Depomed, Inc. Announces Publication of Phase 3 Data from Gralise® (gabapentin) Clinical Trial
Published: Jul 23, 2012
MENLO PARK, Calif, July 23, 2012 /PRNewswire/ -- Depomed, Inc. (NASDAQ: DEPO) today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise® (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN). The results showed that patients treated with Gralise experienced a significant reduction (- 2.12) in their average daily pain intensity compared with placebo treated patients (-1.63; P=0.013). This difference from placebo was statistically significant after one week and continued to be superior through the duration of the study.
The published results are from a randomized, multi-center Phase III clinical study of 452 patients with PHN that evaluated the efficacy and safety of once-daily Gralise compared to placebo. Other results showed that the frequency of adverse events commonly associated with gabapentin was as follows: dizziness (11.3% vs. placebo, 1.7%), somnolence (5.4% vs. placebo 3.0%), and peripheral edema (3.2% vs. placebo, 0.4%) with differences in dizziness and peripheral edema being statistically significant. Secondary endpoints showed that 43% of patients treated with Gralise reported "much" or "very much" improvement compared to 34% of placebo treated patients (P<0.0434).
"Our research shows that patients treated with Gralise experienced significant reduction of their daily pain intensity," said Christine N. Sang, MD, MPH, director of Translational Pain Research, Brigham and Women's Hospital, Harvard Medical School. "This finding is encouraging because the pain associated with PHN has a significant impact on patients' daily lives and these results suggest that Gralise, in part because of its gastroretentive formulation, could fill an important treatment gap for patients with PHN."
The study was an 11-week double-blind, randomized, placebo-controlled Phase III clinical trial which evaluated the efficacy and safety of a once-daily gastroretentive formulation of Gralise (1,800 mg once daily) in patients with postherpetic neuralgia (PHN). The multi-center study evaluated patients with persistent pain for at least six months but not more than five years after the healing of a herpes zoster rash, with a pain intensity score of at least four on the 11-point Numerical Rating Scale (NRS) at screening.
The study's primary endpoint was change in the average daily pain intensity score from the baseline week until week 10 of the study. Secondary endpoints included change in clinician global impression of change (CGIC) and patient global impression of change (PGIC) and post hoc analyses by country.
Once-daily Gralise (1800 mg) was well tolerated in the study, with a lower incidence of common adverse events (AEs) than previously reported in other gabapentin studies. In the Phase III study, 210 patients reported AEs, 118 in the Gralise treated population, and 92 in the placebo treated group. The most common AEs reported included dizziness, headache and nausea. Ten serious AEs (SAEs) were reported, four in the Gralise treated group, and six in the placebo treated group. None of the SAEs were attributable to the study drug.
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 three approved and marketed products. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Zipsor ®(diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. Glumetza® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is commercialized by Santarus, Inc. in the United States. Depomed formulates Gralise and Glumetza with its proven, proprietary Acuform® 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.
"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 risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. 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.
August J. Moretti
Depomed, Inc. 650-462-5900
SOURCE Depomed, Inc.