Tonix Pharmaceuticals Gets FDA Review of Fibromyalgia Drug

Dow Jones12-17

By Colin Kellaher

Tonix Pharmaceuticals Holding said the Food and Drug Administration has accepted its application seeking approval of its TNX-102 SL product candidate for the chronic pain condition fibromyalgia.

Tonix on Tuesday said it expects the FDA to communicate a target action date and a decision on whether to grant priority review to the application in a so-called "Day 74" letter, which the agency issues within 74 days from its receipt of a submission.

The Chatham, N.J., company said TNX-102 SL, a non-opioid, sublingual pain reliever, has the potential to be the first member of a new class of analgesic drugs for fibromyalgia, adding that an FDA green light would make it the first new drug for treating fibromyalgia in more than 15 years.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

December 17, 2024 08:30 ET (13:30 GMT)

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