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

Food and Drug Administration approved a new medicine on Thursday to treat pain from an injury or surgery. It is expensive with a list price of $ 15.50 per Pill. But unlike medicine opioid pain, it cannot become addictive.

This is because the drug, Suzetrigin, made from Vertex Pharmaceuticals and being sold as a Journal, only works on nerves outside the brain and blocks pain signals. It can’t get into the brain.

Scientists say they expect it to be the first of a new generation of more powerful non -addictive drugs to relieve pain.

In order to test the drug two large clinical trialsEach with approx. 1,000 patients who had pain in surgery. They were randomly assigned to get a placebo; To get the opioid sold as vicodin, a widely used combination pain medicine of acetaminophen (tylenol) and hydrocodone; or to get suzetrigin.

In one experiment, patients had an abdominoplasty or stomach upholstery. In the other they had a bunionectomy. Side effects of Suzetrigin reported by patients responded to those reported by those who took placebo.

The company also submitted data from a 250-person study that assessed the safety and tolerability of the drug in patients with pain from surgery, trauma or accidents.

Suzetrigin relieved pain as much as the combination opioid. Both were better than placebo to relieve pain.

However, Suzetrigine’s price is much higher than for acetaminophen plus hydrocodone. Patients are expected to take two pills a day at a total cost of $ 31 a day. The older drug said Dr. John D. Loser, an emeritus Pain expert at the University of Washington, is “Dirt cheap” by ear per. Pill.

But Suzetrigin does not have Opioid’s unpleasant side effects such as nausea and drowsiness, and it is not -Addictive.

“There are a number of people who, once they have an opioid, constantly want an opioid,” Dr. Loeser.

About 85,000 people a year become addicted after taking a prescription opioid, Dr. David Althole, Chief Scientific Officer in Vertex. That’s a small part of the 40 million prescribed opioids every year for acute pain – from surgery, accidents or trauma – but is nonetheless a large number, he said.

The story of Suzetrigin began in the late 1990s with basic research By Dr. Stephen Waxman from Yale. He wondered how nerve cells signalize pain to the brain.

Nerve cells have nine sodium channels – small molecular batteries – that generate electrical signals.

But, he discovered, two of these channels are only active outside the brain. One, called NAV1.7, is like the fuse For a fireworks, Dr. Waxman. A nerve cell activates NAV1.7. This signal activates on its side one Second Channel, NAV1.8Like, he said, sends electrical signals about pain to the brain.

It seemed that a drug that could block NAV1.7 or NAV1.8 could be a potent pain medication that would have no effects on the brain and therefore would not be addictive. (Dr. Waxman is not paid by Vertex but consults for other companies working with similar drugs.)

But there was another piece of the puzzle: Were these laboratory results useful to humans?

If the laboratory work was predictable, people with mutations that did NAV1.7 or NAV1.8 fire would constantly have constant pain. And people with the opposite mutation – someone who blocked the channels – should feel no pain.

Both kinds of mutations would be extremely rare if they existed.

Dr. Waxman contacted pain doctors across the entire Northern Hemisphere and asked if they had patients who had constant, indispensable pain that could be caused by mutations that made NAV1.7 or NAV1.8 overactive. He came up empty.

Then, in 2004, the Erythromelalgia Association told him about a family in Alabama whose members were wrapped with pain. Most people had ended up being dependent on opioids and were unable to go to school or work. Their condition was called “man on four syndrome.”

Dr. Waxman and his colleagues found that the members of this family had one Mutation in NAV1.7 Channel that caused their pain nerves to shoot constantly.

Another group of researchers reported that a family in Pakistan whose members Felt no pain Had a mutation that blocked the same channel from firing. People called them firewalkers because they could go on hot coal and feel nothing, which they did for money.

Vertex’s new drug that blocks the NAV1.8 channel is very specific – the other sodium channels are left alone by the drug. Suzetrigine’s effects disappear when people stop taking the pills.

But even though people with acute pain may need such a drug, there is also another group that needs pain relief but has few good options – those who have damaged nerves that cause constant pain, called peripheral neuropathic pain. This group includes people with diabetes who can hurt their hands or feet or become numb, among other symptoms. And it includes people with lumbosacral radiculopathy or squeezed nerves in the spine. Isias is a form of this condition.

In small studies, Vertex found that Suzetrigin helped them with diabetic neuropathy, but was no better than placebo in those with squeezed spinal cord nerves.

But, said Dr. Althole, the company goes on with larger studies in both groups of patients. While analysts and researchers evaluated the results disappointing in patients with squeezed nerves in their spines, the company decided to continue because there are no approved drugs for the painful state and because the drug is safe and “The action mechanism is so clearly validated. “

“No one has ever helped these four million people,” he said.