Depomed Announces Acceptance of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796 (DEPO)
Depomed, Inc. (Nasdaq: DEPO) today announced that the New Drug Application (NDA) for DM-1796 was accepted by the U.S. Food and Drug Administration (FDA) for the management of postherpetic neuralgia (PHN), or pain after shingles. DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects.
"We are pleased the NDA was accepted for DM-1796. The acceptance triggers a $10 million milestone payment from our licensee," said Carl Pelzel, president and chief executive officer of Depomed. "We look forward to the approval of DM-1796, which we believe can provide significant clinical benefits to patients."
About Postherpetic Neuralgia
Postherpetic neuralgia (PHN) is a persistent neuropathic pain condition. It is caused by nerve damage after shingles, or herpes zoster, viral infection. Approximately 70,000 to 100,000 Americans are affected by PHN each year. The incidence of PHN increases in elderly patients -- 35 percent of shingles patients over 80 years old develop PHN. The pain associated with PHN can interfere with daily activities such as sleep and recreational activities and can be associated with clinical depression.
About DM-1796 (gabapentin extended release) Tablets
DM-1796 is an investigational, once-daily therapy for the management of postherpetic neuralgia. It features a unique extended release formulation which allows for the drug to be gradually absorbed into the blood. This reduces the frequency of peak concentrations commonly seen with immediate release formulations currently on the market. A reduction in the frequency of peak concentrations may result in a lower incidence of side effects. The formulation and the evening dosing regimen will allow for greater exposure of the drug during the night when patients with postherpetic neuralgia report the most pain. Treatment tolerability and a convenient dosing regimen could potentially translate into greater patient compliance and ultimately better pain management.
Additional information about Depomed may be found on its website, www.depomed.com.
SOURCE: Depomed, Inc.
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