Drug Watch

Newly shared top-line phase 4 data demonstrates clinically meaningful and sustained effects of Ingrezza capsules on the physical, social, and emotional impacts experienced with tardive dyskinesia.

The FDA has accepted the supplemental New Drug Application for Uzedy extended-release injectable suspension for the maintenance treatment of bipolar I disorder in adults.

Determining risks outweigh the benefits, the FDA is removing the clozapine REMS requirement.

The FDA gave positive feedback to Adial Pharmaceuticals regarding its proposed in vitro bridging strategy for the phase 3 formulation of AD04.

The FDA has authorized key modifications to the administration protocol for injectable long-acting opioid use disorder treatment buprenorphine.

After a lot of recent positive news for SPN-820, a recent phase 2b study shows the novel antidepressant failed to demonstrate a statistically significant improvement on the primary endpoint of change from baseline.

What are the top 6 disappointing psychopharmacological updates from the past year? We rank the top 6.

Recent research demonstrated that xanomeline-trospium is more efficacious than placebo in treating positive and negative psychotic symptoms in adults with schizophrenia.

A new patent was issued for Adial Pharmaceuticals’ identification of patients with specific genetic markers linked to substance use disorders and treatment with AD04.

New phase 3 data on CYB003 is coming. Learn more about the phase 3 pivotal program here.

In mice models, opioid delta-receptor agonists showed promise in helping to relieve abdominal pain and regulate bowel movements. Is targeting the brain the best path forward for IBS treatment?

Check out the pipeline updates from January!

New positive results of a pharmacokinetics study of AD04 for alcohol use disorder confirms the near micro-dosing regimen planned for upcoming trials.

Check out new positive topline results from the open-label phase 2A study of BPL-003 in participants with moderate-to-severe alcohol use disorder.

Neurocrine is initiating a phase 3 study of osavampator for the treatment of adults with major depressive disorder.

The FDA has approved the supplemental New Drug Application for Spravato, the first and only monotherapy for adults with treatment-resistant depression.

The lates update in lecanemab’s journey: the FDA has accepted the BLA for lecanemab-irmb subcutaneous autoinjector for weekly maintenance dosing.

The FDA grants Breakthrough Device Designation to Spear Bio’s pTau 217 blood test for Alzheimer disease.

Johnson & Johnson today announced that they will acquire all outstanding shares of Intra-Cellular Therapies, as well as their therapeutic pipeline, including lumateperone.

The FDA has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody being investigated for the treatment of patients with early Alzheimer disease.

Check out the positive topline results from a phase 2 dose finding trial evaluating N-methyl amisulpride (LB-102) in adult patients with acute schizophrenia.

Navacaprant for the treatment of major depressive disorder has failed in the phase 3 KOASTAL-1 trial.

New positive topline results from an open-label phase 2a study of IV psilocin benzoate in patients with major depressive disorder showed that the treatment delivers rapid, lasting antidepressant effects for up to 3 months following a single dose.

Data presented at ACNP meeting demonstrated safety, tolerability, and efficacy for SPN-820 for MDD.

Check out 2 new psychopharmacology innovations!

Intra-Cellular Therapies has submitted an sNDA for lumateperone for the treatment of major depressive disorder in adults as adjunctive therapy to antidepressants.

In the phase 3 ENCORE trial, AXS-12 reduced the frequency of cataplexy attacks as compared with placebo at week 3 of the double-blind period.

Calling it a barrier to care, FDA committees decide to end clozapine REMS.

How is the study of muscarinic receptors transforming schizophrenia treatment?

Check out new results of a pharmacokinetics study of AD04, an investigational therapeutic agent for the treatment of alcohol use disorder in patients with heavy drinking.