Washington – Federal officials approved Thursday a new type of pain in pain designed to eliminate the risk of dependence and overdose associated with opioid Medicines like Vicodin and Oxycontin.
The Food and Drug Administration of the United States said it had approved the Vertex Pharmaceuticals, Jouravx pill, 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.
Vertex Pharmaceuticals via AP
Two studies on more than 870 patients with acute pain after foot and abdomen surgeries have shown that the summit medication provided more relief than a dummy pill but has not outlined a combined opioid-acetaminopenopène pill common.
“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 path and action mechanism, so I think that shows a lot of promises.”
Vertex began to seek the medication in the 2000s, when drug overdoses exploded upwards, mainly driven by the 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 the current wave of the opioid epidemic is mainly due to Fentanyl illegalNo 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 work to block pain signaling before it reaches the brain,” David Altshuler said Vertex at 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 effect profiles which are intrinsically not only different, but do not imply the risk of drug addiction and other key side effects associated with opioids,” said Dr. Charles Argoff of Albany Medical Center, who consulted the summit of the summit 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 course of the action of Boston’s drug manufacturer fell in December when Vertex reported in mid-term results in a study of patients with chronic nervous pain affecting the 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.