New Schizophrenia Drug Extends Time to Relapse and Treatment Discontinuation

The results of a new clinical trial from Schering-Plough of the schizophrenia drug Saphris (asenapine) has shown that the drug is effective at significantly extending both the time to relapse or impending relapse and the time to treatment discontinuation.

According to the researchers, time to relapse or impending relapse “was significantly longer with Saphris than with placebo.” In addition, at the end of the double-blind phase of the study, “significantly fewer patients had relapsed with Saphris than with placebo, 12 percent vs. 47 percent."

This set of factors about relapse in patients was the primary endpoint of the study and was defined, according to the researchers, “as one of the following: 1) a PANSS (Positive and Negative Syndrome Scale) total score increase of equal to or greater than 20 percent from baseline in the double-blind phase and a CGI-S (Clinical Global Impression-Severity of Illness) score of equal to or greater than 4 at least two days within one week; 2) a PANSS score equal to or greater than 5 on 'hostility' or 'uncooperativeness' items or on 'unusual thought content,' 'conceptual disorganization' or 'hallucinatory behavior' items, and a CGI-S score equal to or greater than 4 (at least two days within one week); or 3) the investigator's judgment of worsening symptoms or increased risk of violence to self (including suicide) or others."

In terms of side affects, the researchers noted that treatment-emergent and treatment-related adverse events were higher as a result of placebo than of Saphris. The most commonly reported adverse events included "anxiety (8.2 percent with SAPHRIS vs. 10.9 percent with placebo), increased weight (6.7 percent with SAPHRIS vs. 3.6 percent with placebo) and insomnia (6.2 percent with SAPHRIS vs. 13.5 percent with placebo)." Schizophrenia that worsened during the course of the study was reported by 4.6% of SAPHRIS-treated patients and 16.1% of placebo-treated patients.