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news.US-based biopharmaceutical company XenoPort has announced plans to initiate an exploratory Phase II clinical trial of XP19986 in patients with acute back spasms, which is a debilitating condition affecting approximately two-thirds of patients experiencing lower back pain.
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XenoPort intends to initiate this two-week, multi-center, double-blind, placebo controlled trial in the fourth quarter of 2008. The primary objective of the study will be to evaluate the safety and tolerability of XP19986 in subjects with acute back spasms, and the secondary objectives will include the evaluation of efficacy measures and pharmacokinetics.
According to the company, XP19986 is designed to overcome certain deficiencies of baclofen, a currently marketed generic drug approved for the treatment of spasticity.
Ronald Barrett, CEO of XenoPort, said: “Following a thorough review of the current treatment options available for patients suffering from acute back spasms, we believe that XP19986 could provide an effective alternative for patients who suffer from lower back pain that is musculoskeletal in origin.
“We look forward to investigating whether XP19986 will demonstrate acceptable efficacy, safety and tolerability in this patient population where rapid relief of discomfort and return of function are critical.”