DepoMed Inc. started a Phase III study on a new formulation of Cipro, Bayer AG's tablet that snatched headlines in recent years as an anthrax antibiotic.
But DepoMed Inc., of Menlo Park, Calif., is looking at the product as a treatment for urinary tract infections (Cipro is prescribed for that indication as well).
Using its Gastric Retention System (GR) technology, DepoMed has developed a newer formulation that's dosed once daily and reportedly produces fewer, if any, adverse events in patients. DepoMed's candidate is an antimicrobial called Ciprofloxacin GR.
When applied to a drug, the gastric retention technology is designed to fool the body into thinking it has undigested food in the stomach. "You take it with a meal, the meal passes and the tablet stays behind and swells up," Thadd Vargas, DepoMed's vice president of business development, told BioWorld Today. "The stomach thinks [the tablet] is particles of food that haven't been digested, so it stays in the stomach. We can program how long we want it to stay in the stomach and deliver the drug over that period of time in a smoother, controlled fashion."
Cipro, which loses its patent later this year, is an immediate-release product given twice a day for urinary tract infections.
DepoMed's Phase III 700-patient trial is designed to evaluate the effectiveness of Ciprofloxacin GR compared to Cipro in eradicating bacterial organisms in the urine and alleviating patient symptoms associated with urinary tract infection. The trial is a randomized, double-blind study being conducted at 50 U.S. sites.
If all goes well, DepoMed believes it can file a new drug application in the first half of 2004.
Ciprofloxacin GR already performed well against Cipro in a Phase II study, according to the company. Data released last year demonstrated that Ciprofloxacin GR was comparably effective as Cipro without as many side effects.
Even though Ciprofloxacin GR is just entering Phase III, Vargas and Bret Berner, DepoMed's vice president of product development, told BioWorld Today the antimicrobial is almost in a neck-and-neck race with the company's lead candidate, Metformin GR for diabetes.
Like Ciprofloxacin GR, Metformin GR is a new formulation of something already on the market. Metformin, for Type II diabetes, is sold by Bristol-Myers Squibb Co., of New York, as Glucophage (immediate release) and Glucophage XR (once a day.)
Berner said DepoMed's Phase III for Metformin GR is due to be completed late this year. Under the best of circumstances, DepoMed and its partner, Toronto-based Biovail Corp., could launch the product in early 2005. (See BioWorld Today, May 30, 2003.)
Vargas said the company is seeking a partner for Ciprofloxacin GR. For now, DepoMed is using funds from its recent $20 million financing to pay for the Phase III. DepoMed raised the money by selling 9.3 million shares at $2.16 apiece to accredited investors. (See BioWorld Today, April 23, 2003.)
Elsewhere in the pipeline, DepoMed is poised to initiate a Phase II trial of Furosemide GR as a once-daily diuretic. Furosemide is a widely prescribed, loop diuretic anti-hypertensive drug currently sold by Aventis SA, of Paris, as Lasix, and as a generic by a number of other companies.
DepoMed's stock (MMEX:DMI) closed Tuesday at $3.80, up 25 cents.