Drug Watch

The CRL cited several areas for clinical improvement necessary for future approval of the treatment.

Elena Koundourakis, the head of the Orexin Franchise Development and Portfolio Strategy at Takeda, shares her thoughts on the recent positive topline results from a phase 2 trial evaluating TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.

AVP-786, a drug to treat agitation associated with Alzheimer disease dementia, failed to meet the primary efficacy endpoint in a phase 3 clinical trial.

The treatment's PDUFA date is set for August 11, 2024.

Check out this broad range of innovative medications in development with the goal of providing psychiatric clinicians with novel treatments in the quest to decrease patient suffering and improve function and quality of life.

New positive data on TAK-861, an oral orexin receptor 2 agonist, in patients with narcolepsy type 1.

Biogen has officially announced its decision to discontinue all development and sales of aducanumab (Aduhelm) for Alzheimer disease.

The FDA granted clearance for a transcranial magnetic stimulation technology indicated for major depressive disorder and obsessive-compulsive disorder.

The candidate also aims to address neurodevelopmental and neurodegenerative disorders such as Parkinson disease and Rett syndrome.

The results were shared in a poster presentation at the 2024 APSARD Annual Meeting.

Here's an update on which medications are on the horizon for the treatment of schizophrenia and PTSD.

In a first of its kind study, MDMA-assisted therapy successfully supported patients with PTSD.

“If approved, KarXT would represent a new mechanism of action to treat schizophrenia, which would be the first new mechanism potentially in decades.”

New positive pivotal phase 3 study data released on oral weekly risperidone for schizophrenia.

The data assess the extended efficacy of the treatment for up to 4 years.

The device is now available at 2 US clinics, with training and installation currently underway at several other locations.

The device is currently under clinical trial investigation as an adjunct treatment to standard of care therapy for experiential negative symptoms of schizophrenia.

New study results show evenamide as an add-on to antipsychotics for treatment-resistant schizophrenia significantly reduced disease severity.

Initial data from phase 2 safety profile for psilocybin in the treatment of PTSD indicates the treatment is well-tolerated.