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Ed. Note: The following
is a press release from Depomed, Inc.
MENLO PARK, Calif.--Feb. 14, 2005--Depomed, Inc. (Nasdaq:DEPO) today
announced that it has initiated a Phase II clinical trial to evaluate the
safety and efficacy of its Gabapentin extended release tablets to treat
patients with postherpetic neuralgia, a long-lasting pain condition
associated with nerve damage from herpes zoster, or shingles, infection.
"We are excited to have another product enter advanced-stage clinical
testing," said John W. Fara, Ph.D., chairman and chief executive officer
of Depomed. "With two products currently under review at the FDA and
nearing commercialization, we understand the importance of a steady steam
of programs which can expand our product offerings and continue to build
shareholder value."
The randomized, double-blind, placebo controlled trial is expected to
include approximately 25 U.S. sites and 150 postherpetic neuralgia
patients. The primary objective is to assess the efficacy of Gabapentin ER
twice daily compared to placebo in reducing mean daily pain scores. In
addition, the trial will evaluate other safety and efficacy parameters,
including sleep interference, a common problem of patients in pain.
"From this trial, we will gather data on Gabapentin ER's ability to
provide extended pain relief, with less frequent dosing, to patients
suffering from this chronic pain condition," said Bret Berner, Ph.D., vice
president, Product Development. "This is particularly important to provide
a more patient-friendly regimen that allows patients to stay ahead of the
pain."
In a Phase I trial involving 15 healthy volunteers, pharmacokinetic
properties of Gabapentin ER were compared to Neurontin, Pfizer's brand of
gabapentin. The data showed that Gabapentin ER has an extended, sustained
release plasma profile that is appropriate for administration twice daily
compared to the most commonly prescribed three times daily dosing with
Neurontin.
Postherpetic Neuralgia
Postherpetic neuralgia (PHN) is a persistent pain condition caused by
nerve damage during a shingles, or herpes zoster, viral infection. PHN
afflicts approximately one in five patients diagnosed with shingles. The
incidence increases in elderly patients with 75 percent of those over 70
years old developing PHN. The pain associated with PHN reportedly can be
so severe that patients are unable to resume normal activities for months.
Since there is no cure for PHN, treatments are focused on relieving pain.
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, and an NDA has
been submitted to the FDA for once daily Proquin(TM) XR (ciprofloxacin HCl
extended-release tablets) for the treatment of urinary tract infections.
The company is also conducting a Phase II trial with the diuretic
Furosemide GR and a Phase II trial with the pain drug Gabapentin GR.
Additional information about Depomed may be found at its web site, http://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.
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