Nasal spray drug related to ketamine approved by FDA to treat depressionExperts believe that the OK for esketamine, a quick-acting nasal spray, is a pivotal moment in the history of mental health therapy.
MARCH 6, 201900:26March 5, 2019, 8:28 PM EST / Updated March 6, 2019, 11:21 AM ESTBy Shamard Charles, M.D.
The U.S. Food and Drug Administration on Tuesday approved esketamine, an experimental nasal spray that delivers the active ingredients of the “club drug” ketamine, as a new treatment for severe depression.
The Johnson & Johnson nasal spray is a variation of the anesthetic ketamine — a pain reliever that was widely abused as a street drug, Special K, in the 1980s and 1990s. The newly approved drug by the FDA is the first major depression treatment to reach the U.S. market in decades. It is especially effective in patients who have not benefited from at least two different therapies, also known as treatment-resistant depression, the FDA said.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a statement Tuesday.
Intravenous infusions of ketamine have been shown to help people with severe depression who experience suicidal thoughts, but the laborious process to administer the medication could be frustrating to patients. Experts believe that the FDA approval of a quick-acting, easy-to-use spray treatmentis a pivotal moment in the history of mental health therapy.
“This offers an extremely important, new treatment for people suffering with treatment-resistant depression,” Dr. Gerard Sanacora, professor of psychiatry at Yale University and director of the Yale Depression Research Program, told NBC News. “We know that if you don’t respond to the first two standard classes of antidepressants, the chances of you responding to a third or fourth reduces significantly, so this drug which has a completely different mechanism of action is particularly effective for those who have no standard treatment.”
Drugmakers believe the spray can help 30 to 40 percent of patients who don't respond to antidepressants.
The spray works more quickly than other known treatments, such as antidepressants which can take two weeks or more to take effect, showing benefits after only four hours.
“This is extremely important for people who need a drug with a quicker clinical benefit. Esketamine may shorten hospital stay or be used in people who have imminent thoughts or risks of hurting themselves,” Sanacora said.
Depression is very common. Around the world, 300 million people are affected and almost 800,000 commit suicide, according to the World Health Organization. In the United States, from 2013 to 2016, eight percent of American adults had depression in a given 2-week period, and about 80 percent of adults reported at least some difficulty with work, home or social activities because of their depression symptoms, according to the Centers for Disease Control and Prevention.
While not every person with depression thinks about suicide, the lifetime risk of attempting suicide for someone with depression is approximately 20 times that of the general population, even among those who receive adequate treatment.
Warning signs aren't always obvious, and they may vary from person to person. Some people make their intentions clear, while others keep suicidal thoughts and feelings secret, underscoring the importance of quick and effective treatment.
“Depression is thought to be the leading cause of disability around the world. At the individual level, there is a close relationship between depression and suicide. In the U.S., there are over 40,000 people a year who die of suicide, and up to 17 percent of people are affected with depression at any given time. So, it’s not only very common but it can have very serious consequences, which is a dangerous combination,” Sanacora said.
In February, a federal advisory panel said the benefits of the nasal spray outweighed the risks. The panel noted that side effects, which include dizziness, nausea, increased blood pressure and an unpleasant feeling of dissociation, should be discussed with patients.
Sanacora, who was the lead author of a consensus statement that supported ketamine's use in the treatment of mood disorders, says the drug is safe for use, but noted its potential for abuse, cautioning that the drug is still not recommended for at-home use.
“We're a long way from this being an at-home or over-the-counter drug. Drug diversion is a real concern for this class of drug, so the plan is to give the drug to providers who would then administer the drug to patients on-site,” Sanacora said.
Although today is an exciting next step for the field of novel drug development, he said, experts believe more research on its long-term use and putting measures in place to limit access to teens will play a big role in the drug's success.
“Studies looking at the long-term effects of esketamine have been conducted for up to a year, and there is an extension study that is currently ongoing. For esketamine, there was no evidence of cognitive deficits or trouble with the urinary bladder, as was seen in animal studies and those who frequently misused ketamine,” Sanacora said.
“Most antidepressant drugs are studied up to 8 weeks, so to have this one-year data is pretty unique,” he added.
Previously, the use of ketamine infusions to treat depression was not covered by insurance, and sessions ranged from $350 to $700. The wholesale price of the Johnson & Johnson drug is between $590 and $885 per session, the FDA said in a statement. Insurance coverage is anticipated.
