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|Depomed Announces New Once-Daily GRALISE(TM) Now Available for After-Shingles Pain|
MENLO PARK, Calif., Oct 10, 2011 (GlobeNewswire via COMTEX) --
Depomed, Inc. (Nasdaq:DEPO) announced today that GRALISE(TM) (gabapentin) tablets are now available as a new once-daily treatment for postherpetic neuralgia (PHN), the pain following healing of the rash associated with shingles. GRALISE is available by prescription in a 30-day starter pack, which allows titration of the drug to full dose in 15 days, as well as bottles of 600 mg and 300 mg tablets. GRALISE is a proprietary formulation of gabapentin, using patented polymer technology that enables gradual release of the drug. GRALISE has a favorable safety profile. GRALISE has no branded or generic equivalent and is not interchangeable with other gabapentin products.
"A once-daily, tried and tested formulation for patients with postherpetic neuralgia is a great advance in the treatment of this condition," said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. "The tolerability and lack of potential drug-to-drug interaction with GRALISE is very important to this patient population and the physicians who treat them. I am pleased to use GRALISE in my clinical practice."
"The launch of GRALISE is a major milestone for Depomed," said Jim Schoeneck, the company's president and CEO. "Starting today, our sales force is introducing this new once-daily therapy for PHN to physicians and pharmacists. We have also received positive reactions from insurers and we expect to have broad managed care coverage."
About Post Herpetic Neuralgia
Each year, about one million Americans develop shingles, a painful viral infection caused by a reactivation of the same virus that causes chickenpox. It is estimated that up to one in five people with shingles will experience prolonged pain after shingles, known as postherpetic neuralgia or PHN. The pain can persist long after the shingles rash has healed and can disrupt sleep, mood, work and other daily activities.
GRALISE Important Safety Information
The most common adverse events occurring with GRALISE 1800 mg once daily vs. placebo are dizziness (10.9% vs. 2.2%), somnolence (4.5% vs. 2.7%), and peripheral edema (3.9% vs. 0.3%).
GRALISE is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. The safety and effectiveness of GRALISE in patients with epilepsy has not been studied. Antiepileptic drugs (AEDs), including gabapentin, the active ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Gabapentin should be withdrawn gradually. If gabapentin is discontinued, this should be done gradually over a minimum of one week.
The total number of patients treated with GRALISE in controlled clinical trials in patients with postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse events were similar across age groups except for peripheral edema, which tended to increase in incidence with age. GRALISE is known to be substantially excreted by the kidney. Reductions in GRALISE dose should be made in patients with age related compromised renal function.
For more information on GRALISE including full prescribing information, please visit www.GRALISE.com.
Depomed, Inc., is a specialty pharmaceutical company with two approved and marketed products. GRALISE (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). GLUMETZA(R) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. The company also has a robust pipeline including SERADA(R), which is in Phase 3 clinical development for menopausal hot flashes, as well as earlier stage candidates. Depomed formulates its products and product candidates with its proven, proprietary Acuform(R) drug delivery technology, which is designed to improve existing oral medications, allowing for extended release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, www.depomed.com.
Caution Regarding Forward Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that any of our plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: risks related to our ability to generate market demand and sales of GRALISE; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of GRALISE; our ability to ensure continued supply of GRALISE; reimbursement of GRALISE by third party payers; the strength and validity of our patents covering GRALISE; and other risks detailed in our public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Depomed undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Depomed, Inc.