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#Oxycodegol, a new molecular entity receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.$NKTRPrikaži ovu nit -
FDA panel Qs for
$NKTR#oxycodegol smash cut from approvability concerns to possibly expanding the proposed indication. Were trial participants adequately non-responsive to non-opioids? Is a single trial OK? Is liver safety and abuse liability OK? (1/2)Prikaži ovu nit -
FULL ARTICLE: FDA Advisory Committee denies the approval of a new opioid drug due to safety concerns. http://ms.spr.ly/6012TkIx6
#oxycodegol pic.twitter.com/6O6MNABacr
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After the
#FDA AdCom rejected#oxycodegol$NKTR withdrew the NDA https://lnkd.in/e8uettF -
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Update: Nektar announced in PR last night that they will withdraw the
#oxycodegol NDA$NKTRhttps://ir.nektar.com/news-releases/news-release-details/nektar-issues-statement-regarding-fda-advisory-committee-vote …Prikaži ovu nit -
#FDA committee rejects#oxycodegol, new#opioid designed for less abuse http://bit.ly/38fy7f3 pic.twitter.com/rLZkSGcyBo
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Nektar won't do those tests and it's not waiting to see what the FDA says. Hours after the panel vote, the company announced it will withdraw its application and stop investment in the
#opioid drug,#oxycodegol.$NKTR announcement here:https://www.prnewswire.com/news-releases/nektar-issues-statement-regarding-fda-advisory-committee-vote-for-oxycodegol-300987219.html …Prikaži ovu nit -
Spoiler: unanimous FDA vote. Wow.
#oxycodegol https://twitter.com/FDAadcomm/status/1217076690591109120 … -
The
#FDA AADPAC/DSARM Committees voted#oxycodegol down, 27 - 0.#BalancingRisksAndBenefits@Med_Shadow -
#FDA advisory committee votes 27-0 against approval of#oxycodegol, new opioid molecule designed to give pain relief with slower brain entry and less of a high, largely bc of inadequate safety and efficacy data.#MDedgeTweets https://bit.ly/30kkWql -
Welcome to new followers of the Nektar
#oxycodegol adcomm!$NKTR -
I really wonder what Dr. Sharon Hertz (the former Director of FDA's pain products review division) is thinking about the
#oxycodegol adcomm, assuming she's following from outside of FDA. I've gotten so used to her voice at these meetings. -
The
@US_FDA must not approve the new#opioid#oxycodegol, which is closely related to#oxycodone, for treatment of chronic low back pain because the medication is not effective for treating this condition and poses a high risk of being abusedhttps://www.citizen.org/article/testimony-before-the-fdas-anesthetic-and-analgesic-drug-products-advisory-committee-and-drug-safety-and-risk-management-advisory-committee-regarding-the-opioid-oxycodegol/ … -
Today is the FDA ad comm, where they review a drug already pushed off for approval (issued a CRL). Do we really need
#oxycodegol....another long acting opioid? I’m so glad we spend more $ than other countries to spawn this sort of “drug innovation.”
https://twitter.com/davidjuurlink/status/1213594152841158656?s=21 … -
Do we really need
#oxycodegol?@US_FDA I’m so glad we spend more money on drugs than other countries to spawn this sort of “innovation.”
https://twitter.com/davidjuurlink/status/1213594152841158656?s=21 …https://twitter.com/DavidJuurlink/status/1213594152841158656 …
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