By Siddhi Mahatole and Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration has approved Tonix Pharmaceuticals’ drug to manage pain related to a type of chronic condition called fibromyalgia, the company said on Friday.
The approval paves the way for the drug to be the first new treatment option in over 15 years for patients with fibromyalgia, which causes widespread pain, fatigue as well as problems with sleep and memory.
Patients have so far relied on older drugs such as Lyrica, Cymbalta and AbbVie’s Savella.
The non-opioid drug, which will be sold under the brand name Tonmya, is a pill designed for bedtime treatment to improve sleep quality and reduce pain associated with the chronic condition.
“This is the first time that a drug has been developed to target the non-restorative sleep, which we think plays an important role in fibromyalgia,” CEO Seth Lederman said in an interview with Reuters ahead of the decision.
Tonix’s application to the health regulator was based on two late-stage studies, in which the drug significantly reduced daily pain compared to placebo at 14 weeks.
Fibromyalgia has long been misunderstood and dismissed by doctors but is now widely recognized, with millions of patients being diagnosed with the condition.
The drug in the studies showed side-effects of numbness of the tongue or mouth, which was related to dosing that led to the discontinuation of one patient in each study.
“At present, there is a gap or room for more treatment options in terms of fibromyalgia treatment,” said Syed Alam, a rheumatology specialist at Houston Methodist.
He added that the currently available medication options have limited effectiveness.
This represents a big opportunity for Tonix, said David Bautz, a Zacks Small-Cap Research analyst, who estimates peak U.S. sales at $800 million for the drug after seven to eight years post launch.
Tonix said the drug will be available by the fourth quarter.
(Reporting by Siddhi Mahatole, Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Vijay Kishore and Shreya Biswas)
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