INVEGA® Licensed In The UK As New Treatment For Schizophrenia

Main Category: Schizophrenia
Also Included In: Psychology / Psychiatry
Article Date: 06 Jul 2007 - 1:00 PDT

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Janssen-Cilag has announced that the European Medicines Agency (EMEA) has authorised INVEGA (paliperidone prolonged-release tablets), a new once-daily atypical antipsychotic medication, for the treatment of schizophrenia.1 At the recommended dose of 6mg1, INVEGA has demonstrated a significant and meaningful improvement in the symptoms of schizophrenia, reducing positive and negative symptoms that disrupt the lives of people with schizophrenia and has also shown to be generally well tolerated, in clinical trials.2-4

INVEGA, a new chemical entity, is the first and only atypical antipsychotic treatment for schizophrenia to use the innovative OROS prolonged-release technology that provides a consistent release of medicine over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations.5 The steady release of medicine provides simple once a day dosing, without the need for dose titration.2-4

In another first, within the clinical studies of INVEGA improvements in patient social and personal functioning as measured by the novel Personal and Social Performance Scale* were demonstrated.2-4 Achieving improvements in personal and social functioning is an important objective to allow many people to begin to rebuild their lives after experiencing the debilitating effects of schizophrenia.

"INVEGA 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 in Dundee, Scotland. "Clinical trials have shown that Invega delivers a combination of significant efficacy with a favourable tolerability profile. In the real world this combination translates to improved personal and social functioning for patients living with schizophrenia. Of particular interest is that for the first time, these improvements have been measured using the novel Personal and Social Performance Scale."

National mental health advocacy organisations also 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 INVEGA 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 INVEGA is based on results of an extensive clinical development programme enrolling over 1,200 patients in 23 countries around the world as part of 3 pivotal studies.2-4

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.6 Patient functioning and other measures of efficacy and tolerability were also included in these trials supporting authorisation of INVEGA.2-4

Key findings of the clinical research programme2-4 include:

- In a pooled analysis of the three pivotal trials, all doses of INVEGA demonstrated significant improvements in mean total score and in each of the five factor scores of the PANSS versus placebo.2-4

- Many patients on INVEGA experienced statistically significant symptom improvement versus placebo as early as day four, at the recommended 6mg dose.2

- As early as Day 4, INVEGA 6mg demonstrated a statistically significant separation from placebo on the total PANSS that was maintained for the remainder of the study.2

- INVEGA demonstrated significant improvements in patient functioning versus placebo as measured by the Personal and Social Performance (PSP*) scale.4 INVEGA is the first treatment for schizophrenia to receive EMEA authorisation for inclusion of social functioning (PSP scale) in its product labelling.

- The specific treatment-emergent adverse eventsi (TEAEs) associated with INVEGA, which occurred at a rate of greater than or equal to five percent and twice that of placebo in any of the dosing arms were hyperkinesias (excessive muscle movement) and extrapyramidal disorders (e.g., involuntary movement, tremors or rigidity).4

- INVEGA is not extensively metabolised by the liver and is excreted largely unchanged through the kidney. Therefore, it is not expected to cause certain clinically important drug-drug interactions with medicines metabolised by the main enzyme systems of the liver.4

- Discontinuation rates due to adverse events for all INVEGA dose groups were low and comparable to placebo (6% for placebo and for INVEGA: 2% for 3 mg, 7% for 6 mg, 4% for 9 mg, 5% for 12 mg).3,4

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness, which affects both men and women equally between the ages of 15-25 and 25-35, respectively.7,8 The disease is marked by positive symptoms (hallucinations, delusions and disorganised thinking) and negative symptoms (depression, blunted emotions and social withdrawal).8

Many patients have had experience with INVEGA through the three pivotal clinical trials that started in 2005 and since its US launch in January 2007, it has been prescribed by more than 8,700 clinicians. INVEGA was developed by Johnson & Johnson Pharmaceutical Research and Development, L.L.C and is another important milestone in the continual commitment of Janssen-Cilag UK Ltd to provide innovative and improved treatment options to enhance the lives of people with schizophrenia.

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® Consta™, Risperdal® (risperidone) and Risperdal® Quicklet™ is part of the Johnson & Johnson family of companies, a leading research-based pharmaceutical company, with more than 110,000 employees worldwide and establishments in approximately 50 countries.

* The PSP scale is a validated, clinician-rated scale that measures personal and social functioning in four domains of behaviour: socially useful activities, including work and study, personal and social relationships; self-care, and disturbing and aggressive behaviours.9

References:

1. Summary of Product Characteristics of INVEGA (paliperidone) prolonged-release tablets, May 2007.

2. 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.

3. Davidson M. et al. Efficacy, 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.

4. Kane J, et al. Treatment of schizophrenia with paliperidone extended-release tablets: A 6-week placebo-controlled trial, Schizophrenia Research. 2006: 90; 147-161.

5. 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.

6. Kay SR, et al. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr. Bull 1987:13 (2); 261-276.

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. Morosini P-L, et al. Development, reliability and acceptability of a new version of the DSM-IV social and occupational functioning assessment scale (SOFAS) to assess routine social functioning. Acta Psychiatr. Scand. 2000: 101 (4); 323-329.

A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in intensity or frequency following exposure to the treatments.
Date of Preparation - June 2007 - IBE/07-0038

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