Surgery can be uncomfortable, some more than others. Most patients find themselves suffering not always because of pain but because of the opioids they were given as part of their procedure. Now, non-opioid options have proven effective for acute surgical and non-surgical pain, limiting undesired side effects and, of course, the danger of opioid addiction.
The Development of a Non-Opioid Drug
The development of non-opioid analgesics has become an even more urgent need with the never-ending opioid crisis leading to overdoses and deaths. Now in a series of Phase 3 clinical trials, an oral, non-opioid painkiller has proven effective in treating acute pain.
- The drug is presently called VX-458.
- It is being tested by Vertex Pharmaceuticals Inc.
- Trials found the drug to effectively treat moderate to severe acute pain.
- The medication works under both surgical and non-surgical conditions.
Many anesthesiologists rely on the power of fentanyl as a powerful and reliable part of general anesthesia. Many patients want nothing to do with this highly addictive substance. The development of more non-opioids like VX-458 can free patients from limitations and worries about certain potent drugs during surgery and pain relievers after a surgery.
Clinical Trials of a Non-Opioid Medication
In the trials for VX-458, patients underwent a tummy tuck or bunion removal and the drug was administered after the procedures. The goal was to gather statistically significant evidence showing the effectiveness and safety of the non-opioid so that marketing approval could be granted by regulatory authorities.
Abdominoplasty was selected because it is a model of soft-tissue pain and the bunionectomy an example of bone pain. In both procedures, patients were given one of three things: oral doses of VX-458, a combo of hydrocodone and Vicodin, or a placebo. The meds were administered over 48 hours at relatively comparable doses.
After over 1,100 tummy tucks and over 1,000 bunion removals, statistically significant pain relief was observed from the non-opioid versus the placebo, plus it worked faster. VX-458 was not determined as able to provide superior pain relief compared to the hydrocodone/Vicodin combo.
Expanding the Testing for a Non-Opioid Medication
The clinical trials for VX-458 expanded to include patients who had undergone orthopedic, urologic, plastic, and general surgery, as well as non-surgical patients with different types of pain. Just over 83% of the patients rated the drug as “good,” “very good,” or “excellent” at treating pain.
No major adverse events were reported after the use of VX-458 and the drug was found to be safe and well-tolerated. The drug company is eager to champion their new development and potentially fill the gap with a medication that is well-tolerated and free from the known risks of opioids, particularly addictive potential.”
Vertex plans to submit a New Drug Application to the FDA by the middle of this year, asking for approval to treat moderate to severe acute pain. They are eager to fast track the drug and get it into the hands of doctors who can tend to patients who suffer from acute pain every year.
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