Depomed Announces Positive Results of Phase II Clinical Trial for Gabapentin GR(TM) in Postherpetic Neuralgia
Wednesday January 4, 8:00 am ET
MENLO PARK, Calif.--(BUSINESS WIRE)--Jan. 4, 2006--Depomed, Inc. (Nasdaq:DEPO - News) today announced statistically significant safety and efficacy benefits of its Gabapentin GR extended release tablets to treat patients with postherpetic neuralgia, a long-lasting pain condition caused by nerve damage during a shingles, or herpes zoster, viral infection.
The randomized, double-blind, placebo controlled trial involved 158 postherpetic neuralgia patients. Patients were randomized to one of three treatment groups over four weeks of treatment: placebo and 1800 mg total daily dose of Gabapentin GR given once- and twice-daily.
Reductions in average daily pain scores were statistically significant with twice-daily Gabapentin GR from week two to the end of treatment based on the Likert pain scale. Clinically significant improvements in the score were observed with mean change from baseline to study end of -2.24 compared to -1.29 for placebo (p= 0.014). The secondary endpoint of sleep interference was also statistically significantly different with Sleep Interference Scores reduced by -2.28 with Gabapentin GR compared to -1.16 with placebo (p=.006). In addition, in the Clinical Global Impression of Change, a scale used by physicians for overall assessment of patient improvement, 52.3% of patients taking Gabapentin twice daily were "very much improved" or "much improved" compared to only 25% of the patients who received placebo.
For once daily Gabapentin GR, there was also a trend in pain improvement with a reduction in mean daily pain score of -1.93 with Gabapentin GR compared to -1.29 with placebo (p= 0.089). Sleep Interference Scores were reduced by -1.94 compared to -1.16 with placebo (p=0.048).
"As we expected, these data strongly support twice daily Gabapentin GR and are very encouraging for once daily use for the treatment of postherpetic neuralgia," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We look forward to finalizing our Phase III program to solidly position our product as a more convenient alternative for longer, more extended pain relief. We look forward to beginning pivotal trials in the first half of this year."
There were no serious adverse events associated with Gabapentin GR. The most common side effect observed was dizziness, which is commonly associated with gabapentin.
Bret Berner, Ph.D., vice president Product Development of Depomed, added, "From an efficacy standpoint, the reductions in pain reported with Gabapentin GR once- and twice- daily are comparable to reported historical data for total daily doses of 1800 to 3600 mg of Neurontin® given three- times daily. In addition, we observed sustained pain relief with Gabapentin GR without sedating patients. It is rewarding to see such strong pain relief trends in this Phase II study size and design which has given us insight to power our Phase III trials."
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 AcuForm drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Proquin® XR (ciprofloxacin hydrochloride) once daily, extended-release tablets have been approved by the FDA for the treatment of uncomplicated urinary tract infections. In addition, regulatory applications for once daily Glumetza(TM) (Metformin GR®) for the treatment of Type II diabetes have been approved in the U.S. and Canada. The company is also conducting a Phase II trial in post herpetic neuralgia with their product, Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com. |
