THE NEW YORK TIMES – The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.
That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.
Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.
To test the drug, Vertex, which is based in Boston, conducted two large clinical trials, each with approximately 1,000 patients who had pain from surgery.
They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.
“There are a number of people who, once they have an opioid, want an opioid constantly.” – Dr. John D. Loeser
In one trial, patients had an abdominoplasty, or tummy tuck. In the other, they had a bunionectomy. Side effects of suzetrigine reported by patients were similar to the ones reported by those taking the placebo.
The company also submitted data from a 250-person study that assessed the drug’s safety and tolerability in patients with pain from surgery, trauma or accidents.
Suzetrigine eased pain as much as the combination opioid. Both were better than the placebo at relieving pain.
Suzetrigine’s price, though, is much higher than that of acetaminophen plus hydrocodone.
Patients are expected to take two pills a day, for a total cost of $31 a day. The older drug, said Dr. John D. Loeser, an emeritus pain expert at the University of Washington, is “dirt cheap” at pennies per pill.
But suzetrigine does not have opioids’ unpleasant side effects like nausea and drowsiness, and it is nonaddictive …
