The soon-to-be marketed therapy Dsuvia has shown enough benefit, tolerability, and safety to aid an at-need patient population in a controlled setting.
James Miner, MD
Conventional opioid analgesia in medically-supervised settings primarily falls into 2 categories: injectable intravenous (IV) opioids and oral opioid tablets. No one likes being stuck with a needle, and with increasing demographics of obese and elderly patients with difficult-to-access or fragile veins, multiple IV attempts are often required in emergency departments. This undoubtedly increases discomfort, time and costs, especially if advanced techniques, such as ultrasound guidance, are required.
Oral opioids may avoid these IV challenges, but have been shown to have a slower onset of action than transmucosal and IV opioids, and thus, are not used in the emergency department (ED) or postoperative setting for severe pain. There are therefore significant advantages to having a fast-acting, non-invasive opioid to replace IV opioids in medically supervised settings.
The sufentanil sublingual tablet 30 mcg, administered by a healthcare professional from a pre-filled, single-dose applicator (DSUVIA, from AcelRx Pharmaceuticals, Inc), utilizes the sublingual route of delivery, enabling rapid analgesia (decrease in pain intensity within 15 minutes) while avoiding the time, discomfort and cost of setting up an IV line. DSUVIA is a unique analgesic product, as no other transmucosal opioid is approved for acute pain in non-opioid tolerant patients.
Currently available transmucosal fentanyl products are approved only for cancer breakthrough pain in opioid-tolerant patients and are contraindicated for postoperative and emergency department use.
I was the lead author on the recently published safety profile of the sufentanil sublingual tablet in over 800 patients, which demonstrated that this analgesic is well tolerated across a wide range of demographic subgroups, including patients who are elderly (11% ≥ 75 years), obese (42% body-mass index ≥ 30 kg/m2), and/or have comorbidities (52% ASA class II or class III).
Based on my own experience dosing DSUVIA in ED patients, as well as the results from the pooled analysis, I was impressed by the low adverse event rates of vomiting (6.5%) and decreased oxygen saturation (3.6%) following DSUVIA use. These are the 2 adverse events that we are most concerned about as physicians when treating patients with opioids. In addition, the lack of cognitive impairment is an advantage for both emergency and postoperative patients.
Sufentanil, which is metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme, does not have active metabolites, possibly reducing the potential for delayed adverse effects that are common for morphine and hydromorphone (Dilaudid), both of which have active glucuronide metabolites. As these metabolites are cleared by the kidney, patients with renal impairment can have the risk of a higher rate of side effects with these medications. The approved prescribing information for DSUVIA states that sufentanil clearance is not impacted by mild-to-moderate renal impairment.
Development of the sufentanil sublingual tablet was partially supported by the Department of Defense to replace intramuscular (IM) morphine for pain relief on the battlefield. Infection, needle-stick injuries and slow onset of analgesia complicate IM morphine dosing in the battlefield. In the civilian setting, we also need new treatment options for our patients in moderate or severe pain. In emergency departments, we’re constantly concerned with patient flow, so we don’t have patients waiting for hours in the waiting room.
I plan on using DSUVIA in place of IV opioids for patients with difficult-to-access veins and for those who may not need an IV in the first place, such as patients who do not require IV hydration or IV antibiotics. Otherwise, these patients are receiving invasive IVs only for pain management, which is not ideal from a cost or efficiency standpoint.
I understand there may be concern about bringing another opioid to market during a time when our country is grappling with how to address the ongoing outpatient opioid crisis. However, with its use restricted only to certified medically supervised healthcare settings, DSUVIA should not contribute to the crisis, and will help avoid patients’ needless suffering from delayed IV opioid administration.
In summary, I believe DSUVIA is a simple, easy-to-use replacement for IV opioids in EDs or any other short-term setting, such as a same-day surgery center, where quickly addressing a patient’s pain is important for quality care and timely discharge.
This is a column by James Miner, MD. He is the Chief of Emergency Medicine at Hennepin County Medical Center, and the Vice Chair and Research Director of Emergency Medicine at University of Minnesota. The piece reflects his views, not necessarily those of the publication.