Studies suggest experimental drug could be alternative to opioids: What to know
The drug's manufacturer says they'll apply for FDA approval this year.
A pharmaceutical company has presented new data for an experimental drug that they say can reduce acute pain, raising the possibility of an alternative to addictive opioids.
In a press release, Vertex says two studies showed that the new drug, VX-548, showed a "clinically meaningful reduction" in pain over a 48-hour period, compared to a placebo. The studies evaluated people who had recently undergone surgery and needed something to treat "acute pain" that lasts a short time.
Vertex described the drug as "safe and well tolerated" in the studies. The study results haven't yet been vetted as part of the normal scientific review process.
The company plans to ask the Food and Drug Administration for approval of VX-548 in mid-2024 to treat "moderate-to-severe acute pain."
For decades, researchers have been looking for ways to treat significant pain without using opiate-based painkillers, such as oxycodone, hydrocodone and morphine. Opioids generally work better than other medications for that purpose but also carry the risk of addiction. Fentanyl, a synthetic opioid typically used to treat severe pain, is even more powerful and also carries the risk of addiction.
Beginning in the 1990s with the increasingly widespread prescription of pharmaceutical opioids, overdoses from opioid abuse have skyrocketed since. According to the Centers for Disease Control and Prevention, 220 people in America died each day from an opioid overdose in 2021, which they say is six times the number of opioid overdose deaths in 1999.
VX-548 is an oral medication that works by blocking pain signals in the peripheral nervous system, the area outside the brain and spinal cord. This makes the medication different from opioids, which act on the brain and spinal cord.
Researchers are hopeful this means the drug wouldn't carry the the same risk of addiction, if studies continue to go well and the drug is ultimately approved.
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