So if you know something about opioids, then you know that there aren’t many stronger pain killers than fentanyl if any. This new drug is stronger than fentanyl and according to a report by the fda and or CDC that it’s 10x stronger than it. And 1000x stronger than morphine.
For the doctors and or any other people that wish to comment what do you think will be the use and how it would be helpful and or dangerous for patient use.
https://www.fda.gov/NewsEvents/Newsr…/ucm624968.htm
Personally after reading the FDAs statement on the matter I think as long as it stays out of the use of retail pharmacies and pharmacies in general it can be useful but making it available for a large amount of people will make the opioid crisis a lot worse as well as this doesn’t help the crisis because it just introduces another one to be prescribed.
quick quote from the manufacturers website
“DSUVIA is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a healthcare professional only in certified medically supervised settings. In a randomized, double-blind, placebo-controlled clinical study, DSUVIA demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. The pain intensity difference from baseline was superior to that of the placebo group within 15 minutes and median meaningful pain relief occurred following a single dose. The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion. The sublingual administration makes DSUVIA an option for patients with nothing by mouth (NPO) status and patients with difficult IV access (obese, elderly, burn or needle-phobic patients). Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience. There are an estimated 92 million annual adult patient visits to medically supervised settings for moderate-to-severe acute pain. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.1
“Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research. “As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management.”
“The approval of DSUVIA, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” said Vince Angotti, Chief Executive Officer, AcelRx. “We believe the unique features of DSUVIA are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of DSUVIA through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”
The DSUVIA commercial launch is expected in the first quarter of 2019.
DSUVIA efficacy and safety information
The efficacy and safety of DSUVIA were evaluated in one randomized, double-blind, placebo-controlled trial which enrolled 161 patients (age 18 to 69 years) with acute postoperative pain (pain intensity of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery (studied up to 48 hours). Patients were dosed with DSUVIA 30 mcg or placebo as needed with a minimum of 60 minutes between doses. Morphine sulfate 1 mg IV was available as rescue medication.
Patients using DSUVIA had a statistically significantly greater SPID12 than patients using placebo. Approximately 22% of patients in the DSUVIA group and 65% of patients in the placebo group took rescue medication within the first 12 hours of the treatment phase.
In controlled and uncontrolled studies, the safety of DSUVIA was evaluated in a total of 646 patients with moderate-to-severe postoperative pain or pain due to trauma which required opioid analgesia. The most frequently reported adverse reactions ≥ 2% in the randomized, placebo-controlled trial were nausea, headache, vomiting, dizziness, and hypotension. The DSUVIA clinical program builds upon the established safety and efficacy of the reference product, sufentanil citrate injection, which has been in commercial use for over three decades.
DSUVIA will not be available in retail pharmacies or for outpatient use. DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA. As part of the REMS program, AcelRx will monitor distribution and audit wholesalers’ data, evaluate proper usage within the healthcare settings and monitor for any diversion and abuse. Additionally, AcelRx will de-certify healthcare settings that are non-compliant with the REMS program.
About DSUVIA™ (sufentanil sublingual tablet, 30 mcg)
DSUVIA™, known as DZUVEO™ outside the United States, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018. For more information, please visit www.DSUVIA.com.
LIMITATIONS OF USE
Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied. Only to be administered by a healthcare provider.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.”