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

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
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 2,800+ scientific posters on ePosters
  • More than 4,000+ 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 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
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Personalized Drug Screening for Multiple Myeloma Patients
A personalized method for testing the effectiveness of drugs that treat multiple myeloma may predict quickly and more accurately the best treatments for individual patients with the bone marrow cancer.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
Cancer-Fighting Tomato Component Traced
The metabolic pathway associated with lycopene, the bioactive red pigment found in tomatoes, has been traced by researchers at the University of Illinois.
Batten Disease may Benefit from Gene Therapy
NIH-funded animal study suggests one-shot approach to injecting genes.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.
Molecule Proves Key to Brain Repair After Stroke
Scientists found that a molecule known as growth and differentiation factor 10 (GDF10) plays a key role in repair mechanisms following stroke.
Towards Patient-Specific Drug Screening
A new breakthrough by the 3D stem cell printing team at Heriot-Watt could pave the way to individually tailored drug testing regimes, both reducing the need for animal testing and ensuring that patients receive drugs which are most effective for their individual needs.
Antibody Targets Key Cancer Marker
University of Wisconsin-Madison researchers have created a molecular structure that attaches to a molecule on highly aggressive brain cancer and causes tumors to light up in a scanning machine.
Gut Bacteria Can Dramatically Amplify Cancer Immunotherapy
Manipulating microbes maximizes tumor immunity in mice.

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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos