Drug Maker Unveils Experimental Drug as Opioid Alternative

A pharmaceutical company unveiled an experimental new drug that is being touted as a less dangerous alternative to opioids. To date, few drugs have demonstrated enough power to manage higher levels of pain often associated with post-surgery recovery.

WXYZ Detroit, an ABC affiliate, reports that Vertex Pharmaceuticals said Tuesday the drug’s use in late-stage clinical trials resulted in “clinically meaningful reduction in pain,” without many of the risks associated with opioids. The new drug is called VX-548 and it’s showing promise in early stages.

Two trials demonstrated that patients who recently came out of surgery who received Vertex’s new drug had statistically significant pain relief. Phase 2 trial results were published Dec. 13, 2023, noting its effects on painful diabetic peripheral neuropathy. Researchers in a third trial observed a wider range of pain-related conditions. Phase 3 trial results were published on Jan. 30, 2024 and showed “clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials,” as well as many other surgery-related conditions. 

Participants who used the drug for up to 14 days also noted positive results, with over 83% of patients saying VX-548 was “good” to “excellent” at managing pain.  

Vertex noted VX-548 was “safe and well-tolerated in all three studies,” but it failed to work better than hydrocodone bitartrate/acetaminophen, aka Vicodin. The National Library of Medicine notes that pain is a complex phenomenon, and that one type of painkiller won’t work for all situations.

Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) by mid-2024 regarding VX-548’s treatment of moderate-to-severe acute pain. Vertex’s Phase 1-3 trials move the company closer to gaining approvals from the FDA. If they are successful, it could  provide people in the U.S. with another pain treatment option.

Opioids Main Driver of U.S. Drug Overdoses

The vast majority of drug overdoses in the U.S. continues to be dominated by opioids. And to make things worse, the confusion over addiction leads to making it harder for patients who actually need opioids to get them prescribed.

According to The National Center for Health Statistics (NCHS) under the U.S. Centers for Disease Control and Prevention, drug overdose deaths rose from 2019 to 2021 with over 106,000 drug overdose deaths reported in 2021. Deaths involving synthetic opioids—primarily fentanyl and excluding methadone—continued its death march with 70,601 overdose deaths reported in 2021. Fentanyl in particular kills 150 Americans per day.

Many other attempts to develop alternatives to opioids that effectively dull pain, but they typically fail. If Vertex’s drug is ultimately deemed to be safe, it could introduce a new class of acute pain medicine for the first time in about 20 years, Dr. Jessica Oswald told WXYZ.

“As a physician treating patients suffering from pain for many years, I know firsthand the critical need for new, efficacious and safe treatment options,” Oswald said. “The Phase 3 safety and efficacy across the three studies are impressive and demonstrate VX-548’s potential to change the paradigm of pain management.”

Opioids kill more Americans than car crashes or gun violence. An alternative to effective, but highly dangerous opioids, some of which having the power to stop breathing, is sorely needed.

History of Opioid Alternatives

Bayer introduced heroin in 1898 and called it a “wonder drug” meant to be less addictive than morphine, which was ravaging America at the time with drug addicts. It wasn’t until over 10 years later that an army of heroin addicts emerged.

Cannabis itself has been explored as an opioid alternative, but it works in very different ways. One study is taking a closer look at the specific holistic effects that both medical cannabis and opioids provide to get more insight on the efficacy of each substance as it pertains to chronic pain management.

The recent study, “The holistic effects of medical cannabis compared to opioids on pain experience in Finnish patients with chronic pain,” was conducted by a team of researchers from Åbo Akademi University, who looked into the effects of medical cannabis and opioids for chronic pain treatment.

Published in the Journal of Cannabis Research, the study aimed to take a closer look at how effective medical cannabis is compared to traditional opioids in treating chronic pain, as cannabis use for symptom management has become increasingly more common in recent years. Results suggested that opioids and cannabis are both “equally efficacious” at mitigating pain intensity in patients with chronic pain, while cannabis offered more “holistic” relief in improving sleep, focus and emotional wellbeing.

Vertex Pharmaceuticals could help provide a safer alternative compared to typical opioids that have created an epidemic of drug overdoses in the U.S.