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FDA has granted a new type of pain pill designed to remove the risk of addiction and overdose associated with opioid drugs such as Vicodin and OxycontinFirst of its kind in 20 years.
New medicine, called journalavx, no-opioid Licelak against pain is designed for short-term pain after surgery or injury.
It is the first new pharmaceutical approach to the treatment of pain in more than 20 years, offering an alternative and opioids and drugs with countermandoms such as ibuprofen and acetaminophen.
However, modest drug efficiency and long-term development process underline the challenges of finding new pain management modes.
The new medicine will also carry the price list of $ 15.50 per pill, which is more expensive than comparable opioids, often available for 1 or less pounds.
Studies in more than 870 patients with acute pain and abdominal operations have shown that Vertex drug provided more relief from doll tablets, but did not outweigh a combination of opioid-acetaminophen.
“It is not a slam dunking effectiveness,” said Michael Schuh from Clinika Mayo, Pharmacist and painkillery that was not involved in research. “But it’s a slam dunking in that it is a very different path and the action mechanism. So I think it shows a lot of promises.”
Vertex began to explore the drug in 2000s, when the overdosets are rocketed upwards, mainly guided by a mass by prescribing opioid painkillers for joint diseases such as arthritis and back pain. The transcripts fell sharply in the last decade, and the current wave of opioid epidemics is mainly due to illegal fentanila, not drugs for pharmacist.
However, almost 10 percent of patients with acute pain in the U.S., continued by long-term use, and 85,000 continued to develop the use of opioids a year, Vertex said in the statement, according to the statement, according to CNBC.
Opioids reduce pain by binding for receptors in the brain receiving nervous signals from different parts of the body. These chemical interactions also give rise to the addictive effects of opioid.
Vertex drug acts differently, blocking proteins that run pain signals that have been later sent to the brain.
“In an attempt to develop drugs that do not have addictive risks, the key factor is working to block pain signaling before it occurs,” Vertex Dr. David Altshuler said in the associated journalist last year.
The most commonly reported drug side effects were nausea, prison, itching, rash and headache.
“The new drug has side effects that are inherent, not only different, but do not involve the risk of substance abuse and other key side effects associated with opioids,” said Dr. Charles Argoff from the Albany Medical Center, who advised Vertex on the development of the drug.
The initial concept for focusing on pain signaling has gone out of research involving people of a rarely hereditary condition that causes impassibility to pain.
Vertex attracted interest from Wall Street for its ambitious drug pipeline that includes a victory for FDA approval for multiple medications in several forms of chronic pain, which generally represents a higher financial opportunity.
But the price of the Boston’s share in December fell in December when Vertex reported that the disappointing medium phase results in a patient studios with chronic nerve pain that affect the lower back and legs. The drug did not perform significantly better than placebo, the research found.
“We believe that the data reflects near the worst scenario for this key pipeline,” Brian Abrahams Biotechnology Analyst, adding that the results would endanger the estimate of Vertex pipeline in multiple forms of pain.
Still, Vertex managers said they were planning to move forward with a new, late study of drugs, theorization that a different trial design could give better results and queries the path to the FDA approval in chronic pain.
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Additional reporting from the AP.