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

Antares Pharma Announces Positive Results from the VIBEX QuickShot Pharmacokinetic Study

Published: Saturday, February 22, 2014
Last Updated: Friday, February 21, 2014
Bookmark and Share
Rapid restoration and consistent maintenance of steady testosterone blood levels achieved with once-weekly subcutaneous administration using the QuickShot auto injector.

Antares Pharma, Inc. has announced positive results from a multi-center phase 2 clinical study evaluating the pharmacokinetic profile of testosterone enanthate administered once-weekly by subcutaneous injection at doses of 50 mg and 100 mg using the VIBEX QuickShot auto injector in testosterone deficient adult males.

Twenty nine adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300 ng/dL were randomized into two groups. The first group received 50 mg testosterone enanthate administered subcutaneously with the QuickShot auto injector once weekly for six weeks and the second group received 100 mg of testosterone enanthate using the same device and time sequence. The clinical study followed patients for four weeks after the last dose.

The mean testosterone baseline for the 50 mg group was 214.6 ng/dL and 201.5 ng/dL in the 100 mg group. At week one, both doses produced normal mean total testosterone concentrations at 24 hours post-dose, 434 ng/dL in the 50 mg group and 572 ng/dL in the 100 mg group.

During week six of the study when patients were already at steady state pharmacokinetic conditions, the 50 mg and 100 mg groups had average plasma testosterone values within the normal range at 422.4 ng/dL and 895.5 ng/dL, respectively.

The study demonstrated rapid restoration, consistent maintenance of normal testosterone levels and dose proportionality of the 50 mg and 100 mg strengths. The once-weekly injection was generally well tolerated. No injection site pain was reported by 28 of 29 patients and seventeen patients reported mild to moderate adverse events which according to the investigators were unrelated to the drug or device. There were no deaths, serious adverse events or discontinuations due to adverse events in the study.

Paul K. Wotton, Ph.D., President and Chief Executive Officer, stated, “We are very optimistic about the potential for a self-administered, once weekly subcutaneous dose of testosterone based on the outcome of this study.”

Dr. Wotton continued, “The administration of testosterone using our proprietary QuickShot device showed that normal testosterone levels can be rapidly restored and then reliably maintained with reduced peak to trough fluctuations relative to those associated with intramuscular injections. Unlike topical treatments for males with hypogonadism, currently approved injectable forms of testosterone do not carry a black box warning for risk of transference, which has been reported to lead to abnormal development of male sexual characteristics in women and children.”


Further Information

Join For Free

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 3,500+ scientific posters on ePosters
  • More than 5,000+ 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
Insight into Eye Diseases
Scientists recreate zebrafish cell regeneration from retinal stem cells in mice.
Iron Nanoparticles Make Immune Cells Attack Cancer
Researchers accidentally discover that nanoparticles invented for anemia treatment can trigger the immune system’s ability to destroy tumor cells.
Fighting Cancer with Sticky Nanoparticles
Treatment that uses bioadhesive nanoparticles drug carriers proved more effective than conventional treatments for certain cancers.
Stem Cell ‘Heart Patch’ Almost Perfected
Scientists aiming to perfect and test 3D "heart patches" in animal model, last hurdle before human patients.
Smart Material Hunts Cancers
Team has created smart material that locates and images cancer or tumour sites in tissue.
Targeting Fat to Treat Cancer
Researchers develop novel cancer treatment that halts fat synthesis in cells, stunting tumors.
Reprogramming Lymph Nodes to Fight MS
Bioengineers work to reprogram lymph node function to fight multiple sclerosis.
Arms Race with a Superbug
Scientists have discovered that increased risk of superbug infection can be directly casued by immune system response to invading bacteria.
Genes Essential to Life Discovered
Genes critical for life are discovered in humans and mice as part of large-scale phenotyping study.
High-Capacity Nanoparticles
New type of nanoparticle can now have three or more drugs packaged within it, allowing for customised cancer therapy.
SELECTBIO

SELECTBIO Market Reports
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!