Navigation Links
INVEGA(TM) Gets Marketing Authority from EU to Treat Schizophrenia

TITUSVILLE, N.J., The European Commission granted marketing authorization for INVEGA(TM) (paliperidone prolonged release tablets), an atypical antipsychotic medication for the treatment of schizophrenia. This once-daily medication is specifically designed to deliver paliperidone - the active ingredient in INVEGA - through the innovative osmotic delivery system (OROS(R)).

In clinical trials, INVEGA demonstrated significant efficacy as compared to placebo in helping many patients control the symptoms of schizophrenia, and it was generally well tolerated.

INVEGA (paliperidone prolonged release tablets) will be marketed in Europe by Janssen-Cilag. In the U.S., this product is marketed by Janssen, L.P. as INVEGA (paliperidone) Extended-Release Tablets. This approval represents another important milestone in the company's long-standing commitment to develop new treatment options for serious mental illnesses.

INVEGA is the first and only treatment for schizophrenia to receive marketing authorization in the EU that uses the osmotic delivery system (OROS(R)). The decision of the European Medicines Agency to grant marketing authorization for INVEGA in Europe is based on efficacy and safety results of an extensive clinical development program that included: three six-week, placebo controlled clinical studies involving more than 1,600 patients with acute schizophrenia in 23 countries,(i) a longer-term (up to 40 weeks) double blind, placebo controlled study in 207 randomized patients(ii) examining time to relapse, and another double blind, placebo controlled study assessing safety and tolerability in 114 elderly patients suffering from schizophrenia.(iii)

The primary measure of efficacy was the Positive and Negative Syndrome Scale (PANSS), a tool commonly used in schizophrenia research that measures the severity of positive and negative symptoms and general psychopathology. The Personal and Social Performance Scale (PSP), a measure of functional improvement, as well as safety and tolerability assessments, were also included in the trials that supported the approval of INVEGA. The recommended dose of INVEGA is 6 mg per day, with a dose range of 3 mg to 12 mg per day depending on patient need.

Key findings of the program include:

-- In three six-week clinical trials, INVEGA demonstrated statistically significant symptom improvement on the PANSS versus placebo across all doses investigated. INVEGA was also superior to placebo on the PSP in these trials. In a chronic treatment trial, adult patients with schizophrenia who were treated with INVEGA showed a significantly longer time to relapse compared to placebo.
-- From the three six-week clinical trials, treatment-emergent adverse events(iv) (TEAEs) reported in 5% or more of subjects treated with INVEGA and at least twice the placebo rate for at least one dose included: akathisia (i.e. restlessness) and extrapyramidal disorder e.g. involuntary movements, tremors or muscle stiffness).
-- In the three six-week clinical trials, discontinuation rates due to TEAEs for all INVEGA dose groups were low and comparable to placebo (5% for placebo and for INVEGA: 2% for 3 mg, 6% for 6 mg, 4% for 9 mg, 5% for 12 mg).

Worldwide, it is estimated that 1 person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected in nearly equal numbers. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions, and social withdrawal), as well as by disorganized thinking.

INVEGA was approved in the U.S. in December 2006, and was the first new prescription treatment for schizophrenia to be approved by the U.S. FDA since 2003. In April 2007, INVEGA was also approved by the FDA for the long -term maintenance treatment of schizophrenia. INVEGA was discovered and jointly developed by ALZA Corporation and Johnson & Johnson Pharmaceutical Research and Development, LLC.
'"/>




Related medicine news :

1. FDA To Set New Guidelines To Revise Drug Companies Marketing Tactics
2. Junk Food Marketing to be banned
3. Government Should Restrict Junk Food Marketing
4. Kellogg Warned Against Its Marketing Strategies
5. Marketing of Low Tar Cigarette Brand by BAT Unethical
6. Bayer Wins Positive Response For Marketing Its Cancer Drug
7. Co-op to Stop Marketing Diabetic Food
8. Measures to Streamline Marketing of Breast-Milk Substitutes
9. Marketing in Schools may Discourage Healthy Nutrition among Students
10. Viagra Marketing Campaign, ‘a Cause of Concern’, Say Anti-AIDS Grop
11. Effective Marketing of Multivitamins Essential
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/20/2017)... ... June 20, 2017 , ... ... in Cincinnati, OH for leading-edge care, whether or not they have a referral. ... the BIOLASE WaterLase® iPlus™ laser, she targets bacteria and damaged tissue without affecting ...
(Date:6/20/2017)... ... June 20, 2017 , ... Many RNA binding proteins ... the research team developed expressRNA, a web platform encompassing computational tools for integration ... nucleotide resolution the ‘RNA maps’, which demonstrate that RBPs bind to specific positions ...
(Date:6/20/2017)... ... June 20, 2017 , ... John D'Eri, CEO of Rising Tide ... Adult Autism Award during the Autism Society of America 's 49th annual ... Daniel Jordan Fiddle Foundation (DJFF) was founded in 2002 as the nation's first ...
(Date:6/20/2017)... , ... June 20, 2017 , ... ... McKenna has joined the company as Vice President of Sales, a critical role ... continued growth and increased customer satisfaction. , Mr. McKenna is a seasoned business ...
(Date:6/19/2017)... ... 2017 , ... Haute Beauty welcomes Dr. Hayes Gladstone, a ... and wellness experts. , With two decades of experience in reconstructive and aesthetic ... restoration. , Heading the successful Gladstone Clinic in San Ramon, ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... , June 5, 2017 Kohll,s Pharmacy ... the United States . The Raizer is ... a fallen person up to an almost-standing position ... and operated by one assistant and does not ... is simple enough that a child can operate it, ...
(Date:6/2/2017)... 2017  NxStage Medical, Inc. (Nasdaq:  NXTM), a leading medical technology ... findings demonstrating positive biochemical outcomes related to more frequent ... data will be presented at the ERA-EDTA Congress being ... . The research was conducted ... in Europe (KIHDNEy) Cohort ...
(Date:5/30/2017)... DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with ... be presenting at the 7th annual LD Micro Invitational on Tuesday, ... CEO, of DarioHealth will be giving the presentation and meeting with ... & 7th, 2017 at the Luxe Sunset Bel Air Hotel and ... About LD Micro LD Micro was ...
Breaking Medicine Technology: