Alkermes revealed positive results from a phase 4 clinical study of its schizophrenia injectable drug Aristada. Alkermes said on Monday that switching to treatment with Aristada led to improvement in schizophrenia symptoms in patients with inadequate response or intolerance to Invega Sustenna.
“These data further add to the substantial body of evidence supporting the differentiated efficacy and safety profile of ARISTADA in the treatment of this chronic and debilitating disease,” said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “Driven by scientific and economic outcomes data, the recognition of the benefits of long-acting atypical antipsychotics continues to grow within the medical community. Alkermes remains committed to innovating in this disease area where there remains significant unmet medical need and suffering.”
“The results from this study highlight the potential clinical benefits of switching to ARISTADA for patients who experience inadequate response or intolerance to INVEGA SUSTENNA, a medicine widely recognized in the clinical community as a powerful antipsychotic agent,” stated Steven Potkin, M.D., Professor Emeritus of Psychiatry and Human Behavior at theUniversity of California, Irvine. “Patients and their healthcare providers need options with different pharmacology when choosing a treatment regimen, and these data further support the use of ARISTADA in the treatment of schizophrenia.”
Data from the phase 4 study showed that treatment with a flexible dose regimen of ARISTADA 441 mg, 662 mg or 882 mg monthly, or 882 mg every six weeks resulted in significant improvement in schizophrenia symptoms at six months, as measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity (CGI-S) scale. The mean BPRS total score decreased from 37.6 to 32.7 (p=0.002), and the mean CGI-S score decreased from 3.9 to 3.4 (p<0.001) between baseline and the six-month endpoint. Thirty-four patients (68%) completed the six-month study. The most commonly reported adverse events in the study were psychotic disorders, anxiety and suicidal ideation.
“These important data underscore the unique attributes of ARISTADA in the market. With a strong efficacy and safety profile, along with an unmatched range of doses and durations, ARISTADA has the potential to become a market leader in the growing long-acting atypical antipsychotic class,” said Richard Pops, Chief Executive Officer of Alkermes. “We continue to make progress with the ARISTADA launch and look forward to helping patients living with schizophrenia manage their disease with additional flexibility.”
The six-month, open-label, single-arm phase 4 study was designed to assess the efficacy, safety and tolerability of ARISTADA (441 mg, 662 mg, or 882 mg monthly; or 882 mg every six weeks) in 50 symptomatic, clinically stable patients with schizophrenia who had an inadequate response or intolerance to INVEGA SUSTENNA. Efficacy was evaluated in the study based on BPRS and CGI-S scores from commencement of treatment with ARISTADA through the end of the treatment period. Safety and tolerability were evaluated based on reported adverse events.
Patients enrolled in the study had received at least three consecutive doses of INVEGA SUSTENNA prior to screening, with nearly half of the patients entering the study having received the highest dose of INVEGA SUSTENNA 234 mg. The primary reason for discontinuation of INVEGA SUSTENNA was insufficient control of positive symptoms (n=33, 66%). Eight patients (16%) switched due to breakthrough negative symptoms, and nine patients (18%) switched due to intolerance to INVEGA SUSTENNA.