Corporate Banner
Satellite Banner
ADME Tox
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Tonix Pharmaceuticals Announces Completion of Clinical Trial for TNX-102

Published: Tuesday, July 31, 2012
Last Updated: Tuesday, July 31, 2012
Bookmark and Share
Results support development as a bedtime therapy for fibromyalgia.

Tonix Pharmaceuticals Holding Corp. announces that the clinical portion of a human study of a solution version of TNX-102 2.4 mg sublingual tablets ("TNX-102 SL") has completed. TNX-102 is TONIX's very low dose form of cyclobenzaprine, which the Company is developing as a first-in-class medication for the management of FM.

This comparative pharmacokinetic ("PK") and bioavailability study was conducted in Canada by a leading global clinical research organization. The trial evaluated a solution formulation of the Company's TNX-102 SL tablet containing 2.4 mg of cyclobenzaprine, a control sublingual solution that was designed to simulate crushed immediate-release cyclobenzaprine tablets (2.4 mg), oral ingestion of an immediate-release cyclobenzaprine tablet (5 mg), and intravenous cyclobenzaprine (2.4 mg). The study enrolled 23 healthy adult volunteers and periodically measured circulating blood levels of cyclobenzaprine over six days after receiving study medication.

Seth Lederman, M.D., Chairman and President of TONIX said, "We designed TNX-102 SL to work overnight following bedtime administration, with the goal of improving the pain and other symptoms of FM by improving sleep quality. We view these results as highly encouraging. This was a stringent test of sublingual absorption of cyclobenzaprine, as patients receiving sublingual formulations were instructed to spit and rinse 90 seconds following administration. TNX-102 SL was well-tolerated, and no serious adverse events were reported. The PK results demonstrated that the solution formulation of TNX-102 SL delivered cyclobenzaprine to the systemic circulation more efficiently than the sublingual solution of a simulated crushed tablet and faster than the ingested tablet. We believe the kinetics of plasma cyclobenzaprine demonstrated by TNX-102 SL will translate to more rapid effects compared with current cyclobenzaprine products. We believe these improvements favor its advancement in the FM indication. The data also indicate that, in contrast to our proprietary formulation, sublingual absorption cannot be achieved by crushing currently-available cyclobenzaprine products. We are on track to commence a pivotal clinical trial of TNX-102 SL tablets for FM in the first quarter of 2013."

FM is a common and complex central nervous system condition characterized by chronic diffuse musculoskeletal pain, increased pain sensitivity at multiple tender points, fatigue, abnormal pain processing, and disturbed sleep, and often features psychological stress. In a Phase 2a trial, TONIX demonstrated that bedtime administration of very low dose cyclobenzaprine improves core FM symptoms including pain, tenderness, fatigue, and depression, and also demonstrated that improvements in key symptoms correlate with increased nights of restorative sleep. These results were published in the December 2011 issue of the Journal of Rheumatology. Previous studies of the mechanism by which cyclobenzaprine works have discovered that it acts selectively on serotonin receptor type 2a (5HT2a) and alpha-2 adrenergic receptors. Serotonin is thought to play a major role in the central inhibition of pain.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
RNAi Screening Trends
Understand current trends and learn which application areas are expected to gain in popularity over the next few years.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
Long-sought Discovery Fills in Missing Details of Cell 'Switchboard'
A biomedical breakthrough reveals never-before-seen details of the human body’s cellular switchboard that regulates sensory and hormonal responses.
Tracking Breast Cancer Before it Grows
A team of scientists led by University of Saskatchewan researcher Saroj Kumar is using cutting-edge Canadian Light Source techniques to screen and treat breast cancer at its earliest changes.
Zebrafish Reveal Drugs that may Improve Bone Marrow Transplant
Compounds boost stem cell engraftment; could allow more matches for patients with cancer and blood diseases.
Teeth Reveal Lifetime Exposures to Metals, Toxins
Researchers have identified dental biomarkers to reveal links between early iron exposure and late life brain diseases.
An Innovative Algorithm to Decipher How Drugs Work Inside the Body
Researchers at Columbia University Medical Center (CUMC) have developed a computer algorithm that is helping scientists see how drugs produce pharmacological effects inside the body.
Uncovering the Spread of Bacteria in Pneumonia
Northwestern Medicine scientists have discovered the role a toxin produced by a pneumonia-causing bacterium plays in the spread of infection from the lungs to the bloodstream in hospitalized patients.
Ferring Bets on Bacteriophages to Treat Inflammatory Bowel Disease
Ferring Pharmaceuticals have annoucned that it will collaborate with Intralytix in the latest phase of its early stage development programme for a bacteriophage-based therapy for inflammatory bowel disease (IBD).
Rare Form: Novel Structures Built from DNA Emerge
DNA, the molecular foundation of life, has new tricks up its sleeve. The four bases from which it is composed can be artificially manipulated to construct endlessly varied forms in two and three dimensions.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!