Tuesday, 25 Feb 2020

You are here

Controversial New Super Opioid Approved by FDA

Amidst a new DEA report demonstrating a record number of opioid overdose deaths (n-72,000 or ~ 200 deaths per day), the FDA has approved a newer and far more potent opioid than those that are currently being abused at alarming rates.  The new agent is named Dsuvia.

However, since its approval last week, advocacy groups and politicians have criticized the FDA’s approval of Dsuvia, a drug they believe will only add to the current crisis of opioid abuse. 

Dsuvia (sufentanil sublingual tablet 30 mcg) was approved on November 2nd and is indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings. It is unique in being the first and only sufentanil sublingual tablet approved for acute pain in healthcare settings.

Dusuvia is the tablet form of sufentanil that use to be given sublingually. It's five to 10 times stronger than fentanyl, and 500 to 1000 times more powerful than morphine. 

FDA commissioner, Dr. Scott Gottlieb has issued a statement about this particular approval, noting "Dsuvia is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. Dsuvia.... has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee."

The FDA has approved this drug with "very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise."

The manufacturer, AcelRx, estimates Dsuvia’s market potential to be approximately $1.1 billion in the United States alone. The U.S. launch is expected in the first quarter of 2019. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

JAK Inhibitors Stimulate Osteoblasts

Science Translational Medicine has a report on how the use of Janus kinase (JAK) inhibitors may boost osteoblasts to battle bone erosions in conditions like rheumatoid arthritis (RA).

JAK inhibitors have been shown in clinical trials to retard the development of bone erosions while controlling RA inflammation and other clinical features.

Hormone Therapy for Postmenopausal Women

The NEJM weighs in on the problem of post-menopausal osteoporosis (OP) and tackles the use of hormonal therapy. The decline in estrogen after menopause may increase risks for osteoporosis, cardiovascular disease, and cognitive decline. The use of hormone replacement therapy (HRT) to obviate these issues may be primarily driven by hot flashes in postmenopausal women.1 Who may benefit from hormone therapy among postmenopausal women?

Knee Replacements Last 25 Years

UK registry reports that greater than 80% of total knee replacements can last for 25 years.

The outcomes regarding the duration and durability of knee arthroplasties is sketchy, with many orthopedists projecting a 15 to 20 year survivial. Hence the need for an appraisal of the data.

Should We Screen Younger Postmenopausal Women for Osteoporosis?

Do postmenopausal women, under age 65 years, need a baseline BMD testing? A JAMA Insights review suggests that the absolute risk of fracture is low in this group and that USPSTF guidelines should be considered - that we should be screening women younger than 65 years who are at increased risk of osteoporosis and we should be using a formal risk assessment tool to identify candidates for bone density testing.

Genicular Artery Embolization to Treat Osteoarthritis Knee Pain

A study from the Journal of Vascular and Interventional Radiology has shown that  knee pain secondary to osteoarthritis (OA) may be effectively treated by selective vascular interruption (embolization) showing efficacy and safety in a small pilot trial.