Tonix receives IND approval for sublingual formulation to treat PTSD

Tonix Pharmaceuticals ($TNXP) announced June 10 that its investigational reformulation of cyclobenzaprine, TNX-102 SL, received IND clearance from the FDA for the treatment of post-traumatic stress disorder. The news comes about a month after the company said that TNX-102 SL's pivotal trial for the treatment of fibromyalgia completed enrollment.

The development means the sublingually delivered therapy for PTSD should begin double-blind, placebo-controlled Phase II trials in Q3 2014, Tonix said in a statement. It aims to be the first to sell sublingually delivered cyclobenzaprine, which is not currently indicated to treat PTSD in any form.

Sublingual delivery is superior to oral ingestion because the method moves cyclobenzaprine into the bloodstream faster and increases the absorption rate by a factor of 10, Tonix CEO Dr. Seth Lederman said in a previous interview with FierceDrugDelivery about the candidate's fibromyalgia trial.

"The clearance of this IND represents an important milestone for Tonix and for the estimated 8 million U.S. adults with PTSD, a serious illness with unmet needs and limited treatment options," Lederman said in a statement.

During the trial, TNX-102 SL will be administered daily at bedtime, similar to the candidate's use in another trial for fibromyalgia. Tonix says that the candidate is designed to treat both by improving sleep quality.

"As with our IND of TNX-102 SL for fibromyalgia, our goal is to develop a new approach to a common central nervous system disorder with the potential to alter treatment paradigms. We are very excited about investigating the safety and efficacy of TNX-102 SL in PTSD while our potential pivotal study in fibromyalgia, the BESTFIT trial, has completed enrollment with top-line results available later this year," Lederman said in the statement.

Cyclobenzaprine is a muscle relaxant that is currently available in oral suspension, tablet and extended-release capsule form, according to the Mayo Clinic. The Department of Veterans Affairs says that sertraline (marketed as Zoloft) and paroxetine (Paxil) are the only approved medications for PTSD. 

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