Extended Phase II Results of Furosemide GR(TM) in Congestive Heart Failure
Jun 4, 2005 - 11:45:00 AM
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"While Furosemide GR tablets resulted in comparable total fluid output compared to immediate release furosemide, we are disappointed that the data didn't show a consistent improvement in urinary urgency and frequency as was observed in our Phase I trial in healthy volunteers."
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By Depomed, Inc.,
[RxPG] Depomed, Inc. (Nasdaq:DEPO) today announced results from its extended Phase II trial of Furosemide GR(TM), a controlled release formulation of the leading diuretic furosemide, which is used to treat edema in congestive heart failure (CHF) patients. Additional data from ten patients who underwent additional treatment indicated that Furosemide GR continued to produce comparable diuresis to immediate release furosemide, however with variable urinary urgency and frequency between the two treatment groups.
"While Furosemide GR tablets resulted in comparable total fluid output compared to immediate release furosemide, we are disappointed that the data didn't show a consistent improvement in urinary urgency and frequency as was observed in our Phase I trial in healthy volunteers," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "Even though the extended study involved follow up in only ten patients from the initial Phase II trial, we believe the data warrant a re-evaluation of our pursuing a diuretic program in this patient population."
The company indicated that while it is re-evaluating the program, resources that were dedicated to Furosemide GR development will be reallocated to grow its pipeline with new programs as well as support its other late stage programs, including two products, Glumetza(TM) and Proquin(TM) XR, both under review at the FDA, and another product, Gabapentin GR(TM), currently in Phase II clinical testing. The company may choose to conduct additional development of Furosemide GR in a different patient population at a later time.
In September 2004, the company reported results from a Phase II clinical trial which involved 30 CHF patients to compare Furosemide GR to immediate release furosemide. The data showed comparable diuresis between the two treatment groups, but inconsistent results related to urinary urgency and frequency. The extended Phase II program was designed to evaluate potential differentiation of Depomed's controlled release product compared to the immediate release product, particularly related to urinary frequency and urgency.
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 Depomed has characterized as the "Niagara effect," that may lead to poor patient compliance. Depomed's Furosemide GR is a once daily, controlled release formulation of furosemide intended to achieve a moderated and gradual diuretic effect.
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Additional information about the news article
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About Depomed
Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) 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. Regulatory applications for once daily Glumetza(TM) (Metformin GR) for the treatment of Type II diabetes have been submitted to agencies in the U.S. and Canada. Depomed has been notified that the NDA for Glumetza is approvable. In addition, an NDA has been submitted to the FDA for once daily Proquin(TM) (ciprofloxacin HCl extended-release tablets) for the treatment of urinary tract infections. The company is also conducting a Phase II trial with the pain 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 pre-clinical 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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