The FDA approves Journavx for the treatment of pain without the risk of addiction

On Thursday, Food and Drug Administration approved a modern drug for the treatment of pain due to injury or surgery. It is steep, with a catalog price of USD 15.50 per pill. But unlike opioid painkillers, it cannot become addictive.

This is due to the fact that Suzetrigine, produced by Vertex Pharmaceuticals and sold as Journavx, works only on nerves outside the brain, blocking pain signals. He can’t get to the brain.

Scientists say that they expect it to be the first modern generation of stronger non -administrative drugs to alleviate pain.

To test the medicine, Vertex, based in Boston, carried out Two large clinical trialsEach of about 1000 patients who felt pain after surgery. They were randomly assigned to get placebo; To obtain sold opioids as a Vicodin, widely used combined painkillers of acetaminofen (Tythenol) and hydrocodone; or get suzetriga.

In one study, patients had abdominal and stomach tuc. On the other hand, they had Gunitomia. Suzetrigin side effects reported by patients were similar to those reported by Placebo persons.

The company also submitted data from a 250-person study, which assessed the safety and tolerance of the drug in patients with pain after surgery, injury or accidents.

Suzetrigina softened the pain in the same way as a combined opioid. Both were better than placebo because of soothing pain.

The price of Suzetrigine, however, is much higher than in the case of acetaminofen plus hydrocodone. Patients are expected to take two tablets a day for the total cost of USD 31 per day. Elderly, said Dr. John D. Loeser, a retired expert at the University of Washington, is “affordable” in pennies for a pill.

But Suzetrigina has no unpleasant side effects of opioids, such as nausea and drowsiness, and is unable.

“There are many people who want opioid after their opioid,” said Dr. Loeser.

Dr David Altshuler, the main scientific officer in Vertex, about 85,000 people become addicted after taking prescription opioids. He said that this is a compact part of 40 million prescribed opioids due to acute pain – from surgery, accidents or injuries – but there is a huge number, he said.

The history of Suzetrigine began in the delayed 1990s tests Dr. Stephen Waxman from Yale. He wondered how nerve cells signal brain pain.

Nine cells have nine sodium channels – compact molecular batteries – which produce electrical signals.

But, he discovered, two of these channels are lively only outside the brain. One called NAV1.7, it’s like a fuse Dr. Waxman said for firecrackers. The nerve cell activates NAV1.7. This signal, in turn, activates Second channel, NAV1.8who, he said, sends pain signals to the brain.

It seemed that the drug that could block NAV1.7 or NAV1.8 could be a powerful analgesic drug that would not affect the brain, and therefore would not be addictive. (Dr. Waxman is not paid by Vertex, but consult with other companies working on similar drugs).

But there was another piece of the puzzle: do these laboratory results apply to people?

If laboratory work were predictive, people with mutations who became the fire of NAV1.7 or NAV1.8 would constantly have constant pain. And people with a reverse mutation – one that blocked the channels – should not feel pain.

Both types of mutations would be extremely infrequent if they existed.

Dr. Waxman contacted the doctors of pain in the entire northern hemisphere, asking if they had patients who had a indefinite, tough to solve pain, which could be caused by mutations, which made NAV1.7 or NAV1.8 overactive. He left empty -handed.

Then, in 2004, the ERYTROMELALGIA Association told him about a family in Alabama, whose members were grabbed with pain. Most became addicted to opioids and were unable to go to school or work. Their state was called “a human team on fire.”

Dr. Waxman and his colleagues discovered that members of this family had Mutation in NAV1.7 A channel that constantly became pain nerves.

Another group of researchers announced that the family in Pakistan, whose members he didn’t feel pain He had a mutation that blocked the same channel before shooting. People called them fireworks because they could walk on sizzling coals and feel nothing they did for the money.

The modern Vertex drug that blocks the NAV1.8 channel is highly specific – the other sodium channels are left alone by the drug. Suzetrigine effects disappear when people stop taking tablets.

But although people with acute pain may need such a medicine, there is another group that requires a relief in pain, but has little good options – those who damaged the nerves that cause constant pain, called peripheral neuropathic pain. This group includes people with diabetes who can make their hands or feet hurt or numb, among others with symptoms. And it includes people with lumbulvoa radiculopathy or a pinned nerves in the spine. Smycka is one form of this state.

In compact studies, Vertex stated that Suzetrigina helped people with diabetic neuropathy, but it was not better than placebo in people with gaping the nerves of the spine.

But Dr. Altshuler said that the company continues more research in both groups of patients. While analysts and researchers recognized the results disappointing in patients with pinched nerves in their spikes, the company decided to continue because there are no approved drugs for a painful condition, and also because the drug is sheltered and “the mechanism of action is so clearly approved. “

“Nobody has ever helped four million people,” he said.