Due to the prevalence of prescription opioid abuse in the United States, the development of abuse-resistant pain medications has been a focus for many pharmaceutical companies in recent years. Purdue Pharma LP produced a tamper-resistant form of Oxycontin in 2010, and the US Food and Drug Administration (FDA) approved Pfizer’s morphine drug Embeda® with an abuse-deterrent label in 2014 and Purdue’s hydrocodone drug Hysingla® with an abuse-deterrent label in 2014. However, the agency warned that abuse-deterrent drugs do not protect from all forms of abuse. In 2013, the FDA also approved Zogenix’ Zohydro® ER (hydrocodone bitartrate), even though it was not designed to be abuse resistant.
We examine 3 alternative medications currently in development for the treatment of postoperative and chronic pain.
1. ARYMO™ ER (morphine sulfate) extended-release (ER) tablets C-II
The Egalet Corporation received FDA approval in January 2017 for an extended-release morphine sulfate tablet (ARYMO ER) for the treatment of chronic pain. This tablet has been designed to resist “cutting, crushing, grinding, or breaking.” Because the tablets turn into a viscous hydrogel when in contact with liquid, they cannot easily be turned into an injectable form. The tablets are available in 15-mg, 30-mg, and 60-mg doses.
2. ARX-04, known as DSUVIA™ (sufentanil sublingual tablet, 30 µg)
AcelRx Pharmaceuticals, Inc, has submitted a New Drug Application to the FDA for DSUVIA, a sublingual tablet administered using a single-dose applicator in the treatment of moderate to severe acute pain. This drug is meant to be an alternative to intravenous opioids in postoperative settings and emergency departments.
In September 2016, AcelRx completed 3 phase 3 trials (SAP301, 302, and 303) that comprise the ARX-04 phase 3 clinical program. SAP301 showed that over the first 12 hours of treatment patients receiving ARX-04 had significantly more pain relief than patients in the placebo group; SAP302 compared a single dose of ARX-04 with multiple doses as needed; and SAP303 measured improvements in pain intensity in 140 patients.
3. Combined bupivacaine and anti-inflammatory meloxicam: a local anesthetic after abdominoplasty
Heron Therapeutics has announced results from its phase 2 trial of HTX-011 for postoperative pain. The locally administered HTX-011 combines the local anesthetic bupivacaine with the anti-inflammatory meloxicam into a single-administration local anesthetic that is meant to reduce or eliminate the need for opioids following abdominoplasty. This is the first long-acting anesthetic designed to address both postoperative pain and inflammation in this way.
Results from the phase 2 clinical study showed that HTX-011 produced a statistically significant reduction in pain 96 hours after surgery (36.6%, P =.0104).
- FDA approves Arymo ER [news release]. Drugs.com.www.drugs.com/newdrugs/fda-approves-arymo-er-morphine-sulfate-abuse-deterrent-formulation-chronic-pain-4471.html. Accessed January 17, 2017.
- ARX-04 pipeline. AcelRx Pharmaceuticals, Inc. www.acelrx.com/pipeline/arx04.php. Accessed January 17, 2017.
- Heron therapeutics announces positive topline results from phase 2 clinical trial of HTX-011 in abdominoplasty [news release]. BusinessWire. www.businesswire.com/news/home/20170104006395/en/Heron-Therapeutics-Announces-Positive-Topline-Results-Phase. Accessed January 17, 2017.