Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) held a type B pre-investigational new drug (IND) meeting with FDA to devise a plan for the development of tianeptine oxalate and naloxone controlled-release (TNX-601 CR) to cure MDD.
TNX-601 CR treats posttraumatic stress disorder
Following a pre-IND meeting with FDA, Tonix received an official communication to treat the major depressive disorder (MDD) by developing a novel oral formulation – TNX-601 CR. The new formulation will also be used to cure neurocognitive dysfunction related to corticosteroids and posttraumatic stress disorder.
Amorphous is already available in Latin America, several Asian nations, and Europe to treat depression for over 30 years.
Expects to file for IND
Tonix will file for IND for carrying out potential human abuse trial soon following the receipt of official minutes. It will soon meet the US FDA’s controlled substances staff to agree on abuse potential trial details.
On getting the ongoing NTT (nonclinical toxicology trial) and human APS (abuse potential study) results, Tonix will conduct a Phase 2 clinical trial of the drug to treat MDD in Q4 2021.
CEO of Tonix, Seth Lederman, said the company is thrilled with the US FDA’s official minutes to develop TNX-601 CR to cure MDD. It plans to advance clinical development. He further said several nations worldwide have already approved Tianeptine products and in use for more than 30 years in treating depression.
Seth said TNX-601 CR will satisfy the bioequivalence protocol for daily administration. The US FDA already approved the product free from tianeptine.
No impact on sexual desire
The proposed action of TNX-601 CR is different from already approved antidepressants in the US. Tonix has developed TNX-601 CR for daily administration. Tianeptine sodium IR efficiency is on par with tricyclic antidepressants and SSRI (selective serotonin inhibitor). Unlike other antidepressants available in the market, TNX-601 CR will not have any impact on sexual desire.
Around 17 million adult Americans have suffered from major depression at least once in their life. Adjunctive therapy is used to treat 2.5 million people in the US. The symptoms of depression are loss of interest or depressed mood.