Osmotica Pharmaceutical Announces Initiation of Phase III Studies with Arbaclofen ER Tablets
WILMINGTON, N.C., Dec 10, 2012 (BUSINESS WIRE) -- Osmotica Pharmaceutical announced today that recruitment has begun for a Phase 3 clinical trial designed to assess the safety and efficacy of Arbaclofen Extended Release Tablets in patients with spasticity due to multiple sclerosis (MS). Spasticity is one of the more common symptoms of MS and refers to involuntary muscle stiffness or spasms. It occurs in an estimated 80 percent of people with this disease. The primary objectives of the study are to demonstrate the efficacy of Arbaclofen Extended Release Tablets range of doses for treatment.
This clinical study is a multicenter randomized double-blind study. Osmotica expects to enroll approximately 300 subjects in this trial from age 18 to 65 years old with spasticity due to MS. The study will be conducted in the United States and Eastern Europe. "Initiation of this pivotal trial for our proprietary drug delivery technology based Arbaclofen Extended Release Tablets 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," said Dr. Praveen Tyle, the EVP and Chief Scientific Officer of Osmotica Pharmaceutical.
About Osmotica Pharmaceutical
Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products. The company uses its proprietary osmotic technology platform to develop high quality special pharmaceutical products. In addition to the products currently on the market and the Arbaclofen NDA, the company's pipeline includes numerous high-barrier-to-entry generics and other novel CNS and neurology-based therapeutic drugs.
Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.
For more information on the Company, please visit Osmotica's website at www.osmotica.com . This press release is directed to residents of the United States.
SOURCE: Osmotica Pharmaceutical Corp.
Osmotica Pharmaceutical Corp.
Darren Alkins, 910-509-0114
Executive Vice President, Corporate Development