New Analyses of Safety and Efficacy Data of Depomed's Gralise to be Presented at the 63rd Annual Meeting of the American Academy of Neurology
MENLO PARK, Calif., Apr 12, 2011 (GlobeNewswire via COMTEX) -- Depomed, Inc. (Nasdaq:DEPO) today announced that two new analyses of phase 3 clinical data of Gralise(TM) (gabapentin), a once-daily evening formulation of gabapentin for management of postherpetic neuralgia (PHN), will be presented this week at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu, Hawaii. A poster to be presented this evening concludes that there was no effect of previous treatment with gabapentin and pregabalin on the efficacy or adverse event (AE) profile of Gralise. An oral presentation to be given Thursday evening will review the overall tolerability and safety dataset from two phase 3 clinical trials of once-daily Gralise. Gralise was recently approved by the U.S. Food and Drug Administration and will be available in pharmacies in the fourth quarter of 2011.
"These analyses of the Gralise phase 3 trial data support the efficacy and safety profile of Gralise, which was similar regardless of prior treatment with gabapentin or pregabalin," said Michael Sweeney, MD, Vice President of Research and Development for Depomed.
-- "Effect of Prior Exposure to Immediate-Release (IR) Alpha 2 Delta (α2δ) Ligands on the Efficacy and Adverse Event Profile of Gabapentin Once-Daily for the Treatment of Postherpetic Neuralgia (PHN)" (Poster presentation P03.001, Tuesday, April 12, 2:00 to 6:30 pm, Hawaii-Aleutian Standard Time)
Dr. Sweeney will present this post-hoc analysis, conducted to determine whether previous exposure to immediate-release formulations of α2δ ligands (gabapentin and pregabalin) influenced the efficacy and AE profile of Gralise. The analysis included 257 patients recruited in the U.S., 117 treatment naïve patients and 140 with previous exposure to α2δ ligands. Efficacy for the naïve and prior treatment groups was similar. The overall incidence of AEs was 54% for the treatment naïve group and 66% for the prior treatment group, compared to 40% and 46% in the corresponding placebo groups. The incidence of dizziness and somnolence were 7.1% and 5.4% (placebo 0% and 3.2%) in the treatment naïve group and 14.1% and 8.5% (placebo 0% and 2.9%) in the prior treatment group. The researchers concluded that Gralise had similar efficacy and AE profiles regardless of whether patients were treatment naïve or treatment experienced.
-- "Tolerability and Safety of Once-Daily Gabapentin in the Treatment of Postherpetic Neuralgia" (Oral Presentation S59.003, Thursday, April 14, 3:30 p.m., Hawaii-Aleutian Standard Time)
Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, and Clinical Associate Professor, University of Washington Medical School in Seattle, Washington, will present the tolerability and safety results pooled from two 11-week phase 3 clinical trials of Gralise. In total, 722 patients with PHN and Average Daily Pain (ADP) greater than or equal to 4 on the 11-point Likert Scale for greater than or equal to 3 months were enrolled and included in this analysis. Patients were assigned to Gralise 1800 mg once-daily (n=357) or to placebo (n=365). Patients were 43% male and had a mean age of 66 years.
Treatment-emergent AEs were reported in 48% of patients (54% in the Gralise group vs. 42.3% in the placebo groups) and led to discontinuation in 8% (9.7% vs. 6.9%). The most frequent AEs (reported by greater than or equal to 3% of patients) were dizziness (10.9% vs. 2.2%), somnolence (4.5% vs. 2.7%), headache (4.2% vs. 4.1%), peripheral edema (3.9% vs. 0.3%) and diarrhea (3.3% vs. 2.7%). Serious AEs were reported in 7 patients in the Gralise group (2%) and 10 patients in the placebo group (3%). There were 2 deaths, both in the placebo group. Mean values for laboratory parameters and vital signs at the end of each study were similar between groups. In addition, the researchers analyzed rates of dizziness and somnolence in patients younger than 65 years of age or 65 and older. Similar rates of these AEs were seen in younger and older patients.
"The once-daily formulation of gabapentin, Gralise, was well tolerated and rates of discontinuations due to adverse events were low, 9.7% compared with 6.9% on placebo," said Dr. Irving.
About Postherpetic Neuralgia
PHN is a persistent neuropathic pain condition caused by nerve damage after a shingles or herpes zoster viral infection and afflicts approximately one in five patients diagnosed with shingles in the United States. The incidence of PHN increases in elderly patients, with 75 percent of those over 70 years old who have shingles, developing PHN. The pain associated with PHN reportedly can be so severe that patients are unable to resume normal activities for months. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
Important Safety Information
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.
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and another recently approved product. Gralise(TM) (gabapentin) is a once-daily treatment approved for the management of post-herpetic 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 controlled release of medications to the upper gastrointestinal tract when dosed with food. Additional information about Depomed may be found on its website, http://www.depomed.com.
The Depomed, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7529
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 by Depomed that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Depomed's business, including, without limitation: risks related to the launch of Gralise(TM); and other risks detailed in Depomed's prior press releases and 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 does not undertake 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.
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SOURCE: Depomed, Inc.
CONTACT: Sheilah Serradell Depomed, Inc. (650) 462-5900 firstname.lastname@example.org
Posted: April 2011