bodyType

customContents

entityId

entityUuid

articlePageQuery

filter

article

articleBaseAdvertisingInfoArticle

articleListArticle

articleSeoArticle

helpersCheckIsPostiesArticle

hooksArticleAcknowledgementGateOverlayArticle

hooksTrackPageViewArticle

hooksContentInterestArticle

articleLinkingDataContent

articleSchemaContent

liveArticle

advertZone

sentiment

contentLock

topics

types

sections

moreOnThisArticles

urlAlias

commentCount

authorLocations

authors

paywallTypes

corrections

sponsorType

displaySlideShow

multimediaEmbed

printHeadline

seriesContainer

socialHeadline

headline

flag

firstTopic

glossary

flattenTypeIds

publishedDate

additionalInfoBoxes

images

image

relatedLinks

relatedNewsletters

__typename

createdDate

sponsor

factSheets

seriesReverseOrder

series

disableOffPlatformContent

published

updatedDate

summary

subHeadline

body

keywords

copyrighted

customTimezone

liveContents

Agence France-Presse

US regulators have approved the sale of a new drug that could revolutionise the treatment of severe depression, giving new hope to sufferers who have not found an effective option.
The Food and Drug Administration (FDA) followed the recommendation of an expert panel and approved esketamine nasal spray, marketed under the brand name Spravato, by Johnson & Johnson’s pharmaceutical unit Janssen.
FDA approval provides the first new mechanism in 30 years “to treat this debilitating mental illness,” Janssen said in a statement.
The drug, designed for those who have tried at least two other medications, offers “a potential therapy for adults living with treatment-resistant depression,” the company said, including help in combating suicidal thoughts.
Depression among fathers and their daughters is linked, study finds, amid new concern about postnatal mental health of men
Pierre de Maricourt of the Sainte-Anne Hospital in Paris, participating in two phase 3 trials for the drug, hailed the approval as “major evolution in the treatment of depression”.
He emphasised the “significant effectiveness and speed of action” of esketamine, “in a few days, when it takes six to eight weeks for a conventional antidepressant.”
Maricourt said the treatment would have to be administered at a medical facility to monitor the patient.

But others were concerned about overhyping the drug, and worried about approving it too quickly.
Kim Witczak, a consumer member of the FDA advisory panel, who voted against approval, cautioned that the rush to get the drug to market meant testing may have been insufficient.
The “disease label of ‘Treatment Resistant Depression’ (TRD) is also the new buzzword allowing drug companies to obtain FDA fast tracking or ‘breakthrough therapy’ designation without having to go through more rigorous testing protocols,” Witczak said in recent a blog post.
The FDA applied restricted distribution (REMS) to the drug, including mandating that it only be administered under medical supervision and monitoring.
One in three young Hongkongers suffers from stress, anxiety or depression, Hong Kong Playground Association survey shows
It said the restrictions were necessary “because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug.”
However, Witczak said the REMS “are not enforceable and the drug companies are responsible for managing and reporting to the FDA.”
Janssen said the FDA relied on five studies showing the nasal spray worked more quickly than many currently marketed antidepressants, which sometimes take several weeks to have an effect.
Esketamine is related to ketamine, which is used as an anaesthetic in humans and animals but also as a narcotic.
The ketamine-like drug is the first of several psychoactive substances making their way through the US regulatory process as physicians search further afield for new therapies.
Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder.
Mental health in the workplace, and why Hong Kong lags behind in its support of staff
Janssen applied for authorisation for Spravato from the European Medicines Agency (EMA) in October.
According to the World Health Organisation, some 300 million people around the world suffer from depression, a disease that severely limits the ability to lead a normal daily life and can in the most severe cases lead to suicide, and Janssen said a third of sufferers do not respond to existing treatments.
The UN agency said each year nearly 800,000 people die by suicide, which is the second leading cause of death among 15-29 year olds worldwide.
Robin Prothro, 60, began taking antidepressants more than 20 years ago. But she says none of the five medications she tried relieved the depression that has stymied her personal and professional life.
Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she’s returned to hobbies she abandoned years ago, like gardening.
She takes the drug every two weeks at her psychiatrist’s office while reclining in a comfortable chair.
“You can feel it coming on, it’s a strong drug,” she said, describing colours and shapes that drift before her eyes.
“I just let the drug work. I close my eyes and my mind is amazingly quiet.”
Additional reporting by Associated Press and Bloomberg


What is AMD? Eye condition could cause blindness – and only an eye test can detect it

Genetic links to depression found in big global study, giving hope for new treatments

Does castor oil improve health? It’s a social media hit and was used by Cleopatra

Remote-controlled Bluetooth sex toys can be hacked by third parties, research shows

Wellness

FDA approves Spravato, a fast-acting, Ketamine-like nasal spray to treat people with severe depression

Spravato a mind-altering medication related to the club drug Special K, won US approval. Photo: AP

Your work schedule could put you at risk for depression, study say. (Dreamstime/TNS)

News

World

United States & Canada

The spray acts within hours, rather than weeks or months as is typical for current antidepressants
According to the World Health Organisation, some 300 million people around the world suffer from depression


The spray acts within hours, rather than weeks or months as is typical for current antidepressants.


Medicine

FDA approves Spravato, a fast-acting, Ketamine-like nasal spray to treat people with severe depression

The spray acts within hours, rather than weeks or months as is typical for current antidepressants According to the World Health Organisation, some 300 million people around the world suffer from depression

The spray acts within hours, rather than weeks or months as is typical for current antidepressants

According to the World Health Organisation, some 300 million people around the world suffer from depression