FDA Approves Esketamine Nasal Spray For Hard-To-Treat Depression

A vial of ketamine. Launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now finding new life as a treatment for depression and suicidal behavio

A vial of ketamine. Launched decades ago as an anesthetic for animals and people became a potent battlefield pain reliever in Vietnam and morphed into the trippy club drug Special K. Now finding new life as a treatment for depression and suicidal behavio

All patients will be enrolled in the Spravato REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine. Johnson & Johnson is hopeful that this drug will be approved by hundreds of centers within the first year.

Spravato, an esketamine-containing nasal spray developed by Johnson & Johnson, was tested for use with oral antidepressants as a therapy for treatment-resistant depression. The medication will be marketed under the name Spravato.

In the longer-term maintenance-of-effect trial, patients who continued the use of Spravato experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray and oral antidepressant.

For some patients who have searched for a depression treatment for years, the results of ketamine treatment have been profound.

When the drug works, its effect is nearly immediate. To lower the risk, the FDA said that the drug will only be available in certified clinics where medical professionals can monitor patients.

Lowe takes leave of absence from Williams
His departure comes after the team failed to complete its new FW42 chassis in time for it to participate in the start of testing. It is unclear relating to his long-term future at the team or whether someone will fill his position for the time being.

Now available 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 percent to 40 percent of patients with major depressive disorder (MDD). It is estimated that approximately one-third of U.S. adults with MDD have TRD. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments". They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days.

So strict will be the conditions of use around Spravato that patients will only be able to administer the nasal spray inside their doctor's office and will not be able to take the medication home with them.

The anti-depressants available at present of the likes of Eli Lilly and Co's Prozac impact the neurotransmitters - serotonin and norepinephrine. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression.

Spravato is produced by Janssen Pharmaceuticals, based in Belgium. Levesque says the effect will wear off after a few weeks depending on the patient.

Shares of Johnson & Johnson were up slightly following the FDA's approval, inching up 0.18 percent over the two-day trading period to close at US$139.09 on Wednesday (March 6).

Recommended News

  • Former Ravens S Eric Weddle signing with Rams

    Former Ravens S Eric Weddle signing with Rams

    Weddle reportedly considered retirement and has previously said the the Ravens would be the last team he played for . He registered 68 combined tackles, a sack, and three passes defensed through 16 starts with the Ravens in 2018.
    R. Kelly arrested for Failing to Pay Child Support

    R. Kelly arrested for Failing to Pay Child Support

    He thinks he can do whatever the hell he wants. "Forget the blogs, forget how you feel about me. In addition, Genson said Kelly was "not a very bright person" before explaining further.
    Tottenham reveal their first match for new 62,000 capacity stadium

    Tottenham reveal their first match for new 62,000 capacity stadium

    The first game will see Spurs' Under-18s take on Southampton at 3pm on Sunday 24 March , with a capacity of around 30,000. Tottenham say they will play either Brighton or Crystal Palace in their first match in their new stadium in April.
  • Oil edges up on Venezuela and Iran sanctions, OPEC supply cuts

    Oil edges up on Venezuela and Iran sanctions, OPEC supply cuts

    The other influencing factor is the high level of compliance among OPEC and non-OPEC members to slash their crude oil production. Next year's oil prices are expected to be in the $63 to $68 per barrel range according to expectations from 11 investment banks.

    Who won the Cleveland Browns-New York Giants trade?

    In addition to adding Zeitler, the Giants on Friday re-signed center Jon Halapio , who had been an exclusive-rights free agent. He helped the Bengals to two division titles and four postseason appearances during his five seasons in Cincinnati.
    Celebrities Shout Out The Glory Of Women On International Women's Day

    Celebrities Shout Out The Glory Of Women On International Women's Day

    There is a public holiday today in Russia, China, Vietnam and Bulgaria, where the women are considered as symbol of "struggle". Women around the world are celebrating International Women's Day on Friday and calling for action to close the gender gap.
  • Brown out as presidential candidate

    Brown out as presidential candidate

    Sherrod Brown says he won't run for president after making an exploratory swing through early-voting states. He said has never aspired to be president and, in the end, decided he could do the most good in the Senate.
    Jussie Smollett Indicted On 16 Felony Charges By Grand Jury In Chicago

    Jussie Smollett Indicted On 16 Felony Charges By Grand Jury In Chicago

    Smollett claimed the two men had beat him, said homophobic and racial slurs and put a noose around his neck before fleeing. Whoa! With all the evidence we've been hearing, the clock has been ticking on Jussie Smollett being charged with a crime.
    Disney+ streaming service to include entire Disney vault

    Disney+ streaming service to include entire Disney vault

    If you've never heard of this vault, you're probably imagining an actual magical vault, guarded by trolls and warlocks. However, some people have raised an eyebrow on whether every film will from the Vault will *actually* be available.
  • ROH Owner Purchases YES Network

    ROH Owner Purchases YES Network

    The Yankees have reportedly reached an agreement to buy back the YES Network from Disney for $3.4 billion. YES Network perennially ranks as one of the most-watched regional sports network in the country.
    Elizabeth Warren proposes breaking up giant tech companies like Amazon and Facebook

    Elizabeth Warren proposes breaking up giant tech companies like Amazon and Facebook

    They've bulldozed competition, used our private information for profit, and tilted the playing field against everyone else. A company found to violate these requirements would also have to pay a fine of 5 percent of annual revenue.
    Shamima Begum: 'Unconfirmed reports' baby son dead

    Shamima Begum: 'Unconfirmed reports' baby son dead

    Begum, now 19, told journalists that she wanted to raise her son in Britain, but the government revoked her citizenship. Kadiza Sultana was reported to have died in an air strike on Raqqa in May 2016.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.