A sublingual formulation of cyclobenzaprine HCl, a muscle relaxant that blocks nerve impulses to the brain, is currently being researched as an investigational treatment for post-traumatic stress disorder (PTSD).
Tonix Pharmaceuticals will proceed with a phase 2 clinical trial to assess the safety and effectiveness of TNX-102 SL. The 12-week study seeks to enroll 220 patients with military-related PTSD at about 30 U.S. sites and will assess the drug's affect on mean scores on the Clinician-Administered PTSD Scale. Researchers will evaluate the safety and efficacy of two doses of TNX-102 SL and placebo administered once daily at bedtime.
Currently, there are only two FDA-approved medications to treat PTSD -- the selective seratonin reuptake inhibitors sertraline (Zoloft) and paroxetine (Paxil). Cyclobenzaprine HCI is indicated for relief of acute muscle spasm, as adjunct to rest and physical therapy.
About 3.5% of U.S. adults have PTSD, but many do not receive treatment for their condition, and 42% of those who do are receiving “minimally adequate” therapy, according to the National Institutes of Mental Health.
The FDA has cleared Tonix Pharmaceuticals’ Investigational New Drug (IND) application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, to treat post-traumatic stress disorder (PTSD).
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From Pharmaceutical Business Review
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