Tonix Drops Fibromyalgia, Will Pursue PTSD Claim With Cyclobenzaprine Formulation

Failing to meet the primary endpoint of a Phase III trial of TNX-102 SL in fibromyalgia, cash-limited Tonix decides to focus on developing the drug for PTSD – which it thinks is the path of least regulatory resistance. A pair of pivotal trials is slated to commence in 2017.

With limited cash flow, Tonix Pharmaceuticals Holding Corp. is shelving development of its sublingual formulation of the muscle relaxer cyclobenzaprine in fibromyalgia to focus on post-traumatic stress disorder, because of greater clarity in terms of the regulatory path forward.

On Sept. 6, the New York-based firm reported that TNX-102 SL, a sublingual formulation of cyclobenzaprine designed to evade first-pass...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By 

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

More from R&D

UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By 

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By 

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges