The Food and Drug Administration (FDA) has granted Fast Track designation to basimglurant (NOE-101) for the management of pain associated with trigeminal neuralgia.
Basimglurant is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5), which has been shown to be overexpressed in chronic pain. The Company is currently evaluating the efficacy and safety of basimglurant in adults with pain associated with trigeminal neuralgia in a prospective, double-blind, randomized-withdrawal, placebo-controlled phase 2/3 trial (LIBRATN; ClinicalTrials.gov Identifier: NCT05217628). The primary endpoint of the study is time to loss of efficacy or pain recurrence defined as the confirmed increase in the number of weekly paroxysms or reemergence of continuous pain and/or the need for rescue medication. Topline data is expected in the first quarter 2024.
“We are very pleased to receive Fast Track designation from the FDA, which is intended to bring promising medicines to patients sooner, and very much underlines the potential of basimglurant in pain management associated with [trigeminal neuralgia],” said George Garibaldi MD, President, Head of R&D of Noema Pharma. “The designation means we will be working closely with the FDA’s Division of Anesthesia, Addiction Medicine, and Pain Medicine, which regulates Investigational New Drug applications and marketing applications of drugs for the treatment of pain.”
This article originally appeared on MPR
Noema Pharma receives FDA Fast Track designation for basimglurant (NOE-101) in trigeminal neuralgia. News release. Noema Pharma. Accessed October 18, 2022. https://www.globenewswire.com/news-release/2022/10/18/2536323/0/en/Noema-Pharma-Receives-FDA-Fast-Track-Designation-for-basimglurant-NOE-101-in-Trigeminal-Neuralgia.html