IN BREAKING THE CYCLE OF HOSPITALIZATION AND INCARCERATION RECEIVES FDA APPROVAL FOR INCLUSION IN INVEGA SUSTENNA® (paliperidone palmitate) LABEL
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