Memantine results are positive for Diabetic Neuropathy,
Wednesday January 28, 7:31 pm Eastern Time
Company Press Release
SOURCE: Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc. Reports Results From Phase II Neuropathic Pain Trial
Positive Data Support Further Clinical Development of Memantine in Patients With Painful Diabetic Neuropathy
RICHMOND, Calif., Jan. 28 /PRNewswire/ -- Neurobiological Technologies, Inc. (Nasdaq: NTIIC - news) today announced the results of its controlled human clinical trial of Memantine in patients with neuropathic pain due to diabetes or post-herpetic neuralgia (a complication of shingles). Memantine subjects with painful diabetic neuropathy experienced greater pain relief and reduction in pain intensity compared to the placebo comparator. On average, diabetic patients treated with Memantine experienced an 18% reduction in daytime pain and a 30% reduction in nocturnal pain, as well as having 29% greater pain relief compared to placebo. No significant differences from placebo were observed in the post-herpetic neuralgia patients dosing with Memantine. In this trial, Memantine was generally well-tolerated and patients had no serious side effects.
Of a total of 122 patients enrolled in this trial, approximately 60% had diabetic neuropathy and 40% had post-herpetic neuralgia. Data were analyzed separately for these two groups of patients. After eight weeks of treatment, the diabetic neuropathy patients taking Memantine showed statistically significantly less nocturnal pain compared to the placebo group (p<0.10), as well as a trend for greater pain relief and less daytime pain.
Paul Freiman, president and chief executive officer, said, ''This clinical trial outcome is a unique milestone for the company, and I expect it to generate considerable interest in the pharmaceutical community. We are now in negotiations with potential partners regarding collaborations. The trial confirms our belief that Memantine, a neuroprotective agent, is well-suited to treat this chronic pain because of its oral availability and favorable side effect profile. Patients treated for painful diabetic neuropathy overwhelmingly represent the largest market opportunity, outnumbering post-herpetic neuralgia patients by nine to one.''
Ronald Goldblum, MD, vice president of medical affairs, said, ''We are encouraged by the results in the diabetic neuropathy treatment group. Many of the estimated 800,000 treated diabetic neuropathy patients in the United States do not obtain adequate pain control from existing therapies. The trend we observed in this trial indicates Memantine's effectiveness in relieving this type of neuropathic pain. Since 40% of patients in the trial had post-herpetic neuralgia, the number of diabetic neuropathy patients utilized for statistical analysis was decreased considerably. Nevertheless we consider these results a positive indication of Memantine's potential as an analgesic. As we anticipated, we will next prepare to undertake, a larger clinical trial. In view of these results, we will now conduct this trial exclusively in patients with painful diabetic neuropathy. To finalize the design of this trial, we will work with appropriate thought leaders and the Food and Drug Administration.''
''It has been rewarding to have participated in this trial of Memantine,'' said Jack Klapper, MD, trial investigator from the Colorado Neurology and Headache Center. ''There is an urgent need to develop effective treatments for chronic, neuropathic pain, a relatively common complication of diabetes. As diabetic neuropathy progresses, neuropathic pain becomes increasingly difficult to treat with currently available analgesics such as anti-depressants and opioids. Many of my patients obtained significant clinical and quality of life benefits from Memantine after responding poorly to existing treatments.''
Paul Freiman further stated, ''In light of these results, we will now reassess and focus our drug development plans to streamline our strategies for the company's future. In addition to our program to develop Memantine for neurepathic pain, we are also collaborating with the National Institutes of Health to evaluate Memantine in a Phase II trial for treatment of dementia and neuropathic pain symptoms in AIDS patients. We believe that this is another drug development opportunity where a neuroprotective agent could significantly improve the quality of life for a large and underserved patient population.'' |
