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.
Schizophrenia
Invega Hafyera Approved for Twice-Yearly Treatment of Schizophrenia
The Food and Drug Administration has approved Invega Hafyera™ (paliperidone palmitate), an every 6-month injection, for the treatment of schizophrenia in adults. Invega Hafyera is a long-acting atypical antipsychotic that is administered as a gluteal intramuscular injection by a health care professional. Prior to initiating treatment with Invega Hafyera, patients must have been adequately treated…
Application for Long-Acting Schizophrenia Treatment Accepted for Review
Patients treated with the investigational subcutaneous risperidone injection experienced a statistically significant delay in the time to relapse.
MPR Weekly Dose Podcast Episode 88
The FDA authorizes a postexposure prophylaxis for COVID-19; A new treatment is okay’d for lupus; A higher dose naloxone nasal spray became available; The risk evaluation and mitigation program for Clozapine has had important changes, and finally, Istodax has had an indication withdrawn.
Important Clozapine REMS Program Changes Announced
According to the FDA, prescribers and pharmacies must be re-certified in the Clozapine REMS program by November 15, 2021 to continue to prescribe or dispense clozapine.
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.
Novel Glycine Transporter Inhibitor Gets Breakthrough Tx Status for Cognitive Impairment With Schizophrenia
The designation is based on results from a phase 2 trial that evaluated the efficacy and safety of 4 different doses of BI 425809 orally once daily in adults with CIAS for 12 weeks.
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.
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.
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.
