FDA approves Vertex’s non-opioid painkiller, first new kind of pain medicine in decades


 

The Food and Drug Administration on  King88bet Login   Thursday approved Vertex Pharmaceuticals' non-opioid painkiller pill, a new alternatif for pain relief that comes without the risk of addiction.


Vertex is now the first drugmaker in decades to gain U.S. approval for a new tipe of pain medicine. It's a milestone after a long history of mostly unsuccessful usahas to develop painkillers without the destructive dependency of cheap and widely available opioids, which have caused a horrific pandemic of abuse and overdose in the U.S.


Vertex's drug, Journavx, is specifically   King88bet Slot    approved for the treatment of moderate to severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely eases with time. Around 80 million patients are prescribed a medicine for their moderate to severe acute pain every year in the U.S., according to Vertex.


Almost 10% of patients with acute pain who are treated initially with an opioid will go on to have prolonged opioid use, and roughly 85,000 people will develop opioid use disorder annually, Vertex said in a pernyataan.


"We have the opportunity to change the paradigm of acute pain manajemen and establish a new standar of peduli," Dr. Reshma Kewalramani, Vertex CEO, said in a pernyataan.


Vertex said Journavx will have a daftar King88bet Terpercaya   price of $15.50 per 50-milligram pill. Wall Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion.


The pengalaman of pain starts in a nerve ending, and the bodi detects the pressure and sends a sinyal to the spinal cord and then the brain. Vertex's treatment works by blocking pain signals at their origin before they reach the brain. That's different from opioids, which act directly on the brain to blok pain, triggering the brain's rewards centers in a way that can feed addiction.


The approval underscores the "FDA's commitment to approving safe and efekive alternatifs to opioids for pain manajemen," said Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research, in a release.


Vertex's painkiller was more efekive than a placebo at reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as "tummy tucks," and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.


The painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared with a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the pangkalan for populer pain medications such as Tylenol.

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