Depomed Initiates Phase II Trial With Once Daily Diuretic Furosemide GR

Business Wire, Jan 6, 2004

Business Editors/Health/Medical Writers

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MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 6, 2004

Study Will Use invivodata eDiary to Capture Patient Self-Report Data

Depomed, Inc. (NASDAQ: DEPO) today announced that it has begun a Phase II clinical trial under its IND for Furosemide GR(TM), a once daily, controlled-release formulation of the leading diuretic furosemide based on Depomed's proprietary Gastric Retention (GR(TM)) drug delivery system. The trial will evaluate the effectiveness of Furosemide GR as a controlled-release diuretic in alleviating the build up of fluid that is often associated with congestive heart failure (CHF). In a previous Phase I trial conducted in healthy volunteers, Furosemide GR achieved bioavailability, diuresis, sodium excretion and total fluid output comparable to that of immediate release furosemide (LASIX(R)), but with less urinary urgency and less initial frequency.

"Applying our gastric retention technology to furosemide gives us the opportunity to evaluate the efficacy of our GR System in controlling the 'Niagara Effect,' or the intense initial diuresis that makes this otherwise excellent drug an inconvenience for many CHF patients to take every day," said John W. Fara, Ph.D., Chairman, President and CEO of Depomed. "Given the encouraging results we observed in our Phase I trial, we believe Furosemide GR may offer convenient, once daily treatment of edema with less patient discomfort than immediate release furosemide. The initiation of this Phase II trial with Furosemide GR also demonstrates that Depomed continues to make significant progress with our earlier stage Gastric Retention products as well as with our pre-NDA and Phase III products."

The Phase II study is being conducted in approximately 30 congestive heart failure patients at three sites in the United States. It will evaluate the safety and effectiveness of once daily Furosemide GR compared to LASIX, an immediate release formulation, in the treatment of edema associated with congestive heart failure. Patients in the trial will use an electronic diary to record changes in urinary frequency and urgency. Supplied by invivodata, inc., the eDairies will enable Depomed to collect near real-time data directly from patients. Proven to increase patient compliance with study protocols, the invivodata eDiary system increases the quality of patient reported outcomes data. Depomed anticipates completing the Phase II trial in the third quarter of 2004.

Furosemide is a diuretic used to treat edema, a swelling due to excess fluid that is often associated with congestive heart failure, kidney diseases and liver diseases. Immediate release formulations of furosemide often result in an intense peak removal of fluid from the body, which we have characterized as the "Niagara effect," that may lead to discomfort and poor patient compliance. Depomed's Furosemide GR is a once daily, controlled-release formulation of furosemide designed to achieve a sustained and gradual diuretic effect.

Depomed's Gastric Retention (GR) Technology

Depomed's GR System is a patented, oral drug delivery technology designed specifically for drugs 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.

invivodata inc.

invivodata (http://www.invivodata.com/) combines behavioral science, information technology and clinical expertise to capture high integrity clinical trial data directly from patients. invivodata's electronic patient self-report system delivers patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that affect self-report studies. The invivodata eDiary has been used in more than 60 trials involving tens of thousands of patients and is the only eDiary system that has delivered the primary efficacy data for an FDA drug approval. invivodata inc. is a privately held company with global headquarters in Pittsburgh, PA.

Depomed, Inc.

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. Depomed has completed Phase III clinical trials with once daily Metformin GR(TM) for the treatment of Type II diabetes and once daily Ciprofloxacin GR(TM) for the treatment of urinary tract infections, and anticipates filing NDAs with both products in the first half of 2004. The Company is also conducting a Phase II trial with the diuretic Furosemide GR(TM) and plans to initiate a Phase II trial with the seizure and pain drug Gabapentin GR(TM) in the first half of 2004. Additionally, Depomed has a strong early-stage pipeline of proprietary and co-development products based on off-patent and over-the-counter drugs. Additional information about Depomed may be found at its web site, www.depomedinc.com.