The US Food and Drug Administration (FDA) on Tuesday said that it approved a Johnson & Johnson nasal spray anti-depressant for people resistant to other treatments, but placed restrictions on use of the drug, which it warned could be misused and abused.
The approval of esketamine marks the first new type of treatment for depression in more than 30 years and has raised hopes for its relatively fast action and ability to treat some otherwise unreachable patients.
Esketamine would be sold under the brand name Spravato and is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational party drug and goes by the street nickname “Special K.”
To prevent abuse, the drug must be administered to patients in a doctor’s office or medical facility and cannot be taken home.
Other anti-depressants, such as Eli Lilly and Co’s Prozac, work on neurotransmitters like serotonin and norepinephrine, but most drugs take at least four weeks to show effect and fail to produce an adequate response in about 30 to 40 percent of patients with major depressive disorder.
“Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies,” said Mathai Mammen, global head of Johnson & Johnson’s Janssen Research and Development unit.
Spravato has been touted as an asset with blockbuster potential and is expected to improve investor sentiment toward the growth prospects of pharma unit Janssen, as its top-selling rheumatoid arthritis drug Remicade faces increased competition from cheaper biosimilars.
The treatment carries a boxed warning — the FDA’s harshest — flagging the risk for sedation and difficulty with attention, judgement and thinking; abuse and misuse; and suicidal thoughts after administration of the drug.
Spravato is absorbed by the lining of the nasal passages and into the blood stream and is to be used along with a newly prescribed oral anti-depressant, Johnson & Johnson said in a statement.
During clinical trials, Spravato was found to relieve depression symptoms within 24 hours in some patients, Janssen spokesman Greg Panico said.
The approval comes after an FDA advisory panel last month voted heavily in favor of esketamine, saying that its benefits outweighed the risks.
However, the panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in a study.
The drug is also being tested in patients with depression who are at a high risk of committing suicide.
Research has shown that depression involves deterioration of the quality and number of nerve cell connections in areas of the brain related to mood.
Esketamine helps restore these nerve cell connections in the brain, leading to an improvement in depression symptoms, the company said.
More than 300 million people globally live with major depressive disorders, and the incidence of attempted suicide in people with the condition is about 20-fold greater than that among those without the disorder.
Stephen Garrett, a 27-year-old graduate student, always thought he would study in China, but first the country’s restrictive COVID-19 policies made it nearly impossible and now he has other concerns. The cost is one deterrent, but Garrett is more worried about restrictions on academic freedom and the personal risk of being stranded in China. He is not alone. Only about 700 American students are studying at Chinese universities, down from a peak of nearly 25,000 a decade ago, while there are nearly 300,000 Chinese students at US schools. Some young Americans are discouraged from investing their time in China by what they see
MAJOR DROP: CEO Tim Cook, who is visiting Hanoi, pledged the firm was committed to Vietnam after its smartphone shipments declined 9.6% annually in the first quarter Apple Inc yesterday said it would increase spending on suppliers in Vietnam, a key production hub, as CEO Tim Cook arrived in the country for a two-day visit. The iPhone maker announced the news in a statement on its Web site, but gave no details of how much it would spend or where the money would go. Cook is expected to meet programmers, content creators and students during his visit, online newspaper VnExpress reported. The visit comes as US President Joe Biden’s administration seeks to ramp up Vietnam’s role in the global tech supply chain to reduce the US’ dependence on China. Images on
New apartments in Taiwan’s major cities are getting smaller, while old apartments are increasingly occupied by older people, many of whom live alone, government data showed. The phenomenon has to do with sharpening unaffordable property prices and an aging population, property brokers said. Apartments with one bedroom that are two years old or older have gained a noticeable presence in the nation’s six special municipalities as well as Hsinchu county and city in the past five years, Evertrust Rehouse Co (永慶房產集團) found, citing data from the government’s real-price transaction platform. In Taipei, apartments with one bedroom accounted for 19 percent of deals last
US CONSCULTANT: The US Department of Commerce’s Ursula Burns is a rarely seen US government consultant to be put forward to sit on the board, nominated as an independent director Taiwan Semiconductor Manufacturing Co (TSMC, 台積電), the world’s largest contract chipmaker, yesterday nominated 10 candidates for its new board of directors, including Ursula Burns from the US Department of Commerce. It is rare that TSMC has nominated a US government consultant to sit on its board. Burns was nominated as one of seven independent directors. She is vice chair of the department’s Advisory Council on Supply Chain Competitiveness. Burns is to stand for election at TSMC’s annual shareholders’ meeting on June 4 along with the rest of the candidates. TSMC chairman Mark Liu (劉德音) was not on the list after in December last