- Experimental drug reduces pain
- Non-addictive, blocks pain source
- Aims to replace opioids
The manufacturer claims that an experimental medication could alleviate moderate to severe pain without inducing addiction.
According to scientists in San Diego, the drug, designated VX-548, blocks pain signals at their source. This contrasts with highly addictive opioids, which alter the brain’s perception of pain.
In their Phase 3 trials involving 3,000 surgical patients, the drug alleviated acute pain just as effectively as acetaminophen—a common ingredient in paracetamol and Vicodin—did for those who received the drug.
Today, unbiased experts hailed the medication as a “blockbuster” and predicted that it could assist in reversing the opioid epidemic.
“This has the potential to be a blockbuster,” said Dr. Stephen Waxman, a neurologist at Yale who was not involved in the studies but was compensated by the company for a speaking engagement in the past.
“It’s possible that this marks the inception of non-addictive pain medications.”
Chris Raymond, an analyst at the financial firm Piper Sandler, further stated, “This medication provides an urgently required alternative to opioids.”
The medication was developed by Vertex Pharmaceuticals, which intends to apply for Food and Drug Administration (FDA) approval by June of this year.
Already granted ‘rapid track’ status, its implementation could commence as early as the following year.
A spokesperson for the company stated that it was premature to speculate on the price of the medication, but health insurance coverage was anticipated.
By inhibiting the activity of the gene NAV1.8, the drug prevents the body from producing a protein that is essential for nerves to transmit pain signals.
It affects the peripheral nervous system fibres, which are located beyond the brain and spinal cord.
Due to the drug’s action on these neurons as opposed to those in the brain, the scientists contend that the risk of addiction is significantly reduced.
Opioids, on the other hand, suppress sensations by binding to receptors in the brain and spinal cord of the central nervous system and inhibiting the release of neurotransmitters that transmit pain.
Inducing an intense high, they can also stimulate the release of feel-good hormones such as dopamine, which is associated with pleasure and reward.
Patients develop an addiction to this “high” and will pursue higher doses to reestablish it.
Additionally, they may develop tolerance to the ‘high’ over time, which may motivate them to seek out higher dosages of the substance.
The initial dose of the novel analgesic is formulated into an oral capsule containing 100 milligrams (mg) of the substance. Patients then take the medication every 12 hours for up to 14 days while taking 50 mg tablets.
Promising Results in Phase 3 Trials
Phase 3 clinical trials, which are considered the gold standard for drug approval, involved the administration of the drug, a placebo, or Vicodin, an opioid consisting of hydrocodone bitartrate and acetaminophen, to patients.
Treatment was administered to 1,118 individuals who had undergone abdominoplasties, also referred to as “tummy tucks,” and 1,073 individuals who had experienced bunionectomy, which involves the surgical removal of bony growths on the great toe.
The participants were administered the medication immediately following the operation and were instructed to document the intensity of their pain for 48 hours.
Pain was rated on a scale from one to ten, with ten denoting the most excruciating discomfort.
The findings indicated that participants who received the substance experienced a pain reduction that was statistically significant in comparison to those who received a placebo.
This improvement was comparable to that observed in patients who were administered Vicodin, a commonly prescribed opioid medication in the United States that is intended for the treatment of acute or transient pain.
However, the team argued that their drug’s lack of addictive properties rendered it preferable.
In contrast, the placebo group, which did not receive the medication, reported a reduction in discomfort that persisted for eight hours.
In the fourteen days following treatment, participants were also monitored for safety complications, of which none were reported.
At present, the prevailing choices for individuals seeking respite from moderate-to-severe pain are opioids or pharmacological agents such as ibuprofen.
Revolutionizing Pain Management Amid Opioid Crisis
Numerous physicians believe that ibuprofen is ineffective, whereas narcotics pose an addiction risk.
For the past two decades, the United States has grappled with an opioid crisis precipitated by the 1990s overprescribing of the substances, which resulted in extensive addiction.
After physicians ceased prescribing the substances, a significant number of patients turned to illicit markets or substances such as heroin and cocaine to obtain an intense high.
Users are being placed at risk by the current practice of combining these substances with fentanyl, an animal tranquilliser that, despite producing a more intense high, is lethal in tiny doses.
There is currently a record number of overdose fatalities in the United States; in August of last year, an estimated 106,000 people died from overdoses, which is a record number.
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The president of Vertex, Reshma Kewalramani, stated, “We are delighted with the VX-548 pivotal programme results, which consistently and persuasively demonstrate a synergistic blend of safety and efficacy in various acute pain settings and conditions.”
“VX-548 is in an ideal position to potentially bridge the gap between opioid medications with known risks, including addictive potential, and medicines with good tolerability but limited efficacy.”
Dr Jessica Oswald, an emergency medicine physician at the University of California, San Diego, participated in the study: “The Phase 3 safety and efficacy data from all studies are remarkable and indicate that VX-548 has the potential to revolutionise pain management.”
“I eagerly anticipate the possibility of developing a novel class of acute pain medication—the first in over two decades—to assist millions of individuals afflicted with acute pain instead of opioids.”
