Tonix Pharmaceuticals (TNXP) on Watch Following Presentation of TNX-102 SL Data in PTSD
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Tonix Pharmaceuticals (Nasdaq: TNXP) shares are on watch Monday after the company presented efficacy results of a retrospective analysis of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related PTSD in a poster at CNS Summit 2016 being held October 27-30, 2016 in Boca Raton, Florida.
The following summary was offered by the company:
- The At Ease study is one of the first pharmacotherapy trials to employ the latest version of the CAPS, which is based on the definition of PTSD in the DSM-5. The analyses described herein demonstrated that a CAPS-5 severity score of .33 for study inclusion is more comparable to the severity threshold used in past registration trials of the approved PTSD pharmacotherapies.
- Retrospective analysis of the At Ease sample using this .33 threshold for entry demonstrated substantially larger effect sizes, compared with .29, of the TNX-102 SL 5.6mg on total CAPS-5 (0.53v.0.36)and the Arousal & Reactivity (0.52v.0.35), Intrusion (0.46v.0.26), and Mood/Cognitions (0.39v.0.35) clusters
- The CAPS-5 severity score of .33 was determined to be appropriate for inclusion in planned Phase 3 testing of TNX-102 SL 5.6mg in PTSD
- Overall TNX-102SL was well tolerated. Oral hypoesthesia (ortonguenumbness) was most common, generally transient, and never rated as severe.
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