- Tonix Pharmaceuticals (TNXP +3.4%) moves closer to an NDA filing for posttraumatic stress disorder (PTSD) med Tonmya (cyclobenzaprine HCl sublingual tablets) with the conclusion of a multi-dose pharmacokinetic bridging study with the reference listed drug (RTD) AMRIX (cyclobenzaprine HCl extended-release capsules).
- Preliminary data showed plasma levels and exposure of 5.6 mg of Tonmya were less than 30 mg of AMRIX after 20 days of dosing. Additionally, the systemic exposure of cyclobenzaprine and its principal active metabolite norcyclobenzaprine from Tonmya was less than AMRIX at steady-state. Adverse event data were as expected.
- The aim of the bridging study is the affirm the validity of using safety data on AMRIX to support the Tonmya marketing application under the FDA's abbreviated 505(b)(2) pathway which allows the inclusion of data generated by others.
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