Date: 02-Dec-2019

Acadia's Nuplazid rebounds in schizophrenia with study win

Acadia's Nuplazid suffered a big loss in July after a late-stage trial as an add-on treatment for schizophrenia fell flat. But that study wasn't Nuplazid's last go at the indication, and now a phase 2 win could help Acadia get over the top. Nuplazid added to standard-of-care antipsychotics bested antipsychotics alone in reducing the negative symptoms of schizophrenia after 26 weeks in patients with controlled positive symptoms, according to top-line data from Acadia's phase 2 Advance study. Acadia said it would launch a second pivotal study for the 34-milligram dose of Nuplazid in the first half of 2020, with additional results from the Advance study set to be presented at a future medical meeting. The positive efficacy results and favorable tolerability profile of (Nuplazid) observed in the Advance study represent an important step forward for patients and their families, given the lack of currently approved treatment options for the negative symptoms of schizophrenia,” Acadia President Serge Stankovic said in a release. RELATED: Acadia's Nuplazid flops schizophrenia trial on the heels of DOJ marketing probe The Advance study tested patients on the Negative Symptom Assessment-16 total score, with symptoms including social withdrawal, apathy, anhedonia, loss of motivation, blunted affect, and restricted speech, Acadia said. Patients in the Nuplazid arm were started on a 20-milligram dose of the drug and could have been placed on a higher, lower or same dosing during the first eight weeks of treatment. At 26 weeks, 53.8% of patients were treated with the 34-milligram dose, compared with 44.7% on the 20-milligram dose and 1.5% on the 10-milligram dose. Patients treated with the 34-milligram dose showed a greater improvement in symptoms than those treated with other doses.On the secondary endpoint––improvement on the Personal and Social Performance scale––Nuplazid showed no significant difference over antipsychotics alone. Analysts expressed cautious optimism over the data, nothing that Acadia's planned second trial could take years to back up those results. That trial will likely last between two and two-and-a-half years, SVB Leerink analyst Marc Goodman wrote in a note to clients. That timeframe led the firm to push back its potential launch date for Nuplazid in schizophrenia to 2023.