> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Ex-CDER Official Laughren Retained by PharmaTher
- URL: https://www.fdaweb.com/ex-cder-official-laughren-retained-by-pharmather/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:16:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150267

PharmaTher Holdings has retained former CDER Division of Psychiatry Products director **Thomas Laughren, who retired in 2012,** as a regulatory affairs advisor. The company says Laughren will advise on regulatory matters involving KetaBet, its patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for neuropsychiatric disorders.

Laughren will work with **Maurizio Fava**, the company’s scientific and clinical advisor and psychiatrist-in-chief at Massachusetts General Hospital, to complete an IND application for submission to FDA for evaluating KetaBet in a Phase 2 clinical study as a potential treatment for depression, PharmaTher says.

KetaBet has been shown in a research study to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine, the company says. “Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine,” it says.