Mematine for Peripheral Neropathy Pain
Tuesday September 14, 1:44 pm Eastern Time
Company Press Release
SOURCE: Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc. Completes Enrollment in Phase IIB Trial Of Memantine for Diabetic Peripheral Neuropathy
RICHMOND, Calif., Sept. 14 /PRNewswire/ -- Neurobiological Technologies, Inc. (OTC Bulletin Board: NTII - news) today announced the completion of patient enrollment in the Company's Phase IIB human clinical trial of Memantine as a treatment for painful peripheral neuropathy in diabetics. Enrollment in this trial was closed at 421 patients.
This randomized, double-blind, placebo-controlled trial is evaluating the ability of Memantine to relieve chronic pain due to peripheral neuropathy or nerve damage, particularly nocturnal pain that frequently interferes with sleep. The current trial calls for daily oral doses of Memantine or placebo for 8 weeks.
``I wish to thank Quintiles CNS Therapeutics, who jointly managed this trial with us,'' said Lisa U. Carr, M.D., Ph.D., vice president of medical affairs of NTI®. ``Quintiles helped us work with the 21 trial sites nationwide to facilitate enrollment and maintain the highest monitoring standards in obtaining relevant data pertinent to this chronic neurological condition.''
``This milestone represents a major effort for our small but dedicated team of employees and collaborators,'' said Paul E. Freiman, president and chief executive officer of NTI®. ``The Company expects to report data from this important trial by the end of 1999.''
Painful peripheral neuropathy, or pain related to damage to the peripheral nerves, is one of the most common complications of diabetes. Diabetic patients frequently experience chronic pain in the lower legs and feet with serious effects on their quality of life. Many medications are currently used to manage this type of pain, but patient response is highly variable and pain relief inadequate. The company estimates that approximately 800,000 patients in the U.S. currently receive treatment for the symptoms of diabetic peripheral neuropathy.
NTI is an emerging drug development company focused on the clinical evaluation and regulatory approval of neuroprotective drugs. The company's strategy is to in-license and develop early-stage drug candidates that target major medical needs and which can be rapidly commercialized. NTI currently has two product candidates in Phase II clinical trials. The company is developing Memantine, an orally available compound, which has potential as a neuroprotective agent for a broad range of neurologic dysfunctions, including neuropathic pain and AIDS dementia complex. Memantine has been marketed in Germany since 1989 with the labeling ``dementia syndrome.'' NTI is developing XERECEPT(TM) in the clinic as a treatment for peritumoral brain edema.
SOURCE: Neurobiological Technologies, Inc.
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