The Food and Drug Administration approved a new drug on Thursday to treat pain by injury or surgery. It is expensive, with a list of $ 15.50 per pill. But unlike opioid pain medications, it cannot be addictive.
This is due to the fact that the drug, Suzetrigine, made by Vertex pharmaceuticals and sold as Journavx, only works on nerves outside the brain, preventing pain signals. Cannot get into the brain.
Researchers say they expect it to be the first of a new generation of stronger non -adaptive drugs to relieve pain.
To test the drug, Vertex, based in Boston, conducted two major clinical trials, each with about 1,000 patients with surgery pain. Were randomly assigned to take a placebo. To get the opioid sold as Vicodin, a widely used combination of medical medical pain (Tylenol) and hydrocodone. or to get Suzetrigine.
In one test, patients had a common or abdomen. In the other, they had a bunionectomy. The adverse reactions of the Suzetrigine reported by patients were similar to those reported by those who received the placebo.
The company also submitted data from a study of 250 people who evaluated the safety and tolerance of the drug in patients with pain from surgery, trauma or accidents.
Suzetrigine reduced pain as well as the combination of opioids. Both were better than the placebo to relieve pain.
The price of Suzetrigine, however, is much higher than that of acetaminophen plus hydrocodone. Patients are expected to take two pills a day for a total cost of $ 31 per day. The older drug, said Dr. John D. Loeser, pain expert at the University of Washington, is “cheap dirt” in pills per pill.
But Suzetrigine does not have unpleasant side effects of opioids such as nausea and drowsiness, and is non -activating.
“There are a lot of people who, once they have opioids, constantly want an opioid,” said Dr. Loeser.
About 85,000 people per year become addicted after receiving prescription opioids, said Dr. David Altshuler, chief scientific officer of Vertex. It is a small percentage of 40 million opioid specifications each year for acute pain – from surgery, accidents or trauma – but they are still a large number, he said.
The story of Suzetrigine began in the late 1990s with a basic research by Dr. Stephen Waxman of Yale. He was wondering how nerve cells signal pain in the brain.
Nerve cells have nine sodium channels – tiny molecular batteries – producing electrical signals.
But, he discovered, two of these channels are only active outside the brain. The one, called Nav1.7, is like security for fireworks, Dr. Waxman said. A nerve cell activates NAV1.7. This signal, in turn, activates a second channel, NAV1.8, which, he said, sends electrical signals to the brain.
It seemed that a drug that could prevent NAV1.7 or NAV1.8 could be a powerful drug for pain that would have no effect on the brain and would therefore not be addictive. (Dr. Waxman is not paid by Vertex, but is advised for other companies working on similar medicines.)
But there was another piece of the puzzle: were these laboratory results applied to humans?
If laboratory work was forecast, people with mutations made by NAV1.7 or NAV1.8 The fire would be constantly in constant pain. And people with the opposite mutation – one that blocks the channels – they should not feel pain.
Both types of mutations would be extremely rare if they existed.
Dr. Waxman came into contact with pain doctors throughout the northern hemisphere, asking if they had patients who had a steady, disobedient pain that could be caused by mutations made by NAV1.7 or NAV1.8 Overward. He came on an empty hand.
Subsequently, in 2004, the Red Red Association told him about a family in Alabama, whose members were drowned. Most had ended up being addicted to opioids and were unable to go to school or work. Their condition was called “Man on Fire Syndrome”.
Dr. Waxman and his colleagues found that members of this family had a mutation on the NAV1.7 channel that made the nerves of pain shoot constantly.
Another group of researchers said that a family in Pakistan, whose members did not feel in the pain that had a mutation that prevented the same channel from the firing. People called them firewalkers because they could walk on hot charcoal and feel nothing, something they did for money.
Vertex’s new drug, which prevents the NAV1.8 channel, is particularly specific – the other sodium channels remain alone from the drug. Suzetrigine results disappear when people stop taking the pills.
But although people with acute pain may need such a drug, there is another group that needs pain relief, but have few good choices – those who have harmed the nerves that cause constant pain, called peripheral neuropathic pain. This group includes people with diabetes who can make the hands or feet to harm or confuse, among other symptoms. And includes people with lumbar spine or bites in the spine. Sciatica is a form of this situation.
In small studies, Vertex found that Suzetrigine helped those with diabetic neuropathy, but was no better than placebo to those with spinal nerve bite.
But, said Dr. Altshuler, the company is proceeding with larger studies in both patient groups. While analysts and researchers believe that the results are frustrated in patients with nerves in their spines, the company has decided to proceed because there are no approved drugs for the painful condition and because the drug is safe and “the mechanism of action is so clearly validated.
“No one ever helped these four million people,” he said.
