http://uk.biz.yahoo.com/02072007/250/new-treatment-schizophrenia-licensed-uk.html
Tuesday July 3, 12:03 AM
New Treatment for Schizophrenia Licensed in the UK
SAUNDERTON, England, July 3 /PRNewswire/ --
- ATTN: UK Editors Only
Today, Janssen-Cilag Ltd has announced the authorisation of INVEGA(R) (paliperidone), a new treatment for schizophrenia.(1) Schizophrenia can have a major detrimental effect on people's personal, social and occupational lives leading to difficulty in daily living.(2) In clinical trials, people treated with paliperidone experienced reductions in the positive and negative symptoms of schizophrenia, as well as improvements in day-to-day personal and social functioning.(3)-(5)
Paliperidone (prolonged-release tablets) is the first and only atypical antipsychotic treatment for schizophrenia to use the innovative OROS prolonged-release technology that provides a steady release of medicine over a 24-hour period.(6) The smooth release of medicine reduces fluctuations of drug levels in the blood(5) experienced with some other existing treatments for schizophrenia.
[BLOG EDIT NOTE: ITS AN ATYPICAL ANTIPSYCHOTIC, AS IS ZYPREXA etc, AND THE 'PROLONGED RELEASE' IS WHATS 'NEW' and 'INNOVATIVE' ABOUT IT]
The once a day oral tablet which delivers smooth and constant medication release over 24 hours(6), offers a new treatment option for the one in 100 people in the UK who experience schizophrenia.(7),(8)
National mental health advocacy organisations recognise the importance of new treatments for schizophrenia. "We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia," said Marjorie Wallace, Chief Executive at the mental health charity Sane "New treatment options such as Paliperidone are a significant opportunity for more people with schizophrenia to effectively manage their disease, working with their medical team to live more fulfilling and productive lives."
The authorisation of paliperidone (prolonged-release tablets) is based on results of an extensive clinical development programme enrolling over 1,200 patients in 23 countries around the world as part of three pivotal studies.(3)-(5)
Janssen-Cilag has been at the forefront of new advancements in mental health for over 50 years having launched Haldol in 1958, Risperdal Oral in the early 1980s and more recently, Risperdal Consta, a long-acting injectable antipsychotic.
"Paliperidone is a new atypical antipsychotic with an innovative delivery system that can offer a more consistent release of medication," explained Dr. Helen Millar, Consultant Psychiatrist at the Carseview Centre, Dundee, Scotland. "Clinical trials have shown that paliperidone is effective and generally well tolerated. Effective treatments for people with schizophrenia are important in helping to improve everyday functioning."
Worldwide, it is estimated that one person in every 100 develops schizophrenia, a serious type of mental illness, which can effect men and women equally, often appearing between the ages of 15-25 and 25-35, for men and women respectively.(7),(8) The disease may effect individual patients throughout their lives, with relapses being marked by positive symptoms (hallucinations, delusions and disorganised thinking) and negative symptoms (depression, blunted emotions and social withdrawal).(8)
The costs of schizophrenia include direct costs (such as the costs of hospitalisation, drug costs, wages of healthcare professionals), and indirect costs (such as social security benefits and other social costs involved in supporting patients). The total direct treatment costs of schizophrenia in England and Wales are estimated to be in excess of GBP1 billion, or around 3% of the total NHS expenditure. Hospitalisations account for the majority of this expenditure (and for approximately 5% of total NHS inpatient expenditure), while drug costs account for 5% only of the direct costs of schizophrenia. Indirect costs of schizophrenia in the UK are estimated to be at least GBP1.7 billion.(9)
Notes to Editor:
INVEGA prolonged release tablets were developed by Johnson & Johnson Pharmaceutical Research and Development (J&JPRD). INVEGA prolonged release tablets have been authorised by the Food and Drug Administration since December 2006 and is marketed by Janssen, L.P. in the United States. Upon authorisation by the European Commission, INVEGA prolonged release tablets will be marketed in Europe by the Janssen-Cilag companies.
Janssen-Cilag Ltd (www.janssen-cilag.co.uk), manufacturer of Risperdal(R) Consta(TM), Risperdal(R) (risperidone) and Risperdal(R) Quicklet(TM) is part of the Johnson & Johnson (NYSE: JNJ - news) family of companies, a leading research-based pharmaceutical company, with more than 110,000 employees worldwide and establishments in approximately 50 countries.
References:
(1). Summary of Product Characteristics of INVEGA (paliperidone) prolonged-release tablets, May 2007.
(2). The National Institute of Clinical Excellence. Schizophrenia - Full national clinical guideline on core interventions in primary and secondary care. 2003
(3). Marder S, et al. A 6-week US-based placebo-controlled study on the efficacy and tolerability of two fixed dosages of oral paliperidone extended-release tablets in the treatment of acute schizophrenia. Poster presented at APA May 2006; Toronto, Canada, 20-25.
(4). Davidson M. et al. Efficacy (EFCY.PK - news) , safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study. Schizophrenia Research. 2007: 93; 117 130.
(5). Kane J, et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial, Schizophrenia Research. 2006: 90; 147-161.
(6). Karlsson P, et al. Pharmacokinetics, and dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone extended-release in healthy subjects. Poster presented at WWS; Davos, Switzerland, (5)-11 February 2006.
(7). http://www.patient.co.uk/showdoc/23069111/: (last updated November 2006)
(8). Lehman AF, et al. American Psychiatric Association. Practice guidelines for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56.
(9). The National Institute of Clinical Excellence. Guidance of the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia. June 2002. "