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The US Food and Drug Administration signed Thursday On the first new type of pain reliever to be approved in more than two decades.
The medication, Suzetrigine, is a prescription pill of 50 milligrams which is taken every 12 hours after a larger start -up dose. It will be sold under the daily brand.
“A new non-opioid analgesic therapeutic class for acute pain offers the possibility of mitigating certain risks associated with the use of an opioid for pain and offers patients another treatment option,” said Dr Jacqueline Corrigan- Curay, interim director of the FDA FDA Evaluation and Research FDA Medicines, said in a press release. “This action and the appointment of the agency to accelerate the development and examination of the drug underline the commitment of the FDA to approve of safe and effective alternatives to opioids for pain management.”
Government surveys show that pain relievers, or drugs that control pain, are the most commonly prescribed drug in hospitals.
According to a study by Vertex Pharmaceuticals, the company that has developed a new drug; About half of these prescriptions are written for opioid drugs, which can lead to dependence and dependence.
Suzetrigin is the first new analgesic approved in the United States since Celebrex, a type of non-steroidal anti-inflammatory drug called COX-2 inhibitor, which was approved in 1998.
Several parts of the body are involved in the feeling of pain, explains Dr. Sergio Bergese, anesthesiologist at the Renaissance School of Medicine of the University of Stony Brook. The nerve cells carry an electrical signal from the tissue damage site to the brain, which perceives the signal as a pain.
Unlike opioid drugs, which attenuates the feeling of pain in the brain, suzetrigin works by preventing the painting nerves around the body from shooting in the first place.
“This medication, what it does is interrupting this path, so even if the tissue injury exists, the brain does not know,” said Bergese.
And above all, suzetrigine does not create euphoria or high opioids as sometimes, so doctors believe that there is no potential to create dependence or dependence in people who use it.
The drug was discovered after the researchers learned a family of fire walkers in Pakistan and discovered that they lacked a gene allowing pain signals to shoot in their skin. Members of this family could walk on hot coals without starting.
“They knew they were on something hot; They knew they could feel the coals. So that has no impact on the nerves that make heat and touch and stuff like that. These are only these ribs conductive of pain, ”said Stuart Arbuckle, chief of the Green Pharmaceuticals. “They were, in all other, normal ways.”
However, scientists took 25 years to understand how to exploit this hand -driving mechanism to develop a medication.
“The neurons speak to themselves by producing series of nerve pulses, such as a Morse code,” said Dr. Stephen Waxman, who directs the Center for Neuroscience and Regeneration Research at the Yale School of Medicine. “And nerve impulses are produced by tiny molecular batteries in neurons membranes. Molecular batteries are called sodium channels. »»
Suzetrigin works by closing a sodium channel that only drives pain signals.
There have been many false starts along the way to find a medication that could block a specific sodium channel. Suzetrigine approval means that other drugs that could work even better are likely to follow, Waxman said.
“It is an important step forward, because it provides proof of concept that a (sodium channel blocker) can reduce pain in humans,” said Waxman, who has no financial link with the new medication. “This opens the door to a second generation of even more effective (drugs).”
Suzetrigine is a pill which is given in two dosages. In studies, participants obtained an initial dose of 100 milligrams, followed by 50 milligrams every 12 hours.
Doctors point out that it may not be the right medication for everyone or for each type of pain.
In two clinical trials which included nearly 600 participants, suzetrigine controlled pain after abdominal surgery and feet better than an inactive placebo pill. About as many people have said that suzetrigin has reduced their pain by at least half after surgery as those who took Vicodin, which is a combination of acetaminophen and opioid hydrocodone. Research has not been designed to directly compare Suzetrigine to Vicodin, however, it is therefore difficult to know if one worked better than the other.
On a well -known rating scale which takes place from 0 to 10, the study participants began with a pain of about seven, on average, and suzetrigine reduced it approximately 3.5 points.
“It’s not like eliminating all pain,” said Arbuckle. “This reduces pain by around 50%.”
In a third study, among people suffering from back pain caused by sciatica, suzetrigine reduced pain by about 2 points, the same amount reported by people taking a placebo, which suggests that this medication might not Be a little remarkable for chronic pain.
Vetex does not agree, saying that he has tested the drug in different types of chronic pain and that he also seems to work for long -term pain. The company continues to test it in people with diabetic neuropathy, in which high blood sugar levels damage the nerves over time, causing symptoms such as numbness, tingling, pain and muscle weakness.
The sciatica study was smaller than the others, with around 100 people in the Suzetrigine arm and in the placebo group, so there may not be enough participants to show clear differences between the groups. Placebos also tend to have important effects in pain studies, which complicates their interpretation.
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“In our opinion, the drug did what we expected to do in terms of pain relief,” said Arbuckle. “But unfortunately, as often happens in pain studies, there is a fairly important placebo response.”
Doctors who help people manage pain said they were delighted to have a new option.
“The more options we have, the better we are able to treat each patient,” said Dr. Kimberley Mauer, Oregon Health and Science University anesthesiologist.
Mauer said the cost could be an important factor in the way the drug is used. Vertex said he had fixed a wholesale cost of $ 15.50 per pill of 50 mg, but that patient assistance programs would be available.
Mauer said doctors and patients should wait to find out what insurance companies could do in terms of coverage.
“This could limit some patients to obtain it. So we have to see in a way, and it is difficult to say until it comes out on the market, “she said.