For people who suffer from a persistent itch of any type, relief might seem elusive at times.
For centuries, people have struggled with an itch around the shoulder blades, which is difficult to relieve. For some individuals, the itch becomes so persistent and unbearable that finding a way to scratch it becomes an obsession.
Notalgia paresthetica (NP) is a widespread skin condition marked by itching on one side of the body, either near or below the shoulder blade.
Astwazaturow originally documented the illness in 1934, yet the complaint of a persistently itching back has most likely troubled individuals from the beginning of time.
NP is a common and underdiagnosed nerve disorder that causes a chronic itch in the upper back. There are currently no FDA-approved therapies for this particular condition.
However, recent research that was published in the New England Journal of Medicine reveals that people who have the disorder’s moderate to severe itching may find some relief by taking oral difelikefalin. The study was conducted by researchers at Mount Sinai’s Icahn School of Medicine.
Currently, the FDA has only licensed the selective kappa-opioid receptor agonist difelikefalin as an injectable for the treatment of moderate-to-severe chronic kidney disease-related itching in individuals on hemodialysis.
“For those who experience chronic itch of any kind, relief can sometimes seem unattainable,” remarks senior author Brian S. Kim. “In this Phase 2 trial, treatment with difelikefalin resulted in a reduction in the intensity of itch in patients with notalgia paresthetica.”
In the double-blind, placebo-controlled experiment, patients with moderate-to-severe itching due to NP were randomly allocated to receive 2 mg of oral difelikefalin or a placebo twice daily for eight weeks. The most important result was the change in the weekly mean of the daily Worst Itch Numeric Rating Scale over eight weeks. On this scale, 0 means “no itch” and 10 means “worst itch already imaginable.” Measures of itch-related quality of life and sleep were secondary clinical outcomes.
62 of the 126 patients who were recruited were given difelikefalin, while 63 received a placebo. In each group, the baseline means Worst Itch Numeric Rating Scale score was 7.6 (severe itch). Patients receiving difelikefalin saw a 4.0 point drop from baseline in the worst itch score at week eight compared to patients receiving placebo, who experienced a 2.4 point drop. In general, secondary results did not support the main study. Difelikefalin caused headaches, lightheadedness, constipation, and a rise in urine production.
To more accurately evaluate the effectiveness and safety of difelikefalin in notalgia paresthetica, larger studies are required. This treatment would be the first one to be FDA-approved exclusively for NP sufferers if Phase 3 clinical study results go as planned.
“The encouraging results achieved in this trial could reenergize the field and mark an important step toward improving symptoms of itch for patients with notalgia paresthetica,” remarks senior author Dr. Kim.
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