Currently, Eli Lilly's Symbyax is the only FDA-approved drug for treatment-resistant depression.
“Esketamine isn’t to be used in place of Prozac. This is meant to be used alongside standard treatments and not instead of standard treatments. We want people to use the medicine responsibly and rationally,” Sanacora said.
What Allan, Wade Houston said about Tennessee basketball while attending Kentucky gameMike Wilson, Knoxville News SentinelPublished 8:00 a.m. ET March 6, 2019
Wade Houston was amazed Saturday.
The former Tennessee basketball coach was back in Knoxville for the game vs. Kentucky and he was floored by the fans and the environment at Thompson-Boling Arena.
“At certain games, it was good when we were here,” Houston said.
Allan Houston, Wade’s son and a Vols great, likewise was struck by the experience.
“What I thought about was there was no blue,” Allan Houston said. “Usually when you come to the Kentucky game here, they have representation. We ate up all the tickets from them. It is cool to see that.”
The Houston family was at Thompson-Boling Arena over the weekend after Vols coach Rick Barnes helped create an award in Wade Houston’s name.
On Friday, Barnes announced the creation of the Wade Houston Captain’s award, which will be given annually to a team member who shows leadership, a team-first approach and a great work ethic. He chose to name it after Houston, whom he called a “trailblazer” as the SEC’s first African-American men’s basketball coach.
Wade Houston said he did not know it was coming, while Allan Houston was involved in the creation of the award.
“It feels good to know you’re still remembered,” Wade Houston said. “I was happy just to be part of it. I know not only did it mean a lot to me, I think it meant a lot to Allan for us to come back down together.”
Said Allan: “When Rick called me at the beginning of the season to do this, it was unsolicited and unwarranted. He just said I want to honor your dad. We talked a few times throughout the season. He talked about how much he has meant to the university and to the program. For him to take that initiative and honor him, that’s what makes it truly special”
The elder Houston coached the Vols from 1989-94, going 65-90 with two NIT appearances.
Allan Houston remains Tennessee’s all-time leading scorer with 2,801 points. He ranks second in SEC history in scoring and 19th in NCAA Division I history. The younger Houston, who played 12 years in the NBA, had a chance to address the Vols after their Friday night practice.
He said he told the Vols about the opportunity to do something great and never before seen in Tennessee basketball history.
Former Tennessee coach Wade Houston and player Allan Houston attended Saturday's game against Kentucky Mike Wilson, USA TODAY NETWORK - Tennessee
A day later, while Tennessee handled Kentucky in dominant fashion, Allan Houston stressed how impressed he is with the Vols.
“It’s the character of the players,” he said. “That’s the biggest thing to me. It’s the character of the players, the staff, Rick and everyone. It is the culture that they have built. That is really to me what I have been enthusiastic about.
“When I got a chance to talk to some of those guys, I told them it’s their responsibility to carry that on because it’s you as people who are making this happen this way.”
Lionel Messi: Why is Barcelona star not playing against Girona in Supercopa de Catalunya?
LIONEL MESSI: Starsport reveals why the Barcelona superstar is not playing in this evening’s Supercopa de Catalunya match against Girona.
By Alex Harris / Published 6th March 2019
Barcelona: Team train ahead of clash against Girona
The Supercopa de Catalunya sees the top two teams in Catalunya face each other in a one-off match.
Barcelona and Espanyol have traditionally dominated the competition, despite regularly fielding under-strength teams.
Girona finished higher in La Liga last term, meaning they could win the cup for the first time in their history.
As a result of the tournament being low on Barcelona’s priority list, Ernesto Valverde has given a host of his big-name players a breather.
Lionel Messi is the standout player not included in Valverde’s squad for the fixture.
Marc-Andre Ter Stegen, Nelson Semedo, Gerard Pique, Clement Lenglet, Jordi Alba, Sergi Roberto, Ivan Rakitic, Sergio Busquets, Philippe Coutinho, Luis Suarez, Ousmane Dembele and Arturo Vidal have joined Messi in being given a break.
Rafinha and Thomas Vermahlen are injured.
