Washington – Federal officials on Thursday adopted a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medicines such as Vicodin and Oxycontin.
The US Food and Drug Administration said it approved Vertex Pharmaceuticals magazine for short -term pain that often follows surgery or damage.
It is the first new pharmaceutical approach to treat pain in more than 20 years, offering an alternative to both opioids and prescription medicines such as ibuprofen and acetaminophen. But the modest effectiveness of medicines and the long development process underline the challenges of finding new ways to manage pain.
Studies in more than 870 patients with acute pain due to foot and abdominal surgery showed the vertex drug provided more relief than a kitchen pill, but did not overcome a combined opioid-acetaminophen pill.
“There is a dunk collided in effectiveness,” said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research. “But it’s a dunk slammed into what is a very different path and mechanism of action. So, I think it shows a lot of promises.”
The new medicine will have a $ 15.50 list price per pill, making it many times more expensive than comparable opioids, which are often available as generics for $ 1 or less.
Vertex began to research the drug in the 2000s, when overdoses were rising up, mainly driven by the description of opioid sedatives for common diseases such as arthritis and back pain. The recipes have fallen sharply in the last decade and the current wave of opioid epidemics is largely due to illegal fenthanine, not pharmaceutical drugs.
Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. These chemical interactions also cause opioid -dependent effects.
The vertex drug works differently, blocking the proteins that cause pain signals that are later sent to the brain.
“In trying to develop medicines that do not have the addictive risks of opioid drugs, a major factor is working to block the pain signal before it reaches the brain,” said Dr. David Altshuler vertex, for the Associated Press last year.
The side effects usually reported with the medicine were nausea, constipation, itching, redness and headaches.
“The new drug has profiles of side effects that are naturally, not only different, but do not include the risk of abuse of substances and other main side effects associated with opioids,” said Dr. Charles Argoff of the Albany Medical Center, which advised vertex on drug development.
The initial concept of focusing on pain signal proteins emerged from research involving people with a rare hereditary state that causes painful pain.
Vertex has attracted interest from Wall Street for his ambitious drug pipeline that involves acquiring the approval of FDA for numerous medicines in some forms of chronic pain, which generally represents a greater financial opportunity than acute pain.
But the price of Boston Drugmaker’s action decreased in December when Vertex reported the disappointment of the middle phase results in a study of patients with chronic nerve pain affecting the lower back and legs. The drug did not perform significantly better than the placebo, the research found.
“We believe the data reflects a near -worse scenario for this leading pipeline program,” said Biotechnology analyst Brian Abraham in a research note for investors, adding that the results endangered estimates that the vertex can be worth billions in forms numerous pain.
However, vertex leaders said they plan to move forward with a new study, in the late stage of the drug, theorizing that a different trial model could give better results and pave the way for FDA approval in pain chronic.
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