Journavx: FDA approves the first new type of pain medicine of 25 years

Cnn
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US Food and Drug Administration signed Thursday On the first new type of pain relief that was approved for more than two decades.

The drug, Suzetrigin, is a 50-Millicram prescription pill that is taken every 12 hours after a larger starter dose. It will be sold under the branded Journal Name.

“A new non-opioid painkilling therapeutic class of acute pain allows you to mitigate certain risks associated with using an opioid for pain and gives patients a different treatment option,” Dr. Jacqueline Corrigan-curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in A news message. “This act and the agency’s designations to accelerate the development and review of the drug emphasize FDA’s obligation to approve secure and effective alternatives to opioids to pain management.”

Government Studies Show that painkillers or medications that control pain are the most commonly prescribed type of drug in hospitals.

About 80 million Americans fill each year prescription for medicine to treat new cases of moderate to severe pain, according to to a study of Vertex Pharmaceuticals, the company that developed the new drug; About half of these prescriptions are written for opioid medicine, which can lead to addiction and addiction.

Suzetrigin is the first new painkiller approved in the United States since Celebrex, a type of non-steroidal anti-inflammatory drug called a COX-2 inhibitor approved in 1998.

Several parts of the body are involved in the feeling of pain, explains Dr. Sergio Bergesse, an anesthesiologist at Stony Brook University’s Renaissance School of Medicine. Nerve cells carry an electrical signal from the site of tissue damage up to the brain, which perceives the signal as pain.

Unlike opioid medicines that throw themselves the feeling of brain pain, Suzetrigin works by preventing painful nerves around the body from shooting in the first place.

“This substance what it is doing is to interrupt that path, so even if the tissue damage exists, the brain does not,” Bergesse said.

And crucial, Suzetrigine creates no euphoria or high as opioids sometimes can, so doctors believe there is no potential for creating addiction or addiction in people who use it.

The medicine was discovered after researchers learned about a family of fire hikers in Pakistan and discovered that they were missing a gene that allowed pain signals to shoot in their skin. Members of this family could go over hot coal without flining.

“They knew they were on something hot; They knew they could feel the coal. So it does not affect the nerves that heat and touch and the like. It’s just these pain -nervous nerves, ”said Stuart Arbuckle, CEO of Vertex Pharmaceuticals. “They were in any other way normal.”

Still, scientists took 25 years to find out how to take advantage of the pain -driving mechanism to develop a medicine.

“Neurons talk to each other by producing series of nerve impulses, like a mother code,” Dr. Stephen Waxman, who heads the Center for Neuroscience and Regeneration Research at the Yale School of Medicine. ”And nerve impulses are produced by small molecular batteries in the membranes of neurons. The molecular batteries are called sodium channels. ”

Suzetrigin works by closing a sodium channel that performs only pain signals.

There have been many fake starts along the way to find a drug that could block a particular sodium channel. Suzetrigine’s approval means that other drugs that could work even better are likely to follow, Waxman said.

“It is an important step forward because it provides evidence of the concept that a (sodium channel blocks) can reduce pain in humans,” said Waxman, who has no financial ties to the new drug. “It opens the door to another generation of even more effective (medicine).”

Suzetrigin is a pill that is given in two doses. In studies, participants received an initial dose of 100 milligrams, followed by 50 milligrams every 12 hours.

Doctors emphasize that it may not be the right substance for everyone or for any type of pain.

In two Clinical trials It included nearly 600 participants, Suzetrigin controlled pain after abdominal and foot surgery better than an inactive placebo pill. Around so many people said Suzetrigin reduced their pain by at least half after surgery like those who took vicodin, which is a combination of acetaminophen and opioid hydrocodone. The research was not designed to directly compare Suzetrigin with Vicodin, so it’s hard to know if one worked better than the other.

In a well -known assessment scale that runs from 0 to 10, the study participants started with pain of about seven on average, and Suzetrigin reduced it approx. 3.5 points.

“It’s not like removing all pain,” Arbuckle said. “It reduces pain by approx. 50%. ”

In one Third studyOf people who had back pain caused by sciatica, Suzetrigine reduced pain by approx. 2 points, the same amount reported by people who took a placebo, which suggests that this drug may not be a prominence for chronic pain.

Vertex disagrees and says it has tested the drug in different types of chronic pain and that it seems to work for prolonged pain. The company continues to test it in people who have diabetic neuropathy, where high blood sugar levels damage nerves over time, leading to symptoms such as numbness, tingling, pain and muscle weakness.

The Isiah survey was smaller than the others, with about 100 people in the Suzetrigin arm and in the placebo group, so there may have been enough participants to show clear differences between the groups. Placebos tend to have major effects in pain studies as well, which complicates their interpretation.

“In our opinion, the drug did what we expected to do with regard to the amount of pain relief,” Arbuckle said. “But unfortunately, which often happens in studies in pain, there is quite a large placebo response.”

Doctors who help people manage pain said they were happy to have a new opportunity.

“The more options we have, the better we are able to treat every single patient,” said Dr. Kimberley Mauer, an anesthesiologist at Oregon Health and Science University.

Mauer said that costs can be a big factor in how the drug is used. Vertex said it has set a wholesale cost of $ 15.50 per day. 50 mg pill but that patient help programs would be available.

Mauer said doctors and patients should wait to learn what insurance companies can do in terms of coverage.

“It may limit some patients who get it. So we just have to see, and it’s hard to see until it’s coming out of the market, ”she said.