The effects were found to be significantly better than placebo and comparable to that of an approved atypical antipsychotic agent. No serious adverse events attributable to ocaperidone were seen and patients experienced significantly less weight gain with ocaperidone than with the reference compound.
The phase II studies consisted of two international randomized clinical trials, OCA-05 and OCA-06. In both studies, large improvements from baseline were seen in all primary efficacy measures. Significant improvements were observed in all PANSS subscores in the ocaperidone-treated group compared to placebo and a large improvement in BPRS and CGI scores versus baseline was observed.
No change in mean weight gain was seen in patients receiving ocaperidone in the placebo-controlled trial, OCA-05. In the OCA-6 study weight gain was statistically significant higher in patients treated with the reference compound. Furthermore, there were no serious adverse effects and no cardiovascular events observed with ocaperidone.
“By demonstrating superior efficacy over placebo and comparable efficacy to a well established antipsychotic, but with a good side effect profile, in particular less weight gain, ocaperidone fulfilled our expectations based on our earlier results,” noted Charles Woler, CEO of Neuro3d. “These data will form the basis of larger scale, phase III trials, where the effects of ocaperidone can be evaluated further.”