Barcelona XI: Cillessen, Wague, Miranda, Todibo, Collado, Riqui Puig, Malcom, Murillo, Prince, Alena, Umtiti
Lionel Messi is not playing for Barcelona against Girona in the Supercopa de Catalunya (Pic: GETTY)
Lionel Messi is joined in the stands by Luis Suarez and Gerard Pique (Pic: GETTY)
Meanwhile, Barcelona president Josep Maria Bartomeu has admitted he “cannot imagine” the club being without Messi.
"At the moment we cannot imagine it, but we have to prepare for it," Bartomeu told Marca.
"It will be a very different Barcelona, we have to look for young talent.
"Leo has a contract until 2021 and we will also do another renewal. He has the ambition to win titles."
Lionel Messi squares up with Sergio Ramos in HEATED clash
Jasper Cillessen starts in goal for Barcelona against Girona (Pic: GETTY)
Barcelona vs Girona TV details
The Supercopa de Catalunya is only available on Catalan TV channel TV3.
The game kicks off at 5.45pm GMT (6.45pm CET).
Barcelona will broadcast a full replay of the game on their official YouTube channel from 8.15pm GMT (9.15pm CET).
Barcelona vs Girona live stream, TV channel, team news, and kick off time for Supercopa de Catalunya 2019 final
Catalan pride is up for grabs as Barcelona look to retain their position as the region's top dogs
By Sam Street 6th March 2019, 6:18 pm
Updated: 6th March 2019, 6:19 pm
BARCELONA are looking to remain Catalan champions as they face Girona.
The Spanish champs picked up last year's trophy with a win on penalties after a 0-0 draw in their derby against Espanyol.
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But Girona could prove a tough test for the young Barca squad, after holding the senior team to a 2-2 draw at the Nou Camp earlier this season.
When is Barcelona vs Girona?
The Supercopa de Catalunya will take place on Wednesday, March 6 - TODAY.
It will kick off at 5.45pm UK time - 6.45pm in Catalunya.
The game will be played at the Nova Creu Alta, Sabadell.
What TV channel is Barcelona vs Girona on and can I live stream it?
Unfortunately, the match will not be live on TV or online in the UK.
But you will be able to stream the entire game on delay on the official Barcelona YouTube channel at 8.15pm UK time.
In Catalunya the game will be live on TV3 or online on Esport3.
What is the Supercopa de Catalunya?
The Supercopa de Catalunya takes place between the two top placed Catalan teams in La Liga.
Since 2014 it had been held once every two years, but it has now been turned into an annual competition.
This year's Supercopa is the first time Girona, rather than Espanyol, have made it into the event.
Supercopa de Catalunya past results:
2014: Barcelona 0 Espanyol 0 (4-2p)
2016: Barcelona 0 Espanyol 1
2018: Barcelona 0 Espanyol 0 (4-2p)
Barça XI FC Barcelona v Girona #SupercopaCAT
Pauleta: 'Mbappé reminds me of CR7'
05 March at 17:30
Former PSG and Portugal striker Pedro Pauleta spoke to L'Equipe about the new star of the French club, Kylian Mbappé, in very flattering terms.
"He is a player who can make the difference at any time, he has reached a very high level and he has already won a lot, even if it is still just at the beginning of his career, he can reach the level of Lionel Messi or Cristiano Ronaldo and win several Golden Balls, PSG has done a lot for him, I hope he stays. always keep learning and going even higher. Kylian reminds me of Cristiano Ronaldo, who also started playing outside and then he focused. I also see it as a number 9 ".
Pauleta scored 76 goals in 168 games for PSG and was there all-time top goal scorer before Ibra and Cavani’s arrival.
Chick-fil-A is offering a special fish sandwich during Lent
by KEVIN CONNELL, WJLA
Wednesday, March 6th 2019
Chick-fil-A Fish Sandwich (Courtesy of Chick-fil-A)
Select Chick-fil-A locations will offer the Chick-fil-A Fish Sandwich for a limited time between Wednesday, March 6 and Saturday, April 20 during Lent.
March 6 is Ash Wednesday, the first day of Lent when a roughly 40-day period of penitence begins for Christians. It concludes with the celebration of Easter, which is on Sunday, April 21 this year.
Chick-fil-A is never open on Sundays, meaning the last day the Fish Sandwich is available is the day before Easter.
