Trial Outcomes & Findings for A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients (NCT NCT02589275)

NCT ID: NCT02589275

Last Updated: 2025-02-20

Results Overview

The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 375 participants
• Primary outcome timeframe: Up to 3 months from first dose
• Results posted on: 2025-02-20

Participant Flow

Participant milestones

Measure	TNX-TNX This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	PBO-TNX This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.
Overall Study STARTED	177	198
Overall Study COMPLETED	143	142
Overall Study NOT COMPLETED	34	56

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

Baseline characteristics by cohort

Measure	TNX-TNX n=177 Participants This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	PBO-TNX n=198 Participants This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	Total n=375 Participants Total of all reporting groups
Age, Continuous	48.2 years STANDARD_DEVIATION 11.35 • n=5 Participants	48.0 years STANDARD_DEVIATION 10.77 • n=7 Participants	48.1 years STANDARD_DEVIATION 11.03 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	191 Participants n=7 Participants	360 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	166 Participants n=5 Participants	172 Participants n=7 Participants	338 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	177 participants n=5 Participants	198 participants n=7 Participants	375 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months from first dose

Population: Data is reported for all patients with AE data collected at the time when this study was terminated.

The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.

Outcome measures

Measure	TNX-TNX n=170 Participants This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	PBO-TNX n=186 Participants This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.
Newly Emergent Adverse Events	77 Participants	132 Participants

Adverse Events

TNX-TNX

Serious events: 2 serious events

Other events: 69 other events

Deaths: 0 deaths

PBO-TNX

Serious events: 0 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Measure	TNX-TNX n=170 participants at risk This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	PBO-TNX n=186 participants at risk This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.
Blood and lymphatic system disorders Lymphadenopathy	0.59% 1/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	0.00% 0/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.
Infections and infestations Chronic sinusitis	0.59% 1/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	0.00% 0/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.
Reproductive system and breast disorders Ovarian cyst	0.59% 1/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	0.00% 0/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.

Other adverse events

Measure	TNX-TNX n=170 participants at risk This group received 1x 2.8 mg TNX-102 SL sublingual tablet daily in the lead in study TNX-CY-F301, then continued to receive 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.	PBO-TNX n=186 participants at risk This group received 1x Placebo sublingual tablet daily in the lead in study TNX-CY-F301, then received 1x 2.8 mg TNX-102 SL sublingual tablet in this open-label extension study.
Gastrointestinal disorders Hypoaesthesia Oral	35.3% 60/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	39.2% 73/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.
Gastrointestinal disorders Parasthesia Oral	5.3% 9/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	5.9% 11/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.
Gastrointestinal disorders Tongue Discomfort	2.9% 5/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	8.1% 15/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.
Product Issues Product Taste Abnormal	5.3% 9/170 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.	10.8% 20/186 • Up to 3 months from first dose. All-cause mortality is reported for all patients. For AEs and SAEs, data is reported for all patients with AE data collected at the time when this study was terminated.

Additional Information

Gregory Sullivan, MD

Tonix Pharmaceuticals

Phone: (862) 904-0355

Email: greg.sullivan@tonixpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee An industry standard NDA is in place with all study investigators.
• Publication restrictions are in place

Restriction type: OTHER