Janssen reports PALMFlexS trial results of schizophrenia drug Xeplion

1st December 2013 (Last Updated December 1st, 2013 18:30)

Janssen Pharmaceutica has reported encouraging results from the PALMFlexS study, which demonstrated the efficacy, safety and tolerability of Xeplion (paliperidone palmitate) in patients with schizophrenia at various stages of the disease.

Janssen Pharmaceutica has reported encouraging results from the PALMFlexS study, which demonstrated the efficacy, safety and tolerability of Xeplion (paliperidone palmitate) in patients with schizophrenia at various stages of the disease.

The results showed flexible maintenance dosing with Xeplion was associated with a clinically relevant treatment response, and was well tolerated in both acute and non-acute patients with schizophrenia.

The six-month, open-label trial included patients who had previously been unsuccessfully treated with either oral or long-acting antipsychotics.

PALMFlexS is designed to assess the efficacy, safety and tolerability of Xeplion in a population that much more closely resembles day-to-day clinical practice than those included in published pivotal trials, as patients included in the trial had higher rates of comorbidities, substance abuse and/or co-medications.

According to the results, treatment with monthly Xeplion in recently diagnosed non-acute schizophrenia patients (=3 years) gave better clinically relevant responses and lower disease severity, compared with chronic schizophrenia patients (>3 years) at the study endpoint.

"The results showed that monthly treatment with Xeplion provided an early and clinically relevant response as measured by the positive and negative syndrome scale (PANSS) in acutely exacerbated patients with schizophrenia."

Hospital Clínic de Barcelona senior consultant of the Clinic Schizophrenia Programme and investigator in the PALMFlexS study Eduard Parellada said earlier treatment can play a substantial role in improving outcomes in people with schizophrenia, by helping to maintain treatment levels and avoid relapses.

"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," Parellada said.

"This study highlights the value of Xeplion in early treatment but also in maintaining treatment stability at various stages of a patient's disease."

The company said that symptom reduction in both acute and non-acute patients with schizophrenia treated with flexible doses of Xeplion was related with clinically meaningful functional improvements.

The results showed that monthly treatment with Xeplion provided an early and clinically relevant response as measured by the positive and negative syndrome scale (PANSS) in acutely exacerbated patients with schizophrenia.

In addition, 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.

But non-acute patients showed significant improvements in clinical symptoms and functioning when switched to Xeplion, regardless of their previous oral atypical antipsychotic monotherapy.

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.

In addition, the results also demonstrated 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).

According to Parellada, PALMFlexS 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.