An estimated 5.2 million people have post traumatic stress disorder. About 103,000 veterans of Afghanistan and Iraq have been diagnosed with the disorder, according to the Centers for Disease Control, with lots more cases expected. But there are few options available to treat the condition, aside from anti-depressants and off-label approaches. In an interview, specialty pharma company Tonix Pharmaceuticals CEO Seth Lederman told MedCity News how his company planned to change that.
Earlier this month, the U.S. Food and Drug Administration cleared Tonix Pharmaceutical’s (Nasdaq: TNXP) investigational new drug application to use its sublingual formulation of cyclobenzaprine to treat PTSD. Under the IND, Tonix plans to advance a U.S.-based Phase 2 clinical trial to evaluate the safety and efficacy of the drug, TNX-102 SL, in patients with PTSD. Cyclobenzaprine is a muscle relaxant that blocks nerve impulses to the brain.
The 12-week study will seek to enroll 220 patients with military-related PTSD at about 30 sites in the U.S. The primary efficacy analysis will compare differences in mean scores on the Clinician-Administered PTSD Scale.
There are a few reasons why there are few PTSD drugs available. Investment in CNS drug development has fallen. Animals aren’t an effective model, which means drugs in development carry more late-stage risk. There’s also no structure for recruiting PTSD patients and it’s a challenging patient population to recruit and work with, according to Lederman. Although he emphasized it has not yet collaborated with the government, Lederman said the company would be open to working with the government at some point.
The only two FDA-approved medications for the treatment of PTSD are sertraline (Zoloft) and paroxetine (Paxil).
Tonix also is developing an indication to treat fibromyalgia that’s taken at bedtime. Common complaints from the condition are hurting all over and non-restorative sleep. Sure, they may actually sleep, but they reap no benefits from it. Lederman views fibromyalgia as a condition that has not been adequately addressed by pharma companies. The drug could make a big difference. Tonix completed enrollment for the first of two Phase 2 clinical trials for fibromyalgia last month. It expects to file an NDA for its fibromyalgia indication in 2016.
About 5 million adults have fibromyalgia, according to data from the Centers for Disease Control.
