The FDA approves the new pain reliever which reflects the promises and challenges of opioid options

Washington (AP) – Federal authorities on Thursday approved a new type of pain designed to eliminate the risk of drug addiction and overdose associated with opioid drugs such as Wikodin and Oxicont.

The US Food and Drug Administration stated that it has approved the pellet of vertex pharmaceuticals for short -term pain, Jernvax that often follows surgery or injuries.

This is the first new drug approach to treat pain over 20 years, which offers an option for both opioid and over-the-counter drugs such as ibuprofen and acetaminophen. But the drug outlines the challenges of finding new ways to manage the drug’s minor effectiveness and long growth process.

Two studies in more than 870 patients with acute pain after legs and abdominal surgery showed that the vertex drug provided more relief than a dummy pellet, but did not perform better than a common opioid-acetaminophen combination pill.

“This is not a slam sting on effectiveness,” said Michael Shoo of Mayo Clinic, a pharmacist and pain drug specialist who was not involved in research. “But it is a slam sting that it is a very different route and mechanism of action, so I think it shows a lot of promise.”

Vertex began researching the drug in the 2000s, when drug overdose was rocketing upwards, mainly opeoid operated in large -scale painkillers for common diseases such as arthritis and back pain. Tips have fallen rapidly in the last decade and the current wave of opioid epidemics is mainly due to illegal phentineel, not due to drugs.

Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to addictive effects of opioids.

The vertex drug works in a different way, which blocks the protein that triggers pain signals that are later sent to the brain.

Dr. of Vertex David Ultshular told Associated Press last year, “In an attempt to develop drugs that do not have drug addiction to opioid drugs, a major factor is working to block pain signaling before coming to the brain. . ”

Commonly reported side effects with medication were nausea, constipation, itching, rash and headache.

Dr. of Albani Medical Center Charles Argoff said, “The new drug has side effects profiles that are not only separately, but do not include the risk of drug abuse and other major side effects associated with the opioids.” Top on the development of the drug.

The initial concept came out of research to focus on pain-compatible protein that includes people with a rare hereditary condition that causes insensitivity to pain.

Wortex has attracted interest from Wall Street for its ambitious drug pipeline including Winning FDA’s approval for many drugs in many forms of chronic pain, which usually represents a big financial opportunity than acute pain. .

But Boston drug manufacturer’s share price fell in December when vertex described the consequences of the middle phase in a study of patients with chronic nerve pain affecting the back and legs. The drug did not perform much better than Placebo, found in research.

“We believe that the data reflects the worst position landscape for this major pipeline program,” bio -technology analyst Brian Abraham said to investors in a research note, the results say that the results are in danger that vertex is in danger Many types of pain in the pipeline of the pipeline may have a value of billions.

Nevertheless, vertex officials said that they plan to move forward with a new, late phase study of the drug, saying that a separate test design can give better results and the path of FDA approval in chronic pain Can pave.

AP video journalist Mary Connalone contributed to this story of New York.

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