Sufentanil, sold under the brand names Dsuvia and Sufenta, is a synthetic opioid analgesic drug approximately 5 to 10 times as potent as its parent drug, fentanyl, and 500 times as potent as morphine. (wikipedia.org)
It is available as a sublingual tablet under the trade name Dsuvia. (wikipedia.org)
In 2018, the Food and Drug Administration (FDA) approved Dsuvia, a sublingual tablet form of the drug, that was developed in a collaboration between AcelRx Pharmaceuticals and the United States Department of Defense for use in battlefield settings where intravenous (IV) treatments may not be readily available. (wikipedia.org)
DSUVIA® (Sublingual Sufenanil): an enteral form of sufentanil FDA approved for management of moderate to severe pain. (asda.org)
In November of 2018, its lead product candidate DSUVIA® (sufentanil sublingual tablet 30 mcg) was approved by the U.S. Food and Drug Administration. (asra.com)
The Company's product candidates, DSUVIA™ (known as ARX-04 outside of the United States) and are designed to deliver sufentanil, a strong opioid analgesic, via a non-invasive, sublingual formulation in medical supervised settings. (chemical.report)
DSUVIA is designed to deliver sublingual tablets containing 30 mcg sufentanil via a disposable, pre-filled, single-dose applicator. (chemical.report)
Its lead product candidate is DSUVIA and DZUVEO, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain. (stockinvest.us)
In this particular case, Dsuvia is a sublingual (under the tongue) formulation of sufentanil that's delivered through a disposable, pre-filled, single-dose applicator. (healthjobsnationwide.com)
Dsuvia is a new brand name for a prescription opioid painkiller , sufentanil, which is a very potent narcotic analgesic. (serenityatsummit.com)
Dsuvia, in particular, and sufentanil in general, is designed to treat acute, severe pain when other pain medications are ineffective. (serenityatsummit.com)
Opioid8
Currently sufentanil is the most potent opioid painkiller available for use in humans. (wikipedia.org)
It contains 30 micrograms of a synthetic opioid painkiller known as sufentanil, which is 5 to 10 times more potent than fentanyl, and 1,000 times more potent than morphine. (healthline.com)
This opioid medication is prescribed in sublingual tablets, using the mucous membranes in the mouth to quickly release pain-killing medication into the blood so that it can bind with opioid receptors in the brain and bring rapid relief. (serenityatsummit.com)
Although Dsuvia's primary ingredient, sufentanil, is a Schedule II medication, opioid drugs related to it (like fentanyl) have been diverted, produced illicitly, and widely abused. (serenityatsummit.com)
An increase in illicit fentanyl production and distribution - it is often mixed into heroin or cocaine - has led to a spike in opioid overdose deaths around the United States because fentanyl and its analogs, like sufentanil, are much more potent than morphine and heroin. (serenityatsummit.com)
Fentanyl Pills In the mid-1990s, fentanyl was introduced for palliative use with the fentanyl patch, followed in the next decade by the introduction of the fentanyl lollipop, dissolving tablets, and sublingual spray which are resorbed through the skin inside the mouth.As of 2012 fentanyl was the most widely used synthetic opioid in medicine.In 2013, 1700 kilograms were used globally. (assuredpharmaceutical.com)
Buprenorphine for Opioid Use Disorder Current information on the use of sublingual and transmucosal buprenorphine for the medication assisted treatment of opioid use disorder. (starkmhar.org)
If bicalutamide is discontinued, consider growing the sufentanil injection dose until stable drug effects are achieved and monitor for evidence of opioid withdrawal. (page.tl)
Tablets3
In a review the FDA found sublingual sufentanil tablets to be efficacious for moderate-to-severe acute pain but had concerns over the maximum dosing and the risk of misplaced tablets due to their small size. (prescriberight.com)
AcelRx and the FDA have both proposed a REMS program for sublingual sufentanil tablets. (prescriberight.com)
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval of sublingual sufentanil tablets. (prescriberight.com)
Zalviso1
In addition, the company has also received approval for a patient controlled analgesia system (PCA) in the EU, known as Zalviso® (sufentanil sublingual tablet system). (asra.com)
Potent3
Although more potent narcotic pain medications do exist, all medications stronger than sufentanil are approved for veterinary use only. (wikipedia.org)
citation needed] Because sufentanil is very potent, practitioners must be prepared to reverse the effects of the drug should the patient exhibit symptoms of overdose such as respiratory depression or respiratory arrest. (wikipedia.org)
But underlying the debate surrounding this approval is a broader issue that must be addressed head on: why do we need an oral formulation of sufentanil - a more potent form of fentanyl that's been approved for intravenous and epidural use in the U.S. since 1984 - on the market? (healthjobsnationwide.com)
The company's non-invasive, sublingual formulation technology is designed to efficiently deliver highly lipophilic drugs with consistent pharmacokinetic profiles. (asra.com)
Fentanyl1
Structurally, sufentanil differs from fentanyl through the addition of a methoxymethyl group on the piperidine ring (which increases potency but is believed to reduce duration of action), and the replacement of the phenyl ring by thiophene. (wikipedia.org)
Sufenta1
Sufentanil is marketed for use by specialist centers[clarification needed] under different trade names, such as Sufenta and Sufentil. (wikipedia.org)
Management1
and entitled "Evaluation of Sufentanil Sublingual Tablet 30 mcg for Perioperative Pain Management of In-Office Rhinology Procedures. (acelrx.com)
Approval1
But at the same time, the head of FDA's own advisory committee warned the administration that approval of the new version of sufentanil will only make overdoses that much more likely. (healthline.com)
Moderate-to-severe acute pain1
The study combined data from three phase 3 studies of sublingual sufentanil administered at 30-μg dose equivalents over a period of 72 hours or less for moderate-to-severe acute pain management used in the postoperative and emergency department settings. (medscape.com)
Self-dose1
The Company just released top-line results for the Phase 3 trial with very positive results, as the trial demonstrated that ACRX met its primary endpoint for the non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. (goldmanresearch.com)
Acute1
Sublingual sufentanil was approved by the US Food and Drug Administration (FDA) in November for use in adults in a certified medically supervised healthcare setting, such as hospitals and surgical centers, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (medscape.com)
Adverse1
Overall, adverse events were experienced by 60.5% of patients in the sublingual sufentanil group and 61.4% in the placebo group. (medscape.com)
Patients2
The potential for cognitive impairment with sublingual sufentanil was assessed in the open-label SAP302 study of patients treated in the emergency department, which Miner led. (medscape.com)
A total of 75 patients who received 30 μg sufentanil were evaluated pre-dose and 1-hour post-dose for cognitive impairment using a validated six-item screening tool. (medscape.com)
Product1
The letter ACEP wrote to the FDA on sublingual sufentanil was "quite clear in saying we don't need this medicine, there is no indication for this product, there is no failure of the currently available opioid modalities, and so this is really a solution in search of a problem," he noted in an interview with Medscape Medical News . (medscape.com)