techkenyot.com
techkenyot.com March 20, 2019


FDA Approves Fast-Acting Nasal Inhaler Depression Drug

12 March 2019, 05:54 | Silvia Roy

FDA approves new Johnson & Johnson drug for depression

Ketamine-based drug approved for treating severe depression in the US

The drug is made by Johnson & Johnson and is marketed under the name Spravato.

The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants. It is the first new antidepressant to be approved in decades that works in an entirely novel way, the first antidepressant to come in nasal spray form, and the first to work in a very short time rather than in weeks or even months. In all three, patients were started on a new oral antidepressant and randomized to receive Spravato or placebo in addition - a design that experts on the advisory committee indicated better reflected how the drug would be used in the real world.

"There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Dr. Tiffany Farchione, acting director of the FDA's Division of Psychiatry Products.

Marquese Chriss and Serge Ibaka Exchange Punches in Nasty Fight
While the Raptors have won two straight, the Cavaliers have lost two straight, most recently a 126-110 loss to the Heat in Miami. G Patrick McCaw made his first start with the team Sunday at Miami with Leonard sidelined, scoring 10 points in 26 minutes.

A mind-altering medication related to the club drug Special K won USA approval Tuesday for patients with hard-to-treat depression, the first in a series of long-overlooked substances being reconsidered for severe forms of mental illness. It has been slated to cost around $885 (£673) per treatment. For Spravato, however, the agency agreed to consider a withdrawal, or maintenance, study as one of the two positive trials supporting J&J's application.

The FDA concludes the drug is also being tested in patients with depression who are at a high risk of committing suicide.

The nasal spray must be taken by patients under the supervision of a healthcare provider in a certified doctor's office or clinic and the spray can not be taken home. Like the ketamine sold legally for anesthesia, Spravato is a Schedule III controlled substance, along with opioid painkillers, due to the potential for abuse leading to dependence. Ketamine was approved for use as an anesthetic in the 1970s. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000. "Because of safety concerns, the drug will only be available through a restricted distribution system, and it must be administered in a certified medical office where the health care provider can monitor the patient". But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression.

NVIDIA rumored to acquire Mellanox for $7 billion
Both Bloomberg and Reuters write that Nvidia will hand over the huge sum-the most it's ever paid for a purchase-later today. Nvidia has outbid Intel Corp in the auction for Mellanox and could announce a deal as early as Monday, the person said.

Charney was part of the team that first showed two decades ago that ketamine could treat depression.

The list price of a drug is not necessarily what patients actually pay.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

The Prodigy singer Keith Flint died from hanging
In a new Instagram post , the band have shared their thanks for all fans who have sent tributes and love over the past seven days. Coroner's officer Lynsey Chaffe revealed the findings of the report during a two-minute hearing in Chelmsford, Essex.



Other News

Trending Now

Theresa May secures 'legally-binding changes' to Brexit withdrawal agreement
The deal was heavily rejected in January and May has yet to agree with Brussels any of the changes that parliament has asked for. The prime minister is banking on key lawmakers endorsing her revised deal and bringing others on-side with them.

Jaguar that attacked selfie-taking woman won't be put down
On Sunday, the woman returned to the zoo, reports AZFamily.com , to speak with the zoo's owner and apologize for her actions. The woman arm wounds caused excruciating pain, but all of her injuries were non-life-threatening.

Porsche Taycan production model confirmed for September debut
Consisting of two electric motors, the powertrain will combine to give the auto a total output of 600 hp. For a start, Porsche hasn't even revealed what the final design of the production Taycan will be.

Trump says would win Israeli election, claims 'Democrats hate Jews'
When first asked by NBC's Hallie Jackson if the president really thinks that " Democrats hate Jews", Sanders sidestepped the question.

Pres. Trump budget calls for return to 'fiscal sanity'
Cutting welfare programs is par for the course for a Republican president, and Trump has extended the ethos to foreign aid too. Lawmakers from both parties oppose the emergency declaration, but Congress appears to lack a veto-proof margin to block Trump.

Florida mother fatally stabs 11-year-old daughter, takes to hospital
Officials said Rivera then harmed herself, resulting in cuts near her wrist, before she arrived at the hospital, reports WKMG. The mother's arrest follows Rivera driving up to the medical facility and demanding medical assistance for her daughter.

Free Agent RB Carlos Hyde to Visit Chiefs on Saturday
They were frustrated by Leonard Fournette's absences and thought Hyde could help the offense along with TY Yeldon. Hyde's release allowed Jacksonville to save $4.7 million, though they initially tried to trade him, ESPN notes.

WR Danny Amendola Has Made His Free Agency Decision
Brown has started 51 games for the Patriots over the last four seasons, and he's a plus run defender. Also on Monday, former Patriots receiver Danny Amendola signed a one-year deal with the Lions.

Suns have 3-game winning streak halted by hot-shooting Blazers
With the Trail Blazers down two points, Thunder head coach Billy Donovan chose Skal Labissiere to shoot free throws for Nurkic. The Blazers were home after a largely successful seven-game, post-All-Star break road trip, during which they went 5-2.

Missing Black girl found in duffel bag identified by police; ruled homicide
An extended family member claimed on Facebook that Trinity was 'not reported missing because her mother kept her away from us. According to the Los Angeles County Sheriff's Department , two people have been detained in connection with Jones' case.