Gabapentinoid

Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia

Retrieved on: 
Tuesday, January 9, 2024

CHATHAM, N.J., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at Biotech Showcase™ 2024 in San Francisco, January 8-10.

Key Points: 
  • As previously announced, RESILIENT met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for TNX-102 SL for the management of fibromyalgia.
  • RELIEF, the first Phase 3 trial of TNX-102 SL 5.6 mg in fibromyalgia, was completed in December 2020.

Scilex Holding Company Presented Oral and Poster Presentations on ZTlido (lidocaine topical system) at the 2023 Annual PAINWeek Conference Held in Las Vegas, NV

Retrieved on: 
Tuesday, September 12, 2023

PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual PAINWeek Conference on the benefits of ZTlido (lidocaine topical system).

Key Points: 
  • PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual PAINWeek Conference on the benefits of ZTlido (lidocaine topical system).
  • The conference was held from September 5-8, 2023 in Las Vegas, NV.
  • Impact of Adhesion on Patient Satisfaction, Medication Switching and Discontinuation with Lidocaine Topical Patches Based on FDA Adverse Event Reporting and Patient Surveys.
  • “More new data presented to support superior adhesion qualities of ZTLido, as well as decreased healthcare resource utilization compared to Lidocaine 5% patch demonstrating significant reduction in outpatient visits and ER/Urgent Care visits.

Global Diabetic Neuropathic Pain Market Report to 2031: Players Include AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly and GlaxoSmithKline - ResearchAndMarkets.com

Retrieved on: 
Monday, May 15, 2023

Annualized diabetic neuropathic pain therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2021 to 2031.

Key Points: 
  • Annualized diabetic neuropathic pain therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2021 to 2031.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the diabetic neuropathic pain therapeutics market.
  • Analysis of the current and future market competition in the global diabetic neuropathic pain therapeutics market.
  • Develop business strategies by understanding the trends shaping and driving the global diabetic neuropathic pain therapeutics market.

Christopher J. Dy, MD, FAAOS, Named 2023 Kappa Delta Young Investigator Award Winner

Retrieved on: 
Friday, February 10, 2023

ROSEMONT, Ill., Feb. 10, 2023 /PRNewswire/ -- The 2023 Kappa Delta Young Investigator Award was presented to Christopher J. Dy, MD, MPH, FACS, FAOA, FAAOS, for his research on how brachial plexus injuries (BPI) affect patients' quality of life. Dr. Dy's research found that existing studies and outcomes did not account for the emotional, psychological and pain-related aspects as patients recovered from BPI surgery and identified a disconnect between surgical outcomes and patient satisfaction. To read more about the award recognizing investigators under 40 years old, please click here.

Key Points: 
  • ROSEMONT, Ill., Feb. 10, 2023 /PRNewswire/ -- The 2023 Kappa Delta Young Investigator Award was presented to Christopher J. Dy, MD, MPH, FACS, FAOA, FAAOS, for his research on how brachial plexus injuries (BPI) affect patients' quality of life.
  • To read more about the award recognizing investigators under 40 years old, please click here .
  • "We use a lot of tools to assess the injury – patient examination, MRIs, nerve studies – but none of it is perfect.
  • Even following surgical treatment, full function cannot be restored, leaving many BPI patients frustrated and with unmet functional needs.

Neuros Medical Announces Completion of QUEST Pivotal Trial 90-day Primary Endpoints

Retrieved on: 
Monday, June 6, 2022

ALISO VIEJO, Calif., June 6, 2022 /PRNewswire/ -- Neuros Medical, Inc., a medical device company developing an innovative, on-demand bioelectric nerve block therapy for patients with intractable post-amputation pain, announced today the completion of its QUEST Pivotal Trial 90-day primary endpoints.

Key Points: 
  • ALISO VIEJO, Calif., June 6, 2022 /PRNewswire/ -- Neuros Medical, Inc., a medical device company developing an innovative, on-demand bioelectric nerve block therapy for patients with intractable post-amputation pain, announced today the completion of its QUEST Pivotal Trial 90-day primary endpoints.
  • QUEST is a 180-subject randomized, double blinded, active sham controlled clinical trial that is being conducted under an Investigational Device Exemption (IDE).
  • QUEST is designed to assess the safety & effectiveness of the Company's AltiusBioelectric Nerve Block Technology to treat intractable post-amputation pain.
  • Post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.

Neuros Medical Announces Completion of Enrollment in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain

Retrieved on: 
Wednesday, September 15, 2021

QUEST is designed to assess the safety & effectiveness of the Company's AltiusHigh-Frequency Nerve Block system to treat intractable post-amputation pain.

Key Points: 
  • QUEST is designed to assess the safety & effectiveness of the Company's AltiusHigh-Frequency Nerve Block system to treat intractable post-amputation pain.
  • Post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.
  • Neuros Medical, a neuromodulation company, has developed the Altius system for the treatment of chronic post-amputation pain (phantom limb pain and residual limb pain).
  • Post-amputation pain includes both phantom limb and residual limb (or "stump") pain, and impacts nearly one million Americans.

Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius® High Frequency Nerve Block System

Retrieved on: 
Tuesday, June 29, 2021

Chronic post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.

Key Points: 
  • Chronic post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.
  • Neuros anticipates completion of enrollment in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study by the Fall of 2021.
  • QUEST is designed to assess the safety & effectiveness of the Company's AltiusHigh-Frequency Nerve Block system to treat intractable chronic post-amputation pain.
  • Neuros Medical, a neuromodulation company, has developed the Altius system for the treatment of chronic post-amputation pain (Phantom Limb Pain and Residual Limb Pain).