Shots: The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio (2:1) aged 18-70yrs. with schizophrenia […]readmore
Tags : Schizophrenia
Shots: The BTD is based on P-II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia Moreover, the company has initiated the P-III CONNEX […]readmore
Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment of agitation associated with schizophrenia […]readmore
Shots: The P-II study involves assessing of BI 425809 (4 oral doses, qd) vs PBO over 12wks. treatment period in schizophrenia patients. The results are presented at the 33rd ECNP […]readmore
Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu […]readmore
Shots: Saniona to receive up to $84.6 as milestones along with royalties on sales of the therapies. Boehringer Ingelheim to get an exclusive global right to research, develop, manufacture and […]readmore
Shots: The NDA is based on ENLIGHTEN-1 & 2 studies assessing the antipsychotic efficacy & weight gain with ALKS 3831 (olanzapine/samidorphan) vs PBO & Zyprexa (olanzapine) for 4 & 6wks. […]readmore
Shots: The approval is based on the study assessing CAPLYTA (42 mg) vs PBO while keeping Positive and Negative Syndrome Scale (PANSS) as 1EP The study resulted in somnolence/sedation (24% […]readmore
Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study results: PANSS @6weeks (-19.3 vs -12.7); AEs […]readmore
Shots: The P-III JEWEL Study involves assessing lurasidone (40 mg/day) vs PBO @6wks. in 483 patients with Schizophrenia, conducted for regulatory approval in Japan The P-III JEWEL Study results demonstrated […]readmore