Proquin XRTreatment for Urinary Tract Infection
Depomed Announces Proquin XR NDA Accepted by FDA
MENLO PARK, Calif.--September 20, 2004 - Depomed, Inc. (Nasdaq:DEPO) announced today that the company's New Drug Application (NDA) for Proquin XR, a once-daily, extended-release formulation of the antibiotic ciprofloxacin, has been accepted for review (effective date September 18, 2004) by the U.S. Food and Drug Administration (FDA).
"With the acceptance of our NDA for Proquin, we now have two products currently under review for approval, positioning us to generate our first product revenue next year," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "This is a very exciting and momentous time at the company as we draw nearer to realizing our goal of providing improved medicines to patients."
Earlier in 2004, the company announced that regulatory applications for Glumetza, a once-daily, extended-release formulation of metformin HCl for the treatment of Type II diabetes, were accepted for review in the United States and Canada.
The company's Proquin XR NDA is supported by results of its pivotal Phase III clinical trial. The randomized, double-blind Phase III trial enrolled 1,037 patients with uncomplicated urinary tract infections (UTI). The trial was designed to evaluate the efficacy and safety of a three-day course of treatment with Depomed's once-daily Proquin XR compared to a three-day course of treatment with twice-daily CIPRO, an immediate release formulation. The analysis showed a microbial eradication rate of 93.4 percent in the Proquin XR arm compared with 89.6 percent with CIPRO. Overall gastrointestinal disorders, a complaint of some patients taking ciprofloxacin, were reported in 2.9 percent of patients treated with Proquin XR and 5.1 percent in patients treated with CIPRO. Notably, there were 3.5-fold fewer complaints of nausea and seven-fold fewer cases of diarrhea reported in the Proquin XR group compared to patients treated with CIPRO.
According to the American Foundation for Urological Disease, urinary tract infections result in as many as 10 million visits to physicians each year. UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Bayer's CIPRO is a leading oral antibiotic in the U.S., with sales of $1.3 billion in 2003. Depomed has utilized its proprietary Gastric Retention (GR(TM)) technology to design Proquin XR for preferential absorption in the upper intestine.
Gastric Retention Technology
Depomed's Gastric Retention (GR) System is a patented, oral drug delivery technology designed specifically for drugs that are preferentially absorbed high in the gastrointestinal tract. Using normal physiological processes by which the stomach retains large objects for further digestion, the GR System swells following ingestion and is retained in the stomach for a number of hours, while it continuously releases the incorporated drug at a controlled rate to absorption sites in the upper intestinal tract. The controlled release of the drug at the preferred absorption site optimizes delivery of the drug during the "therapeutic window," potentially maximizing its therapeutic benefits and decreasing gastrointestinal side effects. GR-based products are designed to provide once-daily administration, improving patient convenience, compliance and pharmacokinetic profiles.
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop novel oral products and improved formulations of existing oral drugs. GR-based products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Regulatory applications for once daily Glumetza (Metformin GR) for the treatment of Type II diabetes are under review at agencies in the U.S. and Canada. In addition, the company's NDA for once-daily Proquin XR (ciprofloxacin HCl extended-release tablets) for the treatment of urinary tract infections is under review at the FDA. The company is also conducting a Phase II trial with the diuretic Furosemide GR and plans to initiate a Phase II trial with the seizure and pain drug Gabapentin GR later in 2004.
For further information about Depomed, please visit www.depomedinc.com.
Posted: September 2004