Categories: Business

The FDA approves the analgesics designed to eliminate the risk of dependence associated with opioids

Washington (AP) – Federal managers approved on Thursday a new type of analgesic pill designed to eliminate the risks of dependence and overdose associated with Opioid drugs like Vicodin and Oxycontin.

THE United States and Drug Administration said that he had approved the Vertex Pharmaceutical Jouravx for short -term pain that often follows surgery or injuries.

This is the first new pharmaceutical approach to treat pain in more than 20 years, offering an alternative to over -the -counter opioids and drugs such as ibuprofen and acetaminophen. But the modest effectiveness of the drug and the long development process highlight the challenges of finding new ways to manage pain.

Studies of more than 870 patients with acute pain due to abdominal and abdominal surgeries have shown that the summit medication provided more relief than a dummy pill but has not outlined a combined opioid-acetaminopian-language pill.

“It is not a slam dunk on efficiency,” said Michael Schuh of the Mayo Clinic, pharmacist and pain medicine expert who was not involved in research. “But it is a Slam Dunk in that it is a very different way and action mechanism. So, I think it shows a lot of promises. »»

The new drug will carry a list of $ 15.50 per pill, which makes it much more expensive than comparable opioids, which are often available as generics for $ 1 or less.

Vertex began to seek the medication in the 2000s, when overdoses exploded upwards, mainly caused by mass prescription of opioid pain relievers For common diseases such as arthritis and back pain. The prescriptions have dropped sharply over the past decade and Current wave of the opioid epidemic is mainly due to Illicit fentanyl, not pharmaceutical drugs.

Opioids reduce pain by linking to the brain receptors that receive nervous signals from different parts of the body. These chemical interactions also give birth to the addictive effects of opioids.

The summit medication works differently, blocking proteins that trigger pain signals which are then sent to the brain.

“By trying to develop drugs that do not have the addictive risks of opioid drugs, a key factor is to block pain signaling before it reaches the brain”, Dr. David Altshuler of Green, said to the Associated Press last year.

The side effects commonly reported with the drug were nausea, constipation, itching, rashes and headaches.

“The new drug has secondary effects that are intrinsically, not only different, but do not involve the risk of drug addiction and other key side effects associated with opioids,” said Dr. Charles Argoff of Albany Medical Center , who consulted for Vertex on the development of the drug.

The initial concept to focus on pain signaling proteins has come out of research involving people with a rare hereditary condition that causes insensitive pain.

Vertex has aroused the interest of Wall Street for its ambitious pipeline of drugs which involves gaining approval of the FDA for several drugs on several forms of chronic pain, which generally represents a greater financial opportunity than acute pain.

But the action of the Boston medication manufacturer featured in December when Vetex reported in mid-minded results in a study of patients with chronic nervous pain affecting lower back and legs. The drug did not work much better than placebo, revealed research.

“We believe that the data reflect a worse scenario of cases for this key pipeline program,” said Brian Abrahams, biotechnology analyst, in a research note to investors, adding that the results have endangered the estimates that pipeline of the summit could be worth billions on several forms of pain.

However, the leaders of Vertex declared that they plan to go ahead with a new study in the late phase of the drug, theorizing that a different test design could give better results and open the way to the ‘FDA approval in chronic pain.

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Video journalist after Mary Conlon contributed to this New York story.

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The Department of Health and Sciences of the Associated Press receives the support of the scientific and educational group of the media from the medical institute Howard Hughes and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

remon Buul

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