FDA Approves Once-daily Version of Ciprofloxacin for Treating Urinary Tract Infections
May 20, 2005, 17:54, Reviewed by: Dr.
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"Proquin XR is a new, once-daily version of ciprofloxacin that caused fewer incidences of gastrointestinal side effects, including nausea and diarrhea, in the recent multicenter Phase III clinical trial of over 1,000 patients."
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By Depomed, Inc.,
Depomed, Inc. (Nasdaq:DEPO) announced today that it has received approval from the United States Food and Drug Administration (FDA) for Proquin(TM) XR, a once-daily, extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections (UTIs).
Proquin XR is the first version of ciprofloxacin with nausea and diarrhea listed as "uncommon" adverse events in its label, rather than "common" adverse events. As a class of compounds, ciprofloxacin and other fluoroquinolones are cited in literature as causing nausea and diarrhea and these types of side effects are reportedly the most frequent reason that patients discontinue ciprofloxacin treatment.
"Urinary tract infections result in an estimated 10 million doctor visits each year, and the most frequently prescribed drug is ciprofloxacin," said Neal Shore, M.D., medical director, Carolina Urologic Research Center. "Proquin XR is a new, once-daily version of ciprofloxacin that caused fewer incidences of gastrointestinal side effects, including nausea and diarrhea, in the recent multicenter Phase III clinical trial of over 1,000 patients."
According to Depomed's own dissolution studies, CIPRO(R) and generic equivalents release their entire dosage within approximately 30 minutes and even once-daily CIPRO XR releases its dosage within approximately two hours, while Proquin XR is designed to gradually release the drug over six hours.
This extended release avoids large quantities of drug being dumped into the patient's intestinal system, where it can cause side effects or interactions with gastrointestinal drugs. In a randomized, double-blind, Phase III clinical trial of 1,037 patients with uncomplicated UTIs, Proquin XR eradicated the bacteria most commonly responsible for causing UTIs comparably to twice-daily CIPRO.
"Proquin XR is Depomed's first FDA approved product, and it is a testament not only to the benefits of our Gastric Retention (GR) extended-release drug delivery system, but to our scientific and regulatory teams," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "This approval precedes next month's anticipated FDA decision regarding the New Drug Application seeking approval for Glumetza(TM) for the treatment of Type II diabetes. We are now well on our way to generating our first product revenue and realizing our goal of providing improved medicines to patients."
Depomed's New Drug Application for Proquin XR was submitted in July 2004, just four years after Depomed initiated development of this novel formulation of ciprofloxacin. The market for ciprofloxacin is estimated at $1.5 billion worldwide in the U.S., with prescriptions for uncomplicated UTI's representing a significant portion of usage. Depomed is currently in the final stages of negotiations with potential marketing partners for Proquin XR.
About Proquin(TM) XR
Proquin XR is a once-daily extended-release formulation of ciprofloxacin hydrochloride and is intended to treat uncomplicated urinary tract infections (UTIs).
UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Patients should not take Proquin XR if they are allergic to, or have ever had a severe reaction to, ciprofloxacin or to any other "quinolone" antibiotics.
Proquin XR is generally well tolerated. The most common side effects with Proquin XR include vaginal yeast infection and headache.
Gastric Retention Technology
Depomed's Gastric Retention (GR)(TM) 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 is intended to optimize delivery of the drug during the "therapeutic window," potentially increasing its therapeutic benefits and potentially decreasing gastrointestinal side effects. GR-based products are designed to provide once daily administration, and potentially improve patient convenience, compliance and pharmacokinetic profiles. 
- U.S. Food and Drug Administration (FDA)
www.depomedinc.com
For additional information on Proquin XR, please call the product information hotline at 800-206-2945.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR) system to develop novel oral products and improved, extended release 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. Once daily Proquin(TM) XR (ciprofloxacin hydrochloride) extended-release tablets for the treatment of uncomplicated urinary tract infections has been approved by the FDA, and regulatory applications for once daily Glumetza(TM) (metformin GR) for the treatment of Type II diabetes are pending in the U.S. and Canada. The company is also conducting a Phase II trial in post herpetic neuralgia with the drug Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to our research and development efforts, including preclinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Annual Report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contacts
Depomed, Inc.
Sylvia Wheeler, 650-462-5900
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