Find Clinical Drug Pipeline Developments & Deals for Cyclobenzaprine Hydrochloride

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Both of the current Phase 3 trials are studying TNX-102 SL at a dose of 5.6 mg which is twice the 2.8 mg dose used in the Company’s prior Phase 2 and 3 studies in fibromyalgia.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 10, 2020

            Details:

            Tonix Pharmaceuticals has met its target enrollment of approximately 470 participants in its Phase 3 RELIEF trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, ahead of schedule.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 21, 2020

            Details:

            A poster to be presented includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD).

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 24, 2020

            Details:

            50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial evaluating TNX-102 SL for the management of fibromyalgia.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 05, 2020

            Details:

            RECOVERY study has stopped enrollment due to inadequate separation from placebo at week-12 based on interim analysis results of the first 50% of enrolled participants.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 24, 2020

            Details:

            Tonix expects the data to satisfy pharmacokinetic requirements for potential New Drug Applications (NDA) for TNX-102 SL for PTSD and Fibromyalgia.