A cypher hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston.
Brian Snyder | Reuters
The Food and Drug Distribution on Thursday approved Vertex Pharmaceuticals’ non-opioid painkiller pill, a new alternative for pain relief that comes without the hazard of addiction.
Vertex is now the first drugmaker in decades to gain U.S. approval for a new type of pain medicine. It’s a milestone after a hanker history of mostly unsuccessful efforts to develop painkillers without the destructive dependency of cheap and widely available opioids, which must caused a horrific epidemic of abuse and overdose in the U.S.
Vertex’s drug, Journavx, is specifically approved for the treatment of moderate-to-severe alert pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely quiets with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., be consistent to Vertex.
Almost 10% of patients with acute pain who are treated initially with an opioid will go on to would rather prolonged opioid use, and roughly 85,000 people will develop opioid use disorder annually, Vertex said in a expression.
“We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” Dr. Reshma Kewalramani, Pinnacle CEO, said in a statement.
Vertex said Journavx will have a list price of $15.50 per 50-milligram pill. Brick up Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could top $1 billion.
The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal string and then the brain. Vertex’s treatment works by blocking pain signals at their origin before they reach the capacity. That’s different from opioids, which act directly on the brain to block pain, triggering the brain’s rewards centers in a way that can eat addiction.
The approval underscores the “FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, acting number one of the FDA’s Center for Drug Evaluation and Research, in a release.
Vertex’s painkiller was more effective than placebo at reducing the zeal of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also conscious as “tummy tucks,” and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in swots of people with acute pain.
The painkiller, however, failed to meet the secondary goal in both trials of pulp pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for conventional pain medications such as Tylenol.
In both trials, rates of adverse side effects were lower in those who suffered Vertex’s drug compared to people who took a placebo. The most commonly reported adverse events among being who received Journavx were itching, muscle spasms and rash, among others, according to the FDA.
In a separate phase three deliberate over, more than 83% of patients said in a survey that the drug was good, very good or excellent at allaying pain. Those people had undergone various surgical or non-surgical procedures.
The bigger opportunity for Vertex may be to win FDA approval in long-lived pain. That’s an area where the risk of addiction to prescription opioids can be greater, according to the Centers for Disease Master and Prevention.
In 2023, the company’s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a persistent nerve condition.