Esketamine

Houston based depression psychiatrist, Dr. Sandhya Prashad, M.D., tells how this new drug might save lives and cost less than expected

Retrieved on: 
onsdag, mars 6, 2019

HOUSTON, March 5, 2019 /PRNewswire/ -- "New FDA approved depression treatment, esketamine, is the biggest advancement in depression treatment in thirty years" says Houston based Psychiatrist, Dr. Sandhya Prashad.

Key Points: 
  • HOUSTON, March 5, 2019 /PRNewswire/ -- "New FDA approved depression treatment, esketamine, is the biggest advancement in depression treatment in thirty years" says Houston based Psychiatrist, Dr. Sandhya Prashad.
  • Ketamine has been hailed as the most important advancement in the treatment of depression in the past 50 years.
  • Ketamine works on the NMDA receptor and modulates glutamate instead of serotonin, norepinephrine, and dopamine like traditional antidepressants.
  • Dr. Sandhya Prashad, board certified Psychiatrist based in Houston, has specialized in treatment resistant depression and has been using ketamine in her practice since 2016.

Imminent FDA Approval of Addictive Ketamine for Depression Brings Back Echoes from the Opiate Epidemic

Retrieved on: 
måndag, mars 4, 2019

WEST ORANGE, N.J., March 4, 2019 /PRNewswire/ -- FDA's approval of ketamine to address depression classified as 'treatment resistant' is a double-edged sword.

Key Points: 
  • WEST ORANGE, N.J., March 4, 2019 /PRNewswire/ -- FDA's approval of ketamine to address depression classified as 'treatment resistant' is a double-edged sword.
  • "It is welcome news for millions of patients suffering from untreated depression who could now find relief," said Dr. Cidambi.
  • FDA-approved ketamine, or esketamine, is low-dose (28mg nasal spray) and well below the threshold for delivering a high.
  • The FDA recommends that patients try 2 traditional antidepressants before their depression can be classified as 'treatment resistant.'

Brain & Behavior Research Foundation Applauds FDA Expert Panel Decision to Recommend Approval of New Depression Treatment

Retrieved on: 
torsdag, februari 14, 2019

NEW YORK, Feb. 14, 2019 /PRNewswire/ --The Brain & Behavior Research Foundation (BBRF) is pleased that our funding of both early research and ongoing studies on rapid acting antidepressants has helped lead to the development of a new medication for treatment resistant depression.

Key Points: 
  • NEW YORK, Feb. 14, 2019 /PRNewswire/ --The Brain & Behavior Research Foundation (BBRF) is pleased that our funding of both early research and ongoing studies on rapid acting antidepressants has helped lead to the development of a new medication for treatment resistant depression.
  • "The FDA panel's recommendation of Esketamine as a new medication for treatment resistant depression is welcome news for people and their families who are impacted by depression," said Dr. Jeffrey Borenstein, President & CEO of BBRF.
  • Since 1996, BBRF has awarded 90 grants totaling more than $6.5 million to fund research on rapid acting antidepressants conducted by scientists in the United States and abroad.
  • The Brain & Behavior Research Foundation awards research grants to develop improved treatments, cures, and methods of prevention for mental illness.

FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

Retrieved on: 
tisdag, februari 12, 2019

"Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."

Key Points: 
  • "Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression."
  • SPRAVATOTM (esketamine) nasal spray is an investigational product being studied by Janssen Research & Development, LLC as part of a global development program.
  • Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression.
  • A Randomized Withdrawal, Double-blind, Multicenter Study of Esketamine Nasal Spray Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression.

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression

Retrieved on: 
tisdag, september 4, 2018

TITUSVILLE, N.J., Sept. 4, 2018 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray.

Key Points: 
  • TITUSVILLE, N.J., Sept. 4, 2018 /PRNewswire/ --The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray.
  • Esketamine nasal spray will be self-administered by patients under the supervision of health care professionals.
  • Janssen plans to submit a Marketing Authorization Application (MAA)to the European Medicines Agency (EMA) for the esketamine treatment-resistant depression indication later in 2018.
  • A Randomized Withdrawal, Double-blind, Multicenter Study of Esketamine Nasal Spray Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression.

Janssen to Present Data in Treatment-Resistant Depression, Schizophrenia, Health Economics and Outcomes and Population Health at American Psychiatric Association 2018 Meeting

Retrieved on: 
torsdag, maj 3, 2018

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

Key Points: 
  • At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
  • Esketamine nasal spray is an investigational compound being studied by Janssen Research & Development, LLC as part of a global development program.
  • INVEGA TRINZA is used in people who have been treated with INVEGA SUSTENNA (1-month paliperidone palmitate) for at least 4 months.
  • INVEGA SUSTENNA (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional.