Tonix Pharmaceuticals’ sublingual pill, Tonmya, has been approved by the FDA for treating fibromyalgia, a condition characterized by chronic widespread pain and poor sleep. The oral pill showed significantly superior analgesic effects in patients with fibromyalgia compared to placebo in Phase III studies.
Patients will now have access to an effective treatment option after over a decade of waiting. Tonmya is a non-opioid analgesic designed to be quickly absorbed into the bloodstream when taken under the tongue before sleep. The FDA approval addresses approximately 10 million patients suffering from fibromyalgia in the US market.
The company expects to launch Tonmya in the fourth quarter this year. Common side effects include mouth numbness, oral discomfort, drowsiness, fatigue, and mouth pain. Tonix CEO Seth Lederman hailed the approval as a “landmark advancement” for patients with fibromyalgia.
This regulatory win comes as Vertex Pharmaceuticals faces challenges with its next-generation pain medicine VX-993, which was unable to significantly ease pain after a surgical procedure. In contrast, Tonmya’s approval marks a significant breakthrough in treating fibromyalgia, offering new hope to those affected by the debilitating condition.
Source: https://www.biospace.com/fda/tonix-wins-approval-for-first-new-fibromyalgia-drug-in-over-15-years