Antares Pharma (AMEX: AIS), announced that a Special Protocol Assessment has been completed with the U.S. Food and Drug Administration (FDA) for the Pivotal Efficacy Trial of Anturol for the treatment of overactive bladder. A Special Protocol Assessment documents the FDA’s agreement that the design and planned analysis of the trial adequately addresses objectives in support of a regulatory submission such as a New Drug Application (NDA).
The randomized, double-blind, open-label, parallel, placebo controlled, multi-center trial will evaluate the efficacy of Anturol when administered topically once daily for 12 weeks predominantly in patients with urge incontinency episodes. The trial is expected to enroll up to 600 patients (200 per arm) using two dose strengths of Anturol (selected from the Phase II clinical trial) vs. a placebo. The primary end point of the trial will be efficacy against the placebo defined as the number of urinary incontinence episodes experienced. Secondary end points include changes from baseline in urinary urgency, average daily urinary frequency, patient perceptions as well as safety and tolerability including skin irritation.
Jack E. Stover, President & CEO said, “We are delighted that the FDA has completed the Special Protocol Assessment and we can initiate our pivotal trial with confidence. Moving forward into the trial with our proprietary product Anturol is a very important milestone for our product and our platform.”
OAB affects more than 20 million adults in the U.S. (and 100 million worldwide) and is one of the fastest growing segments in the urology market. It is characterized by involuntary muscle contractions resulting in urine leakage. Symptoms include urinary frequency, urgency and urge incontinence. While OAB may occur at any age, it is most common among the elderly, affecting up to 61% of those over 65, particularly post-menopausal women. A recent SCRIP Report showed the incontinence market growing at 40% per year.
Treatment for OAB currently consists of oral administration of compounds such as oxybutynin, Tolterodine, darifenacin, solifenacin, and trospium each of which have significant side effects, including dry mouth (seen in 70% of patients), nausea, dry eyes, and constipation. It is estimated that half of the adults suffering from OAB either are too embarrassed to discuss their symptoms or are not aware that pharmacological treatment is available. It is estimated by Cowen & Co. in their March 2006 publication that just 16% of incontinence patients were compliant with their treatment in 2005 and expected to improve modestly to only 18% in 2010.
Advanced Transdermal Delivery Systems (ATD™)
The ATD drug delivery platform is dedicated to the development of gels that offer a cosmetically superior option to patches, while delivering medication efficiently with less potential for skin irritation, minimizing gastrointestinal impact, as well as, the first-pass liver metabolism effect of many orally ingested drugs. Antares’ ATD gels are hydro-alcoholic and contain a combination of permeation enhancers to promote rapid drug absorption through the skin following application typically to the arms, shoulders, abdomen or thighs. The Company’s transdermal ATD gel system provides the options for delivering both systemically (penetrating into and through the subcutaneous tissues and then into the circulatory system) as well as locally (e.g. topically for skin and soft tissue injury, infection and local inflammation). Typically, the gel is administered daily, and is effective on a sustained release basis over approximately a 24-hour period of time.
About Antares Pharma
Antares Pharma is a specialized pharma product development company committed to improving pharmaceuticals through its patented drug delivery systems. Antares has three validated drug delivery platforms: the ATDTM Advanced Transdermal Delivery system, subcutaneous injection technology platforms including both VibexTM disposable mini-needle injection device and ValeoTM/Vision® reusable needle-free injection devices; and Easy TecTM oral fast-melt technology. Two of the platforms have generated FDA approved products. Antares Pharma leverages its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. The Company’s products are engineered to improve safety and efficacy profiles by minimizing dosing and reducing side effects while enabling improved patient compliance. Antares Pharma has corporate headquarters in Ewing, New Jersey, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapolis, Minnesota and Basel, Switzerland.
Safe Harbor Statement
This press release contains forward-looking statements, within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties, including those discussed in this release and others that can be found in the “Risk Factors” section of Antares’ Annual Report on Form 10-K for the year ended December 31, 2006 and in Antares’ periodic reports on Form 10-Q and other filings made with the Securities and Exchange Commission. Antares is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. No forward-looking statement can be guaranteed and actual events and results may differ materially from those projected. Forward-looking statements, including statements regarding the timing of product sales, market estimates and market potential provide Antares' current expectation or forecasts of future events. Antares' results could differ materially from those reflected in these forward-looking statements due to decisions of regulatory authorities, Antares' ability to execute on its development plans and general financial, economic, regulatory and political conditions affecting the pharmaceutical industry generally.