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.
Diagnosis & Disease Information
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.
Key Factors ID’d for Bipolar Medication Nonadherence
Patients report side effects, beliefs, and knowledge about bipolar disorder are top reasons for not taking medications
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.
Lumateperone Under Review for Bipolar Depression
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
Dexmedetomidine Oral Thin Film NDA Submitted for FDA Review
The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I and II studies.
Lumateperone sNDAs Submitted for Bipolar Depression Indication
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
FDA Issues Complete Response Letter for Olanzapine/Samidorphan
While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
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.
Sublingual Dexmedetomidine Promising for Acute Agitation With Schizophrenia, Bipolar Disorder
Dexmedetomidine is currently available as a solution for intravenous infusion for use in clinical anesthesia and sedation in an intensive care setting.
