Gabapentin GR - DPN

Gabapentin GR® is an investigational formulation of gabapentin, an FDA-approved immediate release pharmaceutical for the treatment of partial epilepsy and management of postherpetic neuralgia. Depomed is currently developing Gabapentin GR, an AcuForm™-enhanced formulation, administered once- or twice-daily for the treatment diabetic peripheral neuropathy (DPN).

DPN is a peripheral nerve disorder caused by diabetes.  Approximately 60 percent to 70 percent of the 20 million diabetics in the United States have mild to severe forms of nervous system damage. After a period of inadequate glycemic control, nerve damage may occur and may lead to a number of health problems, including indigestion, diarrhea or constipation, dizziness, bladder infections and impotence. DPN is often associated with numbness, pain, or tingling in the feet or legs and may lead to weakness in the muscles of the feet.

Leveraging AcuForm Technology

Formulated with AcuForm delivery technology, Gabapentin GR is designed for targeted, controlled release to the upper GI tract over a six to eight hour period. This extended release allows for the drug to be gradually absorbed into the blood, reducing the likelihood of peak concentrations and potentially resulting in fewer side effects than seen with immediate release formulations. Greater treatment tolerability and a more convenient dosing regimen made possible with AcuForm could potentially translate into greater patient compliance and ultimately better pain management.

Clinical Results and Development Status

In December 2006, Depomed announced positive results from a Phase 2 clinical trial of Gabapentin GR for the treatment of DPN.

The Phase 2, multicenter, double-blind, placebo-controlled clinical trial involved 147 patients with DPN. Patients were randomized into one of three treatment groups for the four-week treatment period: placebo and 3000 mg total daily dose of Gabapentin GR administered once- and twice-daily. Data from the trial demonstrated a statistically significant reduction in pain and sleep interference scores with Gabapentin GR administered once-daily (3000 mg total/day):

There were no serious adverse events associated with Gabapentin GR. The most common side effects observed were dizziness and somnolence, which are commonly associated with gabapentin.

Please visit other pages on this section of the website to learn about Gabapentin GR in clinical development for the treatment of postherpetic neuralgia and menopausal hot flashes.

The data referenced in the preceding paragraphs represent the most recently announced data pertaining to this program. For data from earlier trials, please refer to the press release section of this website.