FDA approves the painkillers designed to eliminate risks of addiction associated with opioids

Washington (AP) – Federal officials on Thursday approved a new type of pain pill designed to eliminate the risk of addiction and overdose associated with Opioid medicine Like vicodin and Oxycontin.

The US Food and Drug Administration said that the approved Vertex Pharmaceuticals’ Journavx for short -term pain that often follows surgery or injuries.

It is the first new pharmaceutical approach to the treatment of pain in more than 20 years, offering an alternative to both opioids and medical prescription such as ibuprofen and acetaminophen. But medicine’s modest effectiveness and long -term development process emphasize the challenges of finding new ways of dealing with pain.

Studies in more than 870 patients with acute pain due to foot and abdominal operations showed Vertex’s drug more relief than a dummy pill but did not exceed a regular opioid acetaminophen combination player.

“It’s not a sludge of 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 sludge -dunk, being a very different path and mechanism of action. So I think it shows a lot of promise. “

The new drug carries a list price of $ 15.50 per Pill, which makes it many times more expensive than comparable opioids, which are often available as generic for $ 1 or less.

Vertex began to examine the fabric in the 2000s as overdoses rocket upwards, mainly driven by Lots of prescription of opioid painkillers For common disorders such as arthritis and back pain. Prescription has dropped sharply in the last decade and Current wave of opioid epidemic owed mainly Illegal Fentanyl, not pharmaceutical medicines.

Opioids reduce pain in binding to receptors in the brain that receive nerve signals from different parts of the body. These chemical interactions also give rise to Opioids’ addictive effects.

Vertex’s drug works differently and blocks proteins that trigger pain signals that are later sent to the brain.

“When trying to develop medicine that does not have the addictive risks of opioid medicine, a key factor works to block pain signaling before it comes to the brain,” Vertex’s Dr. David Althole, told Associated Press last year.

Commonly reported side effects with the drug were nausea, constipation, itching, rash and headaches.

“The new medicine has side effect profiles that are different in themselves, but does not involve the risk of drug abuse and other key side effects associated with opioids,” Dr. Charles Argoff of the Albany Medical Center, which consulted for Vertex on the development of the drug.

The original concept of focusing on pain -signaling proteins came out of research involving people with a rare hereditary condition that causes insensitivity to pain.

Vertex has attracted interest from Wall Street for its ambitious drug pipeline involving winning the FDA approval for more drugs across several forms of chronic pain, which generally represents a greater economic opportunity than acute pain.

But the Boston narcotics’ stock price declined in December when Vertex reported that disappointing midfield stadium results in a study of patients with chronic nerve pain affecting the crucifix and legs. The medicine did not impress significantly better than placebo, found research.

“We believe the data reflects an almost worst-case scenario for this central pipeline program,” said biotechnology analyst Brian Abrahams in a research note for investors, adding that the results were in danger that Vertex’s pipeline could be worth a billion across of several forms of pain.

Still, Vertex leaders said they are planning to move forward with a new, late-phase study of the drug, theorizing that another experimental design could give better results and pave the way for FDA approval in chronic pain.

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AP video journalist Mary Conlon contributed to this story from New York.

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