Tonix advances TNX-102 SL for depression after positive FDA meeting boosts development path

Tonix advances TNX-102 SL for depression after positive FDA meeting boosts development path

Tonix Pharmaceuticals Holdings CEO Dr. Seth Lederman shared with Steve Darling from Proactive to share a major milestone in the company’s clinical development pipeline — the successful completion of a Type B Pre-Investigational New Drug meeting with the U.S. Food and Drug Administration regarding the potential development of TNX-102 SL for the treatment of major depressive disorder.

Lederman said the FDA provided positive and constructive feedback, giving Tonix the confidence to move forward with plans to submit a supplemental new drug application to expand the therapeutic indications of TNX-102 SL. The company’s approach is based on exploratory findings that suggest improving sleep quality may help alleviate depressive symptoms, offering a novel route to address a condition that affects millions and remains underserved by current therapies.

Tonix believes that bedtime administration of TNX-102 SL could represent a first-in-class treatment by targeting the reduced quality and quantity of slow-wave sleep associated with depression. The medication is a tertiary amine tricyclic formulated for transmucosal absorption, allowing it to bypass first-pass hepatic metabolism.

By contrast, currently approved tertiary amine tricyclic antidepressants are swallowed-pill formulations that are largely metabolized during first-pass to longer-lived secondary amine tricyclics. These older drugs typically require doses more than ten times higher than TNX-102 SL to be effective for MDD and are often associated with side effects such as weight gain, blood pressure changes, cognitive impairment, and sexual dysfunction.

Tonix’s development strategy aims to offer a more tolerable and targeted therapy for MDD by addressing sleep disruption — a known contributor to depressive symptoms — while minimizing the side effects seen with traditional treatments.

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