The Fish Sandwich will join the Chick-fil-A menu, along with the Deluxe Fish Sandwich and boxed two- and three-count fish entrees and meals, served with Waffle Potato Fries. The sandwiches are 370 and 430 calories, while the two- and three-count boxes are 190 and 280 calories, respectively.
Since not all Chick-fil-As will offer the Fish Sandwich, make sure to check with your local restaurant to see if it is offering the entrees.
The last Chevrolet Cruze is scheduled to roll out of the General Motors plant in Lordstown, Ohio, on Wednesday afternoon.
Workers at the soon to be idled facility have been chronicling the sedan’s journey down the assembly line with photos released to local news outlets since last week. More as a protest than a celebration, as they are facing job losses or transfers to other General Motors facilities.
In one image posted to WKBN last week, the phrase “we succeed despite you” can be seen written on the car’s unibody. Another provided to WFMJ on Tuesday shows a group shot of workers outside of the paint shop holding up signs that read “GM, we invested in you. Now it’s your turn to invest in us,” alongside the white car draped in an American flag.
Last Chevy Cruze expected to come off line Thursday morning http://www.wfmj.com/story/40074450/last-chevy-cruze-expected-to-come-off-line-thursday-morning …
The message is a reference, in part, to the United Auto Workers union’s role in General Motors emergence from bankruptcy a decade ago, when a union trust took a stake in the company in exchange for assuming responsibility for some retiree benefits.
The Lordstown facility is one of two final assembly plants in the U.S. set to be “unallocated” this year, due to dwindling demand for their products as the market shifts toward utilities and trucks. Production at the other one in Detroit, however, has been extended to 2020 and GM President Mark Reuss said in January that the automaker is "looking at a lot of different options" for Lordstown. The UAW has filed a lawsuit arguing that the plant is effectively being closed in violation of its collective bargaining agreement with GM.
The first car built at the facility was a white 1966 Chevrolet Impala (General Motors)
The first vehicle built at the factory when it opened in 1966 was a white Chevrolet Impala, whose whereabouts are today unknown, and 16 million cars and trucks have come out of it since then. Among them were 1.9 million Chevrolet Vegas, which is approximately the same number of Cruzes it has produced.
Around 1.9 million Chevrolet Vegas were built at the Lordstown plant. (Getty Images)
President Obama visited the plant in 2009 and signed the hood of a Cruze prototype heralding the fuel efficient compact as “the car of the future,” while Reuss drove the first production car off the line the following year when he was president of GM’s North American operations.
GM President Mark Reuss drove the first Cruze off of the assembly line in Sept. 2010. (General Motors)
The destination of the last American-made Cruze has not been officially announced. The model is still produced and sold in several locations around the world.
Netflix to Adapt Gabriel Garcia Marquez's 'One Hundred Years of Solitude' for TV
6:28 AM PST 3/6/2019 by Etan Vlessing
The classic novel will be turned into a Spanish-language original series for the streaming giant.
Nobel Prize winner Gabriel Garcia Marquez’s signature novel One Hundred Years of Solitude is headed to Netflix.
The video streaming giant has acquired the rights to develop the literary classic, first published in 1967, as a Spanish-language TV series. Garcia Marquez’s sons Rodrigo Garcia and Gonzalo Garcia Barcha will executive produce the series, to be shot in Colombia.
"For decades our father was reluctant to sell the film rights to Cien Anos de Soledad because he believed that it could not be made under the time constraints of a feature film, or that producing it in a language other than Spanish would not do it justice,” said Garcia in a statement.
The Colombian writer's other novels like Chronicles of a Death Foretold and Love in a Time of Cholera were adapted as movies or TV series, but Marquez never allowed the rights to One Hundred Years of Solitude to be optioned as he couldn't see how a novel about the Buendia family told over many generations could be adapted for the big or small screen.
But Garcia said the talent in writing and direction required to turn his father's novel into a TV series was now at hand. "We are excited to support Netflix and the filmmakers in this venture, and eager to see the final product," Garcia added.
Francisco Ramos, vp Spanish language originals for Netflix, added in his own statement: “We are incredibly honored to be entrusted with the first filmed adaptation of One Hundred Years of Solitude, a timeless and iconic story from Latin America that we are thrilled to share with the world."
Just over a half century since Garcia Marquez's novel was published, it has sold an estimated 47 million copies, been translated into 46 languages and become a classic of Latin American literature.
