USAID administrator visits Egypt, praises religious pluralism    Lebanon says US Golan decision undermines peace    Egypt MPs give comments on proposed constitutional amendments in internal dialogue    Egypt's Sisi discusses economic, military cooperation with Chinese defence minister in Cairo    Forgiveness: The Secret of Peace    Alganesh: finding hope in abyss    USAID, local partners discuss development of Egypt's livestock production systems    Thousands of visitors line up to explore Tutankhamun's life    On pleasing audience: Mahmoud Hemeda gives acting masterclass during Luxor African Film Festival    Two smuggled statues retrieved from Switzerland    Expanding services in oil sector is essential to maximising value: Petroleum minister    Ethiopian Airlines CEO promises to get to bottom of flight 302 crash    Zimbabwe confirm death of fan before Cup of Nations qualifier    Tennis: Djokovic beats Delbonis, stays on track for seventh Miami title    Southgate says youngsters will handle hostile Montenegro atmosphere    'Time's up, Theresa'? PM May urged to set her own exit date to get Brexit deal    Egypt's Parliament expected to conclude dialogue over constitutional amendments in April    British Petroceltic files arbitration case against EGPC    Government negotiates with Hassan Allam to establish 2 water treatment plants for EGP 2bn    Mamish, El-Gazzar head Egyptian delegation to Makkah Economic Forum 2019    Druze protest Trump's recognition of Israeli sovereignty over Golan Heights    Not German Christian Democrats    Up-fuse, Farahzada El Shihy create ‘The Ripples'    Irrigation Minister asks Egyptians to be ‘more concerned' over water scarcity    Gap between rich, poor in Egypt shrinking, middle class doing worse: LSE Director    Jadon Sancho is the type of player England has and Germany wants    Euro 2020 qualifying: Germany look to emulate neighbors in period of evolution    Supreme Media Council block Al-Mashhad newspaper    Passengers airlifted from cruise ship stranded off Norway    Pope accepts resignation of Chilean cardinal accused of covering up abuse    Meet Egypt's youngest female football coach    Tutankhamun goes to Paris    Disney closes $71B deal for Fox entertainment assets    International Universities to start its next academic year in the New Capital    Darts for all    Greta    To be continued    A Broken Window play is the latest at Taliaa Theatre, don't miss it    Mustafa Al-Razzaz's art is on show at the Gezira Arts Centre    Don't miss Asmaa Waguih's photography show at the AUC Photographic Gallery    New horizons    Diaa Rashwan    Christchurch terror    Another year for Syria?    National dialogue begins    Egypt parliament provisionally approves bill on protecting personal data    Uganda releases 14 Egyptian expats after embassy intervention    Right man for the right job    







Thank you for reporting!
This image will be automatically disabled when it gets reported by several people.





Amid controversy: nasal spray for depression wins FDA panel backing
Published in Ahram Online on 17 - 02 - 2019

An advisory panel to the U.S. Food and Drug Administration on Tuesday voted in favor of Johnson & Johnson's experimental nasal spray, which has a compound similar to often-abused ketamine, bringing the drug closer to approval.
The panel voted 14-2 in favor of the drug esketamine, developed to treat major depression in patients who have not benefited from at least two different therapies, saying its benefits outweighed the risks. One panel member abstained from voting.
Esketamine 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”.
“I think esketamine has the potential to be a game-changer in the treatment of depression ... I use the term potential because the issues of cost and patient accessibility need to be addressed,” said Walter Dunn, who voted in favor of approval.
However, the panel members echoed concerns raised by FDA staffers on Friday regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study.
Advertisement


The FDA recommended implementing a risk evaluation and mitigation strategy (REMS) program which included ensuring esketamine is only dispensed and administered under supervision.
“Ketamine is a nasty drug ... should (J&J's) drug get approved, I think a strong effort has to be given as part of REMS ... so that patients really know what they are getting themselves into,” said Steven Meisel, another member who voted ‘yes'.
Major depressive disorder affects over 300 million people globally. About 30 percent to 40 percent of these patients fail to respond to first-line treatments such as antidepressants, most of which take at least four weeks to show effect.
However, depression is a tricky area of development. Patients in clinical trials often show a big placebo response, masking the efficacy of the drug being tested.
Currently, Eli Lilly and Co's Symbyax is the only FDA-approved drug for treatment-resistant depression.
“There is a lot of potential for people that just want that quick fix. I really would be cautious,” said Kim Witczak, a panel member who voted ‘no'.
J&J's esketamine, used in combination with a newly prescribed antidepressant, works by restoring the nerve cell connections in the brain, leading to an improvement in depression symptoms.
The FDA, although not mandated to follow the panel's recommendation, is expected to announce its decision on esketamine by March 4.


Clic here to read the story from its source.