Osmotica Opens Phase 3 Trial On MS Drug
Wilmington-based Osmotica Pharmaceutical has begun recruiting volunteers for a Phase 3 clinical trial to assess the safety and efficacy of its experimental multiple sclerosis drug.
The drug, Arbaclofen Extended Release Tablets, is for MS patients suffering spasticity, the involuntary muscle stiffness or spasms that affect some 80 percent of those with MS.
Praveen Tyle, Ph.D., executve vice president and chief scientific officer, said the trial “marks a critical phase in the history of our company. The need for control of these symptoms and treatment via oral route medication is very critical in the management of patients with multiple sclerosis”
The trial will enroll about 300 people age 18 to 65 into a multicenter randomized double-blind study in the United States and Eastern Europe.