Arbaclofen extended-release (ER) tablets taken twice a day can effectively reduce spasticity (muscle stiffness) in patients with multiple sclerosis (MS) with similar potency to that of standard and more-frequently-dosed baclofen (brand name Lioresal), Phase 3 clinical trials show.
Latest trial data were presented in two posters during the 33rd Annual Meeting of the Consortium of Multiple Sclerosis Centers that was held in Seattle, Washington.
Approximately 60–90% of MS patients experience spasticity, a symptom characterized by uncontrolled stiffness and contraction of muscles. Spasticity can be mild or severe, causing painful spasms, and being a main cause of morbidity in these patients. To prevent the deterioration of knees, shoulders, ankles, elbows, and hips, appropriate treatment is necessary.
Spasticity is frequently treated with baclofen (among other names), an approved therapy available in different forms that acts as a muscle relaxant and an anti-spastic agent. However, its therapeutic doses may cause unwanted side effects in the central nervous system, which affect patients’ adherence to the treatment.
Arbaclofen ER tablets (brand name Ontinua), developed by Osmotica Pharmaceuticals, distributes the therapy’s active ingredients over time in the patient’s body, allowing for less-frequent dosing and likely decreasing the risk of systemic adverse side effects.
Researchers conducted a Phase 3 clinical trial (identified as OS440-3002, NCT01743651) across several clinical centers in the U.S., Russia, and Ukraine to compare the effectiveness and safety of arbaclofen ER with baclofen in patients with spasticity due to MS.
The study included 341 MS patients, the majority having relapsing-remitting (57.5%) or secondary progressive MS (38.4%), followed by 2.6% with primary progressive MS, and 0.9% who had progressive-relapsing MS.
Participants were randomized into three groups to receive two daily doses of 20 mg of arbaclofen ER, the same dose of baclofen given four times a day, or a placebo. Each therapy was given at increasing doses over two weeks, followed by 12 weeks of maintenance treatment.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?