New York, Feb 1 US federal officials have approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin.
The US Food and Drug Administration (FDA) said on Thursday it approved Vertex Pharmaceuticals' Journavx for short-term pain that often follows surgery or injuries, Xinhua news agency reported.
Journavx (suzetrigine) 50 milligram oral tablets, is the first drug to be approved in this new class of pain management medicines.
“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, acting director of the US FDA's Center for Drug Evaluation and Research.
“A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” Corrigan-Curay said.
Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system before pain signals reach the brain. But the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain, it noted.
Studies in more than 870 patients with acute pain due to foot and abdominal surgeries showed Vertex's drug provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill, it added.
The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood levels of creatine phosphokinase, and rash.
Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. In addition, patients should avoid food or drink containing grapefruit when taking Journavx.
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