Top Tweets for #AADPAC
FDA posts meeting materials ahead of Tuesday's adcomm. Topic: #oxycodegol, an #opioid proposed by Nektar Therapeutics for the management of certain adults with chronic low back pain $NKTR #AADPAC https://t.co/FB40fvl1eL
The @NSCsafety's new analysis shows the odds of dying from an accidental opioid-related overdose now surpasses the odds of dying from a motor vehicle accident. @US_FDA #AADPAC @stonybrooku #opioids #opioidcrisis
https://t.co/7snsPxS1g0
For all of the meeting materials for today's FDA Advisory committee meeting on naloxone availability go to this link https://t.co/7KZkPKKxzj
This means the agenda, briefing packages, webcast information, and roster #FDA #naloxone #opioidcrisis #AADPAC #DSRM $INSY $EBS $OPNT $AMPH
It's Day 2! The voting Q is: Would labeling recommending co-prescribing naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients at high risk of death from opioid overdose be effective for expanding naloxone access & improving public health?
FDA schedules Dec 17-18 advisory committee meeting to provide input and advice on strategies to increase the availability of #naloxone products intended for use in the community. #aadpac #dsrm #opioidcrisis
https://t.co/92Gc3N5Vi9
Well, it's a wrap for this week. To summarize, we had: 16-0 support for Celltrion/Teva's #rituximab biosimilar; 8-7 vote against Trevena's #oliceridine; and 10-3 support for AcelRx's DSUVIA (#sufantenil).
Have a nice weekend everyone!
#FDA $TEVA $RHHBY $TRVN $ACRX #ODAC #AADPAC
US FDA convenes 3 AdComms this week:
1) Celltrion's biosimilar of $RHHBY's Rituxan (rituximab)- https://t.co/2608OeVm9t;
2) $TRVN's #olicerdiine (#opioid) - https://t.co/0EXQ7h6Bp1; and
3) $ACRX's #sufentanil (#opioid)- https://t.co/cXqI2apqh1.
#AADPAC has voted in favor of recommending #FDA approval of $ACRX investigational therapy to treat moderate-to-severe #acutepain in medically supervised settings. News release: https://t.co/CyFCOeRVP7
#AADPAC panel votes 10-3 with no abstentions to support approval of Dsuvia with REMS as suggested by FDA $ACRX
FDA ADCOMM VOTE: Overall, do the benefits of #DSUVIA (#sufentanil sublingual tablets 30 mcg) with Risk Evaluation and Mitigation Strategies (REMS) outweigh the risks for the *proposed use, supporting its approval?
10-Yes
3-No
0 -Abstain
$ACRX #AADPAC #opioids
#AADPAC speaker #9: Pain mgmt industry rep: Inadequately treated pain leads to many unintended consequences for pts. Dsuvia could help fill unmet need, and risks of diversion lower than value of appropriate use $ACRX @acelrx_pharma
ER doc: In 20 yrs of practice, "never saw an instance" when child ingested med that fell on the floor in health care setting; more an issue in getting into grandparents' medicine cabinet at home #AADPAC $ACRX
FDA Advisory Committee meets today to review and recommend whether to approve AcelRx's sufentanil sublingual tablets
$ACRX #AADPAC
Webcast 8-5 US ET https://t.co/B0o0i9D827
Questions https://t.co/b2sjCHXqBp
Agenda https://t.co/wL9WdImwVv
Briefing Materials https://t.co/BsayWWD5m4
FDA Introductory remarks by the Review Division Direction, Dr. Sharon Hertz
(may not be fully verbatim, but should be close)
$TRVN #AADPAC #oliceridine
FDA Advisory Committee meets today to review and recommend whether to approve Trevena's #oliceridine $TRVN #AADPAC
Webcast 8am-5pm US ET https://t.co/B0o0i9D827
Committee Questions https://t.co/itERAETg2g
Agenda https://t.co/fAetAjmcgr
Briefing Materials https://t.co/Gps0ypsVnl
FDA schedules Oct 12 adcomm for proposed pain drug by AcelRx, sufentanil $ACRX
https://t.co/LedW1LASGS
#AADPAC
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