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Janssen: Xeplion Effective in Patients with Schizophrenia

New Data Show Efficacy, Safety and Tolerability of Xeplion® in Patients with Schizophrenia at Various Stages of the Disease

PALMFlexS study better reflects Xeplion® use in everyday clinical practice compared to previous clinical trials

BEERSE, Belgium, November 29, 2013

--(BUSINESS WIRE)--

FOR MEDICAL TRADE MEDIA ONLY

Janssen Pharmaceutica NV has announced results of the PALMFlexS study during The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 27-30 November 2013.1-8 Data showed flexible maintenance dosing* with Xeplion® (paliperidone palmitate) was associated with a clinically relevant treatment response, and was well tolerated in both acute and non-acute patients with schizophrenia. Patients in the study had previously been unsuccessfully treated with either oral or long-acting antipsychotics.

PALMFlexS is a prospective 6-month, open-label study investigating the efficacy, safety and tolerability of Xeplion in a population which much more closely resembles day-to-day clinical practice than those included in published pivotal trials,9-11 as patients included in this trial had higher rates of comorbidities, substance abuse and/or co-medications. The data showed that treatment with monthly Xeplion in recently diagnosed non-acute schizophrenia patients (≤3 years) consistently gave greater clinically relevant responses and lower disease severity, compared with chronic schizophrenia patients (˃3 years) at the study endpoint.2

“Earlier treatment can play a substantial role in improving outcomes in people with schizophrenia,12,13 by helping to maintain treatment levels and avoid relapses”, said Dr Eduard Parellada, Hospital Clínic de Barcelona, Senior Consultant of the Clinic Schizophrenia Program and investigator in the PALMFlexS study. “Relapses can have a devastating effect from all perspectives (biological and psychosocial) and it can take a person a long period of time to regain their social functioning, with each successive relapse becoming more difficult to recover from.14 This study highlights the value of Xeplion in early treatment but also in maintaining treatment stability at various stages of a patient’s disease.”

Symptom reduction in both acute and non-acute patients with schizophrenia treated with flexible doses of Xeplion was associated with clinically meaningful functional improvements (as assessed by the Personal and Social Performance (PSP) Scale and Mini-ICF-APP** scores).5

Acute patients with schizophrenia

In acutely exacerbated patients with schizophrenia (n=212), data showed that monthly Xeplion treatment provided an early and clinically relevant response as measured by the positive and negative syndrome scale (PANSS). Two thirds (67%) of patients had ≥30% improvement in the mean PANSS total score, which was a significant improvement from baseline to the last observation carried forward (LOCF) endpoint (p<0.0001).7 A significant reduction in mean PANSS total score was seen as early as day 8.7

Non-acute patients with schizophrenia

A post hoc subgroup analysis of non-acute patients switched from monotherapy with an oral antipsychotic (n=472), showed that Xeplion was associated with significant improvements in PANSS total score from baseline to the LOCF endpoint (p<0.0001). Of all patients switched from previous oral antipsychotics to Xeplion, 74% (risperidone), 58% (paliperidone extended-release), 61% (olanzapine), 66% (quetiapine) and 52% (aripiprazole) had a ≥20% improvement in the PANSS total score from baseline to the LOCF endpoint.3 When switched to Xeplion, non-acute patients showed significant improvements in clinical symptoms and functioning, regardless of their previous oral atypical antipsychotic monotherapy.3

In a post hoc subgroup analysis of non-acute patients switching from long-acting antipsychotics (n=174), use of flexibly-dosed Xeplion significantly improved clinical symptoms and personal and social functioning.5 At LOCF endpoint, 54% (zuclopenthixol decanoate), 55% (haloperidol decanoate), 59% (fluphenazine decanoate) and 62% (flupentixol decanoate) of patients switched to Xeplion had a ≥20% improvement in PANSS total score from baseline.5

The data also showed that clinically relevant responses, improvements in patient functioning, improvements in extrapyramidal symptoms (EPS) and safety and tolerability with monthly Xeplion treatment in non-acute patients were independent of the previous antipsychotic therapy taken by the patient (oral atypical/long-acting treatments).

Significant and clinically relevant improvements in negative and depressive symptoms, disorganised thoughts and importantly, patient relevant outcomes (well-being/patient satisfaction) over six months were seen with Xeplion treatment in non-acute patients switching from oral antipsychotics.4 Effective treatment of negative, disorganised and depressive symptoms is a major unmet need in the treatment of patients with schizophrenia.4

Dr Eduard Parellada, Hospital Clínic de Barcelona, Senior Consultant of the Clinic Schizophrenia Program and investigator in the PALMFlexS study said, “This important study better reflects everyday clinical practice than previous studies and highlights that Xeplion is an important treatment option for patients with schizophrenia at various stages of their illness.”

*Doses between 50-150mg based on the clinical experience of the treating physician

**The Mini-ICF-APP is a shortened version of the International Classification of Functioning, Disability and Health for Mental Disorders (ICF).

*ENDS*

Notes to editor

About the PALMFlexS study

The PALMFlexS study explored the efficacy, safety and tolerability of flexibly dosed Xeplion in the treatment of schizophrenia in patients previously unsuccessfully treated with oral or long-acting antipsychotics.

