Healthcare Industry News: oxybutynin
News Release - January 3, 2006
Antares Completes the Phase II Clinical Trial for Anturol(TM)oxybutynin Gel for Overactive Bladder
EXTON, Pa., Jan. 3 (HSMN NewsFeed) -- Antares Pharma, Inc. (Amex: AIS ) today announced that it has completed its Phase II clinical dose ranging study of Anturol(TM), its oxybutynin Advanced Transdermal Delivery (ATD(TM)) gel for overactive bladder.
"We are pleased with the initial quality of data provided and are happy to report that the Phase II studies were completed in a timely manner and on budget as planned," said Dr. Dario Carrara, head of the Antares Pharmaceutical Group headquartered in Basel, Switzerland.
The open-label, single-period, randomized, dose-ranging trial included 48 healthy subjects while providing three different doses of Anturol(TM) over a 20 day period. Variables included accumulation of dose, dose proportionality, decay of plasma levels, tolerability and general adverse events.
"This is another significant milestone we have accomplished to broaden our pipeline of improved specialty pharmaceutical products," said Jack E. Stover, President and Chief Executive Officer of Antares. "We look forward to reporting top line data from the Phase II Anturol(TM) trial in early 2006 after follow-up and completion of data analysis."
Anturol(TM) is Antares' lead product for overactive bladder. It is patented, and Antares currently controls the worldwide rights to the product. The IND was filed with the FDA in March of 2005 and upon the successful conclusion of Phase III results, it is anticipated that Anturol(TM) will qualify for Section 505b (2) registration status. The preliminary Phase III plan has now tentatively been approved by the FDA and will include a double- blind, randomized, parallel, placebo-controlled, multi-center study evaluating the effect of 12 weeks of treatment with Anturol(TM) administered topically in patients with urge and mixed urinary incontinence. It is currently expected that the study population will be 400 patients who are administered two dose strengths of Anturol(TM), once daily, and compared to a placebo.
About Antares Pharma
Antares Pharma is a specialized pharma product development company with patented drug delivery systems and injectable device engineering capabilities. Antares' current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/Vision® reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares' product pipeline will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience.
Antares has active partnering programs with several pharmaceutical and distribution companies for a number of indications and applications, including diabetes, growth disorders, obesity, female sexual dysfunction and other hormone therapy. Its needle-free injector system is distributed in more than 30 countries for the administration of insulin and is marketed for use with human growth hormone through licensees in most major regions of the world. Licensees also market an ibuprofen gel in several major European countries. In addition, Antares Pharma is undertaking development or is conducting research on several product opportunities that it expects will form the basis of its specialized pharma program.
Antares Pharma has corporate headquarters in Exton, Pennsylvania, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The Company cautions readers that forward-looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially and which are identified from time to time in the Company's reports filed with the U.S. Securities and Exchange Commission. Antares Pharma claims the protection of the Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Source: Antares Pharma
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