FDA Approval Announced For Neuralgia Treatment

Depomed Inc has announced that FDA has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. Gralise was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products in the United States, Canada and Mexico. The approval of Gralise triggers a milestone payment of $48 million from Abbott to Depomed.

"The approval of Gralise is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond," said Carl Pelzel, president and CEO of Depomed. "I’d like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication."

Michael Sweeney, MD, vice president of Research and Development for Depomed, added, "We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed. Further, FDA has granted GRALISE Orphan Drug status, recognizing Gralise as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved."

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% 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.

"The Gralise formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians’
treatment armamentarium," said Gordon Irving, MD, medical director of the Swedish Pain and Headache Center, clinical associate professor, University of Washington Medical School in Seattle. "Patients with PHN have long struggled to manage pain following herpes
zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects."

Gralise was approved on the basis of two phase 3 trials involving 359 patients treated with Graliseand 364 treated with placebo. Safety was
evaluated in all 723 patients and the efficacy assessment was based on the second phase 3 trial, a randomized, double-blind,
placebo-controlled study of 452 PHN patients. In this trial, Gralise achieved a statistically significant reduction in average daily pain
score compared to placebo. Patients in the study were randomized into two treatment arms: placebo or 1800 mg of gralise dosed once-daily.
Secondary objectives included an assessment of changes from baseline in sleep interference, and additional patient and clinician assessments of pain and quality of life.

A total of 359 patients with PHN have received Gralise at doses up to 1800 mg QD during placebo-controlled clinical studies. In these trials,
9.7% of patients treated with GRALISE and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the Gralise treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of Gralise-treated patients who experienced adverse reactions, the majority of those adverse reactions were either "mild" or "moderate". The most common treatment-emergent adverse events associated with Gralise treatment were dizziness (10.9% vs. 2.2% placebo), somnolence (4.5% vs. 2.7%) and headache (4.2% vs. 4.1%).

The Gralise NDA was submitted under Section 505(b)(2) of the Food, Drug and Cosmetic Act because it also references certain toxicity, safety and other data of Neurontin(R), the formulation of gabapentin initially approved by the FDA. As previously announced, GRALISE has received Orphan Drug designation.

SOURCE: Depomed