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The FDA has confirmed a new type of pain pill that is the first type of its type in 20 years to eliminate the risks of addiction and overdose related to opiate drugs such as Vicodine and Oxy Contian.
The new drug called Journavx is a non -opium painkiller designed for short -term pain after surgery or injuries.
This is the first new drug for the treatment of pain in more than 20 years to provide replacement for opioid substances and non -prescription drugs such as ibuprofen and acetaminophen.
However, the average effectiveness of the drug and the long development process emphasizes the challenges of finding new ways to manage pain.
The new drug also priced at $ 15.50 per tablet, which is more expensive than opiates, often available at 1 or less.
Studies in more than 870 patients with acute pain due to foot and abdominal surgery have shown that the drug was relieved of the fabricated tablet but did not work better than a combination of opiate-acetaminophen.
“This is not a drowning of effectiveness,” said Michael Shu of a Mayo clinic, a painter and pain medical expert who did not participate in the study. “But it is an Islamic immersion that is a very different path and mechanism of action. So, I think it shows many promises.”
In the 2000s, Vertex began research into the drug, when over -use was over -the -rocket, mainly by massively prescribed opioid painkillers for common diseases such as arthritis and low back pain. The versions have declined sharply over the past decade, and the current wave of opiatemate is mainly due to illegal fentanyl, not drugs.
However, approximately 10 % of the patient with acute pain treated in the United States with opiates make prolonged use, while 85,000 still causes opiates annually.
Effects reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. These chemical interactions also create addictive effects of opiates.
Vertex works differently and blocks the proteins that cause pain signals that are later sent to the brain.
“In trying to create drugs that do not have the addictive risks of opioid drugs, a major factor is trying to block pain signaling before it gets into the brain,” said Dr. David Alchuler, Vertex last year.
The reported side effects were usually nausea, constipation, itching, rash and headache.
“The new drug has a profile of side effects that are inherently different, but also the risk of substance abuse and other main side effects associated with opiates. . ” Ross about drug development.
The basic concept of focusing on pain signaling proteins came out of research on people with a rare hereditary disease that causes the pain to be allergic.
Vertex has attracted Wall Street interest because of its ambitious pipeline, which includes winning FDA approval for multiple medications in various types of chronic pain, which generally indicates a greater financial opportunity than acute pain. .
But the price of Boston’s pharmacist declined in December, with Vertex reporting the disappointing results in the study of patients with chronic neurological pain that affects the lower back and legs. The research showed that the drug was not significantly better than placebo.
“We believe that the data represents an almost worst scenario for this main pipeline program,” said Biotechnology analyst.
However, Vertex managers said they intend to move forward with a new study at the end of the drug, to make theorizing that a different experimental plan can have better results and the way to confirm FDA in the FDA. Chronic pain smooth.
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Additional report by AP.
