Intro speaker— Dr. Sokolowska
FDA does not regulate the practice of medicine.
Esketamine was approved in 2019 as a nasal spray for treatment resistant depression in conjunction with an oral antidepressant, and in 2020, was approved for suicidality.
The FDA has not approved ketamine for other mental health indications, nor pain conditions, and does not approve compounded medicines.
The FDA issued 2 risk alerts on compounded ketamine products.
In spite of this, the FDA recognizes the real-world use and ongoing study of ketamine in a variety of formulations.
Today’s meeting goals - expand knowledge, knowledge gaps, safety issues
Sanacora from Yale (affiliated with Johnson & Johnson and has several financial disclosures / conflict of interests as he profits from people being prescribed Jansen’s esketamine branded Spravato).
History of ketamine - lists first study on antidepressant efficacy in 1990. (Inaccurate)
Mechanism of action - neural plasticity & NMDA receptors (circa 1990) - suggested depression was more of a cortical disorder
Found ketamine can have rapid, lasting antidepressant activity (notes small studies with small sample sizes) 2016 studies
Alleges very little clinical evidence, with evidence on neurotoxicity and brain lesions, unaware of the wealth of data at the time, yet was part of the American Psychiatric Association’s position statement on ketamine in psychiatric use in 2017.
Who will do multi-million dollar studies? Someone came up with the idea of using esketamine, half of what’s in normal racemic ketamine.
Esketamine, more potent at NMDA receptor. Jansen pharmaceucticals sponsored the studies required by the FDA, which approved the medicine in 2019. Data over 58,000 patients with 800,000 administrations of esketamine.
Compares to ketamine study of 195 people from 2019, does mention Osmind study, alleging community using higher doses
Rapidly shifting landscape, mentions recent oral and iv ketamine studies, alleging poor scientific rigor.
Make treatment available, but balancing with safety.
A more complete discussion on Sanacora later.