On the Spanish language front, Netflix is also producing a school-set drama, El Desorden que Dejas, by the co-creator of hit Netflix series Elite, the movie thriller Hogar and an animated Christmas family comedy Klaus, from director Sergio Pablos.
Netflix has also launched a production hub in Madrid, Spain, which is set to be unveiled April 4.
Attorney Shelley Surpin and the Agencia Literaria Carmen Balcells represented Gabriel Garcia Marquez's estate in the deal.
'REAL HOUSEWIVES OF NEW YORK' SEASON 11 PREMIERE: HOW TO WATCH, SPOILERS AND MOREBY JANICE WILLIAMS ON 3/6/19 AT 10:22 AMPauseUnmuteCurrent Time?0:01Duration?3:10Loaded: 0%Progress: 0%QualityHDFullscreen'Real Housewives Of New Jersey' Season 7 TrailerSHARECULTUREMOVIES & TV
Drama will blow across the Big Apple when the Real Housewives of New York City returns to Bravo on Wednesday night. Similar to past episodes of the show, Season 11 is expected to be quite the doozy when the cast reunites with a few old and new faces.
Ramona Singer, Sonja Morgan, Bethenny Frankel, Luann de Lesseps, Dorinda Medley and Tinsley Mortimer are all slated to make their grand return on the new season of the Bravo reality show along with newcomer and de Lesseps’ gal pal Barbara Kavoit. RHONYC alum Jill Zarin is also reportedly returning to the show following her Season 4 departure.
There will be one notable housewife missing in action on Season 11. Following her blowout with Frankel last season, Carol Radziwill stepped down from the show. The author announced her decision to part ways with the long-running reality series to revive her career in July 2018. “After six seasons on Bravo’s RHONYC, I have decided to return to what I do best— journalism and producing. I am sure this does not come as a surprise to any of the viewers, all of whom have been supportive, encouraging, and kind,” Radziwill said in a statement to Us Weekly.
She added: “My original curiosity about reality television has waned over the years and I am focusing on TV and writing projects that better suit my more steady temperament. I have worked with amazing producers, made great friends, and I’m thrilled to leave frenemies behind. I will remember this entire experience with delight, humor, and a veracious accuracy.”
While fans won’t get to see Radizwill and Frankel air out their friendship woes on the show, there will still be plenty of feuds for viewers to keep up with during the season, particularly de Lesseps’ continued fighting with cast members like Frankel and Medley. The trailer for the Bravo reality show hinted at a ton of tension brewing between the housewives and a rather explosive but therapeutic trip to Medley’s Berkshires home.
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Fans will also see Frankel grieve the loss of her on-and-off-again boyfriend Dennis Shields on Season 11 after the 51-year-old died from a suspected drug overdose in August. “There was a lot in my mind about him dying,” Frankle said in the trailer. “I could not get off the ride. I feel guilty that the only way I could get off the ride is that he’s dead.”
Season 11 of RHONYC is set to premiere on Bravo at 9 p.m. on Wednesday. Viewers will be able to live stream the season kick off on Bravo’s website and app with a cable provider login.
PSG vs. Manchester United: Paris Saint-Germain fans are getting rowdy with flares before Champions League matchPSG fans are welcoming Manchester United to a raucous environment in Parisby Kevin Skiver @skiverK93 hrs ago • 1 min read
Manchester United is already down 2-0 in the aggregate against Paris Saint-Germain ahead of Wednesday's Champion League match, but the Red Devils have another key component that they're going up against: The rowdy Parisians. PSG turned out en masse for its home leg against Manchester United, and they've been letting Manchester United hear it. The match kicks off at 3 p.m. ET and you can stream it via fuboTV (Try for free).
Seriously, PSG is READY. They have flares, fireworks, you name it.
Welcome to Paris
Manchester United, of course, will be without Paul Pogba, so the odds of them coming down from the 2-0 aggregate deficit on the road are slim. PSG and its fans are doing nothing to make Parc des Princes more accommodating.
Paris Saint-Germain, of course, is looking to make it to the Champions League quarterfinals for the first time in three years, and its sights are set on advancing either further. For its dominance of Ligue 1, Paris Saint-Germain has struggled in the Champions League, so the excitement for this season is palpable.
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