Drug Watch

Why are experts excited about KarXT, a novel muscarinic acetylcholine receptor agonist that, if approved, is poised to revolutionize schizophrenia treatment?

The PDUFA date for KarXT for schizophrenia is September 26, 2024. Here’s what one expert thinks of this potential treatment.

DaylightRx becomes the very first FDA-cleared digital treatment for generalized anxiety disorder.

Abbott has initiated the TRANSCEND study to evaluate the use of deep brain stimulation to manage treatment-resistant depression.

Phase 2 trials suggest extended-release oral ketamine formulations could be alternative to clinic-administered treatment for resistant depression.

The first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia sees positive phase 2 results in the lowest tested dose.

Esmethadone missed primary efficacy measure in phase 3 clinical trial after robust results in phase 2, possibly more to differences in the cohorts than the compound.

New phase 1b results of VLS-01, an oral transmucosal film formulation of DMT, show ‘psychologically meaningful’ improvement for patients with treatment-resistant depression.

Write to us now to be part of our series on treatment updates this month.

Check out these exciting updates from the recent RISE study on TV-46000, a subcutaneous long-acting injectable antipsychotic formulation of risperidone.

The US Food and Drug Administration has approved Erzofri, a paliperidone palmitate extended-release injectable suspension for the treatment of adults with schizophrenia and schizoaffective disorder.

A supplemental New Drug Application has been submitted to the FDA seeking approval of esketamine (Spravato) CIII nasal spray as a monotherapy for adults with treatment-resistant depression.

The FDA has issued a complete response letter to Orexo for OX124, a high-dose naloxone nasal spray for opioid overdose reversal.

Kisunla (donanemab-azbt) is now approved by the FDA for adults with early symptomatic Alzheimer disease.

While ketamine is a not approved for the treatment of depression or chronic pain, clinicians have shown increased interest in using it for these conditions. An FDA workshop is exploring its potential.

June held negative news for psychedelics and an accepted sNDA for brexpiprazole + sertraline for adults with PTSD.

The FDA has approved its supplemental New Drug Application for Wakix tablets for the treatment of excessive daytime sleepiness in pediatric patients aged 6 years and older with narcolepsy.

The FDA has authorized the marketing of 4 menthol-flavored e-cigarette products in the United States through the premarket tobacco product application pathway.

ALTO-101 has previously been shown to positively impact cognition in schizophrenia.

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints, according to new study.

Following the vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee, Lykos has released a statement on MDMA-assisted therapy.

The FDA Advisory Committee recommended donanemab, which could lead to its approval later this year.