Thursday 23 May 2019 ,
Thursday 23 May 2019 ,
Latest News
  • Rooppur ‘graft’: Green City project director withdrawn
  • Eid advance train ticket sale begins
  • Regulatory duty on rice import increased to 25 pc
  • Lack of policy behind paddy price fall: Dr Kamal
  • Number of tigers rises to 114 in Sundarbans
  • Journo's body found in Jamalpur
18 February, 2019 00:00 00 AM

FDA approves Spravato (esketamine) nasal spray for adults with treatment-resistant depression

drugs.com
FDA approves Spravato (esketamine) nasal spray for adults with treatment-resistant depression

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of Spravato (esketamine) nasal spray CIII for adults living with treatment-resistant depression. Spravato is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD).

“We are pleased with the advisory committees’ vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression,” said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. “Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression.”

The committees based their support on the safety and efficacy data from five Phase 3 studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study.

In addition, the Spravato research program provided supportive data from three Phase 2 studies and 19 Phase 1 studies in patients with treatment-resistant depression and healthy volunteers.

Data from both a short-term Phase 3 study and a long-term Phase 3 study demonstrated that esketamine nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms in this difficult-to-treat population.

All the patients who participated in the Phase 3 studies received esketamine or placebo in addition to a newly initiated oral antidepressant at the start of the treatment phase.

The long-term safety study showed that esketamine was generally tolerable, with no new safety signals with dosing up to 52 weeks compared to data from short-term (4-week) studies. Discontinuation rates due to esketamine-related adverse events were low and occurred typically in the first weeks.

Most treatment-emergent adverse events, including dissociative symptoms, dizziness/vertigo, increased blood pressure, and sedation, occurred shortly after dosing while patients were under the supervision of a health care professional, were transient, and resolved the same day. In addition to the comprehensive clinical research program, the company proposed a robust Risk Evaluation and Mitigation Strategy (REMS).

About Spravato

Spravato (esketamine) nasal spray is an investigational product being studied by Janssen Research & Development, LLC as part of a global development program. Esketamine is a glutamate receptor modulator, thought to help restore synaptic connections in brain cells in people with major depressive disorder. It is believed to have a novel mechanism of action, meaning it is thought to work differently than currently available therapies for major depressive disorder.

About treatment-resistant depression

Major depressive disorder affects nearly 300 million people of all ages globally and is the leading cause of disability worldwide. Individuals with depression, including major depressive disorder, experience continuous suffering from a serious, biologically based disease which has a significant negative impact on all aspects of life, including quality of life and function. Although currently available antidepressants are effective for many patients, about one-third of patients do not respond to treatment and are thought to have treatment-resistant depression.

 

Comments

Most Viewed
Digital Edition
More story
From the Editor

From the Editor

Irritable Bowel Syndrome or IBS is a disorder characterised most commonly by cramping, abdominal pain, bloating, constipation and diarrhea. IBS causes…
FAQ on Irritable Bowel Syndrome

FAQ on Irritable Bowel Syndrome

IBS affects between 25 and 45 million Americans. Most of them are women. People are most likely to get the condition in their late teens to early 40s.…
Irritable bowel syndrome (IBS): a long-term gastrointestinal disorder

Irritable bowel syndrome (IBS): a long-term gastrointestinal disorder

CHRISTIAN NORDQVIST Irritable bowel syndrome, or irritable bowel disease, is a long-term gastrointestinal disorder. It causes abdominal pain, bloating,…
Coping with IBS

Coping with IBS

Coping with irritable bowel syndrome (IBS) presents a number of daily challenges. While there is no cure for the disorder, treatments are available. Learn…
12 Foods to avoid with IBS

12 Foods to avoid with IBS

A healthy diet generally consists of eating a wide variety of nutritious foods in moderation. If you have irritable bowel syndrome (IBS), you may notice…
Bowel movement disorders

Bowel movement disorders

Bowel (intestinal) function varies greatly not only from one person to another but also for any one person at different times. It can be affected by diet,…
Type 2 diabetes: losing even a small amount of weight may lower heart disease risk

Type 2 diabetes: losing even a small amount of weight may lower heart disease risk

People with type 2 diabetes are often encouraged to lose weight. And recent studies have shown that losing a lot of weight can reverse diabetes, meaning…
Autism estimates for the USA are wildly inaccurate, say experts at INSAR 2019

Autism estimates for the USA are wildly inaccurate, say experts at INSAR 2019

SALLY ROBERTSON The Centers for Disease Control and Prevention (CDC) has released new statistics on autism. They estimate that there has been a 15% increase…
Biochemical compound responsible for blood pressure drop in sepsis

Biochemical compound responsible for blood pressure drop in sepsis

MARIA FERNANDA ZIEGLER International research group demonstrates the involvement of singlet molecular oxygen in vasodilation, causing a sharp decline…
icddr,b launches artificial intelligence based  diabetic retinopathy detection

icddr,b launches artificial intelligence based diabetic retinopathy detection

Recently, icddr,b in collaboration with Eyes For All PLC, United Arab Emirates and DIAGNOS Inc, Canada have launched an artificial intelligence (AI) based…
Hospitals to test mums-to-be for risky group-B strep

Hospitals to test mums-to-be for risky group-B strep

Screening for a life-threatening bacterial infection affecting newborn babies is to be offered at 80 hospitals in England, Wales and Scotland. About 150,000…
FDA approves Dengvaxia (dengue vaccine) for the prevention of dengue disease in endemic regions

FDA approves Dengvaxia (dengue vaccine) for the prevention of dengue disease in endemic regions

The U.S. Food and Drug Administration announced recently the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused…

Copyright © All right reserved.

Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Disclaimer & Privacy Policy
....................................................
About Us
....................................................
Contact Us
....................................................
Advertisement
....................................................
Subscription

Powered by : Frog Hosting