Patients in the study were split into three study arms: Non-acute patients switching from oral antipsychotics, non-acute patients switching from long-acting injectable antipsychotics and acute patients switching from oral antipsychotics.

Primary outcome measures:

•Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline
•Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline
•Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline
Secondary outcome measures:

•Change from baseline in Clinical Global Impression-Severity Scale [CGI-S]
•Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP])
•Change from baseline in Health status (Self-reported health status questionnaire [SF-36])
•Change from baseline in Measure of Health Outcome (EQ-5D)
•Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S])
Tolerability and safety of Xeplion was evaluated throughout the study.

About schizophrenia

Schizophrenia affects people from all countries, socio-economic groups and cultures. Its prevalence is similar around the world – almost one person in every 100 will develop schizophrenia before they reach the age of 60, with men and women equally at risk.15

There is no single cause of schizophrenia. Different factors acting together are thought to contribute to the development of the illness. Both genetic and environmental factors seem to be important.16 The symptoms of schizophrenia can include hallucinations, delusions, lack of emotional response, social withdrawal/depression, apathy and a lack of drive or initiative.

While schizophrenia is a lifelong condition, there are treatments available that allow people with schizophrenia to get better. Clinical guidelines recommend that for people with schizophrenia the optimal treatment package is a combination of medication along with psychotherapy, psycho-education and self-help.17 Beyond simply controlling symptoms, effective treatment may allow people with the condition to enjoy a more fulfilling life, which may include returning to work or study, independent living and social relationships.

For more information about schizophrenia, as well as helpful resources and interactive tools for those affected by the condition, visit www.schizophrenia24x7.com. This site is sponsored by Janssen Pharmaceutica NV.

About Janssen

Janssen Pharmaceutica NV and its worldwide group of pharmaceutical companies are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-emea.com

References

1. Bergmans P et al. Paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with aripiprazole. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P002 (Session P-06).

2. Hargarter L et al. Once monthly paliperidone palmitate – Tolerability and treatment response in recently diagnosed versus chronic non-acute schizophrenia patients switched from previously unsuccessful treatment with oral antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P003 (Session P-07).

3. Hargarter L et al. Flexibly dosed paliperidone palmitate in non-acute patients with schizophrenia switched from previously unsuccessful monotherapy with oral atypical antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P002 (Session P-07).

4. Schreiner A et al. Paliperidone palmitate – Impact on negative, disorganized and depressive symptoms, subjective well-being and patient satisfaction in patients with schizophrenia previously unsuccessfully treated with oral antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P006 (Session P-08).

5. Schreiner A et al. Flexibly dosed paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with conventional depot antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P007 (Session P-08).

6. Bergmans P et al. Flexibly dosed paliperidone palmitate in non-acute but symptomatic patients with schizophrenia previously unsuccessfully treated with long-acting injectable risperidone. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P003 (Session P-06).

7. Cherubin P et al. Paliperidone palmitate in acute patients with schizophrenia – Treatment response, safety and tolerability: A prospective flexible dose study in patients previously unsuccessfully treated with oral antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P007 (Session P-06).

8. Cherubin P et al. Functional outcomes with once monthly paliperidone palmitate in acute and in non-acute patients with schizophrenia: Data from a prospective flexible dose study in patients with schizophrenia previously unsuccessfully treated with oral antipsychotics. Poster presented at The German Society for Psychiatry and Psychotherapy, Psychosomatic Medicine and Neurology (DGPPN) congress in Berlin, 26-30 November 2013. Poster P006 (Session P-06).

9. Gopal S et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010;25:247–256

10. Nasrallah H et al. A Controlled, Evidence-Based Trial of Paliperidone Palmitate, A Long-Acting Injectable Antipsychotic, in Schizophrenia. Neuropsychopharmacology 2010;35:2072–2082

11. Pandina GJ et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30:235–244

12. Emsley R. et al. Long-acting injectable antipsychotics in early psychosis: a literature review. Early Interv Psychiatry. 2013 Aug;7(3):247-54

13. Parellada E et al. Long-Acting Injectable Antipsychotics in First-Episode Schizophrenia. Schizophrenia Research and Treatment 2012; 318535.

14. Hough D et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled study. Schizophrenia Research 2010;116:107–117

15. American Psychiatric Association (APA). Practice guideline for the treatment of patients with schizophrenia. Second edition 2004;42

16. Lang et al. Molecular mechanisms of schizophrenia. Cellular Physiology and Biochemistry 2007;20:687

17. National Institute for Clinical Excellence: Schizophrenia: The NICE guideline on core interventions in the treatment and management of schizophrenia in primary and secondary care; National Clinical Practice Guidelines Number CG82, available at www.nice.org.uk/nicemedia/live/11786/43607/43607.pdf Last accessed October 2013

Contacts
For further information please contact:
Janssen
Laura Dobell
Phone: +44 (0)1494 658 151
Email: ldobell@its.jnj.com
or
Publicis Life Brands Resolute
Joanna Sullivan
Phone: +44 (0) 207 3977 485
Email: joanna.sullivan@publicislifebrandsresolute.com
 

Posted: December 2013


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