Eli Lilly has revealed that it recently submitted a supplemental New Drug application to US regulators for the antidepressant Cymbalta for the management of fibromyalgia and has unveiled new study data to support its bid.
The new data, which was presented at the Congress of the International MYOPAIN Society in Washington DC, suggests that patients with fibromyalgia, one of the most common chronic conditions which affects more than six million Americans, and is thought to result from neurological changes in how patients perceive pain, who received Cymbalta (duloxetine) experienced a greater reduction in pain, compared with those on placebo.
In the six-month study, involving 520 patients with fibromyalgia with or without depression, those administered Cymbalta experienced a greater reduction in pain severity starting one week after initiating treatment, compared with those who received placebo. At three months, patients who received duloxetine had a significantly greater reduction in pain, compared to patients in the control group.
The study was one of five submitted by Lilly as part of the expanded fibromyalgia application, which has provided data on 1,400 patients. The firm’s chief medical officer Alan Breier noted that “lack of awareness of fibromyalgia can lead to frustration as patients often see multiple physicians over a number of years before receiving a formal diagnosis" and “this research may help increase recognition” of the condition, which is usually accompanied by poor sleep, stiffness, depression and fatigue.
An approval for the new indication would be of great benefit to Cymbalta sales which jumped 67% in the second quarter to $519.5 million. It is currently approved in the USA for adults with major depressive disorder, generalised anxiety disorder and the management of diabetic peripheral neuropathic pain. If given the green light for fibromyalgia, it will go up against Pfizer’s Lyrica (pregabalin), which was approved by the US Food and Drug Administration in June, while future competition could come from Wyeth’s Pristiq (desvenlafaxine) and UCB’s Xyrem (sodium oxybate).