There is new news regarding a widely-used treatment for Relapsing-Remitting Multiple Sclerosis. According to the latest reports released by Teva Pharmaceutical Industries, the FDA has approved the company’s concentrated 3-times-per-week formulations of Copaxone, and that the formulation will now be available in 40 mg dosages. This new formulation strategy will decrease the dosing frequency of Copaxone (or glatiramer acetate) by 60% per week (from once daily sub-cutaneous injections to thrice weekly formulations).
Israel-based Teva Pharmaceutical Industries stated that the 20 mg formulations of Copaxone will also be available in addition the new 40 mg concentrated injections.
Details of Study and background of Copaxone:
After initial studies, the FDA approved Copaxone in the form of sub-cutaneous injections given once daily in a dose of 20 mg/day. However, the GALA trial conducted in 2012 explored the benefits, safety, and efficacy of a high dose of Copaxone in the study participants. The randomized, placebo-controlled trial tested the thrice weekly, 40 mg per dose regimen against placebo via sub-cutaneous injections and identified that the rate of relapse in test group reduced by 34%. In addition, the lesions on MRI were reduced by 35% as compared to control group.
The study concluded that the therapeutic benefits of a concentrated 40 mg thrice weekly regimen are comparable to the 20 mg once daily regimen, with better patient compliance and convenience. No safety concerns were identified by the research team.
In May of 2013, Teva Pharmaceuticals announced that the FDA had approved the supplemental New Drug Application (sNDA) to consider the low frequency, high concentrated Copaxone regimen. Now, since the FDA has approved the 40 mg concentrated injections, patients can speak to their healthcare provider about trying out the new regimen.
Copaxone is a preferred therapy for the management of relapsing/ remitting variety of multiple sclerosis. The active ingredient, glatiramer acetate, exerts its actions by acting as a protein to prevent the hyperactive immune cells from attacking neurological cells and nerves in brain and spinal cord. Copaxone acts as an immunomodulator by reducing the intensity and frequency of multiple sclerosis episodes.
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About Multiple Sclerosis:
Multiple sclerosis is an autoimmune condition in which hyperactive immune cells begin to attack the myelin sheath of nerves. The loss of insulation affects the speed of nerve conduction and leads to slowly progressive disease that leads to deleterious results. Early symptoms of MS include double vision, weakness of muscles and reflexes, tingling, numbness that further progress to muscle stiffness, cognitive decline and psycho-social issues in advanced cases.