Antares' overactive bladder drug wins approval by FDA Print E-mail
By Staff and Wire Reports   
Thursday, 08 December 2011 09:32
Antares Pharma, Inc. (Amex:AIS) and their partner Watson Pharmaceuticals, Inc. (NYSE: WPI) have announced that the U.S. Food and Drug Administration (FDA) has approved Antares' topical oxybutynin gel 3% product for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.  OAB is a condition that affects more than 33 million Americans, and the market currently exceeds $2.0 billion annually.

Overactive bladder is characterized by a sudden, uncomfortable need to urinate with or without urge incontinence (urine leakage), and usually includes more frequent urination and nocturia (waking up at least once during the night to urinate).  It affects as many as 33 million adults in the U.S. – more than diabetes or asthma. More than an "inconvenience," OAB is disabling and associated with a marked decrease in health-related quality of life as well as higher rates of depression.  The disease affects both men and women however, women experience more severe symptoms earlier in life.

Antares' oxybutynin product is a clear, odorless topical gel available in a convenient, metered-dose pump that has demonstrated to be an effective and safe treatment for overactive bladder (OAB).  Because the active ingredient is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin.  This results in a low level of side effects, such as dry mouth and constipation. Under an exclusive licensing agreement, Watson anticipates launching the product in 2012. 

"This significant achievement represents Antares' first NDA approval and is the culmination of a development program managed successfully by our clinical and regulatory team," said Paul K. Wotton, Ph.D., Antares' President and CEO.  "Watson Pharmaceuticals' proven track record of commercializing transdermal products to urologists and other significant prescribers of OAB treatments makes them an ideal partner to execute a successful product launch."

"The addition of Antares' oxybutynin gel product will strategically enhance our overactive bladder product portfolio which currently includes GELNIQUE® (oxybutynin chloride) Gel 10%, and OXYTROL® oxybutynin transdermal system," said Fred Wilkinson, Watson's Executive Vice President, Global Brands. "With the addition of Antares' new gel formulation, we look forward to offering patients the added convenience of a novel pump delivery system beginning in 2012."

Antares oxybutynin gel 3% is a topical, translucent hydroalcoholic gel containing oxybutynin, an antispasmodic, antimuscarinic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, an 84 mg (approx. 3 mL) dose delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing significant efficacy without sacrificing tolerability. 

The approval of Antares' oxybutynin gel 3% is based on a 12-week, multi-center placebo controlled Phase 3 clinical study conducted by Antares. Patients were randomized to either an 84 mg or 56 mg dose application of oxybutynin gel 3% versus placebo.  The FDA approved the 84 mg dose application.  Patients treated with 84 mg oxybutynin gel daily achieved steady state drug concentrations within three days and experienced a statistically significant decrease in OAB symptoms versus placebo, including the number of urinary incontinence episodes per week.  Statistically significant improvements in daily urinary frequency and urinary void volume were also seen with the 84 mg dose.

Antares Pharma Inc is a specialty pharmaceutical company engaged in the development and commercialization of novel therapeutic products utilizing advanced drug delivery systems. The company was formed in 2001 after the merger of Medi-Ject Corporation and Permatec Holding AG. Their products include VIBEX(TM) MTX used for rheumatoid arthritis (RA); 3) Tjet® injector for TEV-TROPIN® brand human growth hormone; 4) Elestrin(TM) estradiol gel; 6) ZomaJet® 2 Vision; and 5) Twin-Jector® EZ II, etc.

In  addition,  Antares has a partnership with BioSante Pharmaceuticals (Nasdaq:BPAX). Both companies have a large stake in LibiGel and while BioSante has been pushing the product through development, many investors may not be aware that a patented FDA approved technology developed by Antares is a critical component in Libigel. The company’s Advanced Transdermal Delivery (ATD) Gel System offerd BioSante an ideal means to deliver testosterone in a controlled and reproducible way with a convenient to use dosage form. Antares’platform allows LibiGel to be absorbed quickly through the skin after applying a once-daily, pea-sized topical application on the upper arm. The dose delivers testosterone to the bloodstream evenly over time.


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