Aripiprazole 2-Month Under Review for Schizophrenia, Bipolar I Disorder
The NDA is supported by data from a phase 1/2 trial that compared the investigational aripiprazole 2-month, long-acting injectable to aripiprazole 1-month depot.
Bipolar Disorders
Spotlight on Pediatric Bipolar Disorder
The main focus of the debate surrounding pediatric bipolar disorder pertains to the concept of a prepubertal subtype of the disorder.
Smartphone Apps Frequently Used for Managing Bipolar Disorder
This study recruited individuals with BD via advertisements on social media and through the Collaborative RESearch Team to study psychosocial issues in Bipolar Disorder (CREST.BD) website and its mailing list.
Igalmi Sublingual Film Approved for Agitation With Schizophrenia, Bipolar Disorder
The approval was based on data from the phase 3 SERENITY I and II studies that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II, respectively.
New Tool May Help Reduce CVD Risk in Patients With Mental Illnesses
A clinical decisions support system provides personalized treatment recommendations on lowering cardiovascular risk factors in patients with schizophrenia, schizoaffective disorder, and bipolar disorder.
Caplyta Approved for Bipolar Depression in Adults
The approval was supported by data from two phase 3 studies that evaluated Caplyta as monotherapy and adjunctive therapy with lithium or valproate in adults with bipolar depression.
Lybalvi Now Available for Schizophrenia, Bipolar I Disorder
Lybalvi is an atypical antipsychotic comprised of samidorphan co-formulated with olanzapine in a single bilayer tablet.
Lybalvi Approved for Schizophrenia, Bipolar I Disorder
The approval was based on data from 27 clinical studies, including the phase 3 ENLIGHTEN-1 and ENLIGHTEN-2 studies.
Dexmedetomidine Oral Film Under Review for Agitation With Schizophrenia, Bipolar Disorder
In both trials, BXCL501 demonstrated statistically significant, rapid and durable improvements vs placebo across multiple agitation scales.
FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
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