• Dainippon Sumitomo Pharma Co. Ltd., of Osaka, Japan, said Latuda (lurasidone HCL) met its key primary and secondary endpoints in two Phase III trials in bipolar I depression. The trials were designed to evaluate safety and efficacy of Latuda as adjunct therapy (PREVAIL 1) and monotherapy (PREVAIL 2). In both studies, patients achieved statistically significant improvements in symptoms of depression, according to the Montgomery-Asberg Depression Rating Scale, compared to placebo.

• Galleon Pharmaceuticals Inc., of Horsham, Pa., said its drug candidate GAL-021 was safe and well tolerated in a Phase I trial in 30 healthy adults. The company is investigating GAL-021 for improving breathing in patients receiving opioids, which are known to depress the respiratory system.

• Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Copenhagen, Denmark, reported that in a Phase III trial in schizophrenia, aripiprazole intramuscular depot formulation significantly delayed time-to-impending relapse compared to placebo. Improvements in symptoms were maintained throughout the study in patients receiving aripiprazole, while patients on placebo worsened. Results were presented at the 2012 American Psychiatric Association Meeting in Philadelphia.

• Pfizer Inc., of New York, said its Pristiq (desvenlafaxine) extended-release tablets (50 mg/day) showed significant increases in time to relapse over six months compared to placebo in a trial in 548 patients with major depressive disorder. The patients had responded to eight weeks of open-label therapy with Pristiq, and remained stable for 12 weeks on treatment. They were randomized to active treatment or placebo for a six-month double-blind study. The data were presented at the 165th Annual Meeting of the American Psychiatric Association in Philadelphia.

• Roche AG, of Basel, Switzerland, reported that following the results of the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial, the independent data and safety monitoring board (DSMB) has recommended stopping the trial due to a lack of efficacy. The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard of care in patients with stable coronary heart disease following an acute coronary syndrome. No safety signals relating to the dal-OUTCOMES trial were reported from the DSMB. Roche said it will terminate the dal-OUTCOMES trial and all the studies in the dal-HEART program.