An experimental drug could relieve moderate to severe pain without causing addiction, the company behind it says.
Scientists in San Diego say the drug – called VX-548 – works by cutting off pain signals at the source, unlike highly addictive opioids that can act on the brain’s perception of pain.
In their Phase 3 studies involving 3,000 surgical patients, results showed that acute pain was relieved in recipients of the drug as effectively as in those given acetaminophen – commonly used in medications such as Paracetamols and Vicodin.
Independent experts today called the drug a “blockbuster” and said it could help turn the tide of the opioid crisis.
Scientists in San Diego say the drug – called VX-548 – works by cutting off pain signals at the source and does not affect the brain, preventing addiction (stock image)
The graph above shows the pain participants reported up to 48 hours after receiving the drug. The black line represents people who received a fake drug or a placebo, while the brown line represents those who received Vicodin and the light blue line represents those who received VX-548.
Dr. Stephen Waxman, a neurologist at Yale who was not involved in the studies but was previously paid by the company for a speaking engagement, said: ‘This has the potential to be a blockbuster.
“I like to think this is the beginning of non-addictive pain medications.”
Chris Raymond, an analyst at financial firm Piper Sandler, added: “This drug definitely provides an alternative (to opioids) that is desperately needed.”
Vertex Pharmaceuticals, which developed the drug, plans to apply for approval from the Food and Drug Administration (FDA) by June this year.
It has already been given the ‘fast track’ designation, meaning it could be rolled out as early as next year.
A company spokeswoman said it was too early to say how much the drug would cost, although it was expected to be covered by health insurance.
The drug works by blocking the activity of a gene called NAV1.8, which prevents the body from making a protein needed for the nerves to transmit pain signals.
It acts on the nerves in the peripheral nervous system, or on the nerves outside the brain and spinal cord.
The scientists claim that because the drug acts on these nerves, rather than those in the brain, there is a much lower risk of addiction.
By comparison, opioids work by binding to receptors in the central nervous system (brain and spinal cord) and inhibiting the release of neurotransmitters that transmit pain to numb the feelings.
They can also stimulate the production of feel-good hormones such as dopamine, which is associated with pleasure and reward, creating an intense high.
Patients become addicted to this ‘high’ and will seek more doses to achieve it again.
Over time, they may also develop a tolerance to the “high,” leading them to seek out stronger doses of the drug.
The new painkiller is administered as a oral pill containing 100 milligrams (mg) of the drug as the first dose. Patients then take 50 mg pills of the drug every 12 hours for up to 14 days.
In the Phase 3 clinical trials, the gold standard for approving a drug, patients were given the drug, a placebo, or Vicodin – an opioid containing the drugs hydrocodone bitartrate and acetaminophen.
A total of 1,118 people were treated after a tummy tuck – a cosmetic procedure also known as a ‘tummy tuck’ – while 1,073 people were treated after a bunionectomy – or surgery to remove bunions, bony growths on the big toe.
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They were given the drug shortly after surgery and asked to report the pain they felt for up to 48 hours.
Pain was reported on a scale of one to ten, with 10 indicating the most severe pain.
The results showed that there was a statistically significant reduction in pain in participants after receiving the drug compared to those who received a placebo.
This improvement was no greater than in patients receiving Vicodin, one of the most commonly prescribed opioids in the US used to treat acute or short-term pain.
But the team said the fact that their drug was not addictive made it superior.
By comparison, the placebo group – which did not receive the drug – said their pain only decreased after eight hours.
Participants were also monitored for safety complications for up to 14 days after treatment, although none were reported.
Currently, most people seeking relief from moderate to severe pain have two options: medications such as ibuprofen or opioids.
Many doctors suggest that ibuprofen is not very effective, while opioids put a person at risk for addiction.
The graph above shows the estimated number of overdose deaths due to opioids over a twelve-month period
America has been grappling with an opioid crisis for two decades, with overprescribing of the drugs in the 1990s leading to widespread addiction.
When doctors finally stopped writing prescriptions for the drugs, many turned to the black market and drugs like heroin and cocaine to get an intense high.
These drugs are now being mixed with fentanyl – an animal tranquilizer that can provide a more intense high but is fatal in very small doses – putting users at risk.
The US is currently recording a record number of overdose deaths, with an estimated 106,000 people dying from an overdose in August last year – a record.
Reshma Kewalramani, president of Vertex, said: “We are very pleased with the results of the VX-548 pivotal program, which demonstrates a compelling and consistent combination of efficacy and safety in multiple acute pain conditions and settings.
“VX-548 is ideally positioned to potentially bridge the gap between drugs that are well tolerated but have limited efficacy, and opioid drugs with therapeutic efficacy but known risks, including addictive potential.”
Dr. Jessica Oswald, an emergency room physician at the University of California, San Diego, who was involved in the study, said: ‘The Phase 3 safety and efficacy data from the studies are impressive and demonstrate the potential of VX-548 to change the paradigm of the disease. pain management.
“I look forward to the potential of a new class of acute pain medications – the first in more than two decades – that could be used as an alternative to opioids to help millions of people affected by acute pain.”
Vertex Pharmaceuticals says it now also wants to develop a new painkiller for people suffering from chronic or long-term pain signals.