The American Food and Drug Administration (FDA) approved Suzetriga, a new non -porosity analgesic drug sold under the JournaVX brand, in order to treat moderate to severe acute acute pain in adults.
Journavx with Vertex Pharmaceuticals means the first new class of painkillers that received FDA consent in over two decades. It will be sold as 50 milligram prescription tablets, which work by blocking the pain signals in their source by aiming at sodium channels in the nervous system and stopping the pain before it reaches the brain.
“Today’s approval is an important milestone of public health in the field of acute pain treatment. The new non -porosity therapeutic class for acute pain offers the possibility of limiting some threats associated with the use of pain opioids and provides patients with a different treatment option. This action and markings of the agency in order to accelerate the development and review of the drug emphasize the involvement of the FDA in the approval of safe and effective alternatives for painting opioids, “said Dr. Jacqueline Corrigan-Curay, acting as director press release.
A non -porosity relief in pain is a key step forward in solving the ongoing opioid crisis. With over 80 million Americans requiring a relief in pain, about half are prescribed opioids. However, almost 10% of people initially prescribed opioids end them in long -term, and about 85,000 develops the use of opioids each year. Alternatives without opioids are a safer option for pain treatment, reducing the risk of dependence.
According to producerJournavx is a well -tolerated, effective painkiller without signs of addictive potential, designed for all types of moderate or severe acute pain.
The effectiveness of the drug was studied in two clinical studies on surgical pain, one after Tuck (belly) surgery, and the other after tumor surgery. Participants received Journavx or Placebo randomly. If pain control was not sufficient, they could also take ibuprofen for an additional relief. Both attempts showed that Journavx was working much better than placebo in reducing pain.
Journavx security was assessed on the basis of data from two main studies with 874 participants who had moderate to severe pain after abdominal surgery or tumor surgery, along with additional data from smaller tests with 256 participants in various acute pain.
The most common reported side effects were itching, muscle spasms, increased level of creatine phosphocinase and rash. Journavx should not be taken with strong CYP3A inhibitors, and patients should avoid food and beverages containing grapefruit or grapefruit. The drug will be priced at USD 15.50 for 50 mg pills.