Tuesday March 7, 11:00 am Eastern Time
Company Press Release
SOURCE: Curatek Pharmaceuticals
BUFFALO GROVE, Ill., March 7 /PRNewswire/ -- Curatek Pharmaceuticals today announced that it has begun Phase III human clinical trials with topical clonidine gel, an innovative treatment for peripheral neuropathic pain, including widespread and frequently debilitating conditions where current treatments are often ineffective.
"Countless numbers of patients today suffer from intractable neuropathic pain that not only causes severe discomfort, but in many cases even prevents them from performing basic tasks such as walking or using their hands,'' said Dr. Robert Borgman, president of Curatek. "Based on the results of clinical studies to date, we believe this new approach to therapy offers the potential to become an important solution for a currently unmet clinical need.''
The new treatment is an innovative topical gel formulation of clonidine that has been designed to provide concentrated, site-specific therapy over the complete painful area without blocking motor or sensory nerve function. In initial clinical trials, it was associated with minimal side effects and was found effective where other treatments had failed.
In the new multi-center, double-blind, controlled clinical trials, the novel treatment is being studied for two of the most common forms of peripheral neuropathic pain, painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN). Peripheral neuropathic pain is estimated to affect up to 4 million Americans, and has also been associated with cancer, spinal cord injury, causalgia, multiple sclerosis, postamputation, stroke, HIV and tic douloureux.
Diabetic neuropathy affects approximately 10 percent of diabetics as a result of injury to peripheral nerves of the feet and legs, causing pressure-sensitive pain that renders many unable to walk. Postherpetic neuralgia is the chronic and disruptive pain that often follows reactivation of herpes zoster, commonly known as shingles, which is especially prevalent among the elderly.
While clonidine has been widely prescribed in oral form or as a transdermal patch for the treatment of hypertension, it has also been shown to act as a potent local analgesic. Because its effect is concentration-dependent, however, the compound does not provide analgesia at the site of pain when administered orally.
Moreover, when delivered via transdemal patch, clonidine produces analgesia in only a narrow band with poor pain relief in areas not covered by the patch. In addition, the systemic concentrations of clonidine produced by the transdermal patch may result in systemic side effects, including dry mouth, drowsiness, fatigue, headache, lethargy and sedation, insomnia, dizziness, impotence, dry throat, constipation, nausea and change in taste.
"The new topical clonidine gel formulation is easily spread to permit the analgesic properties to reach all of the affected painful nerves, while resulting in minimal blood levels to avoid systemic side effects,'' Dr. Borgman said. "Although its precise mechanism of action is unknown, it is believed that site-specific concentrations of clonidine may decrease the local release of norepinephrine, an agent that stimulates sensitized nerve fibers to cause painful sensations.''
The new 600-patient clinical trials will be conducted at 20 study centers around the country. Pending successful results of the multi-center clinical trials, the company plans to submit a New Drug Application (NDA) for review by the U.S. Food and Drug Administration for approval to market the new prescription therapy in the United States.
Curatek is a research-based company that develops and markets specialty pharmaceutical products for endocrinology, neurology, anesthesiology, dermatology and other therapeutic areas.
SOURCE: Curatek Pharmaceuticals