Avanir Pharmaceuticals has entered into an agreement with Medison Pharma, Ltd. for clinical research, marketing and distribution rights for Neurodex in Israel. The agreement provides for Medison to conduct clinical trials in Israel for the treatment of emotional lability in patients with multiple sclerosis (MS) and grants Medison a license to market and sell Neurodex in Israel, if it is approved for marketing.
Under the terms of this agreement, Medison will manage a Phase III clinical trial intended to examine the safety and efficacy of Neurodex in the treatment of emotional lability in MS patients. Medison will also be responsible for managing and funding all necessary regulatory registrations for Neurodex in Israel. Upon regulatory approval of the product, Medison will be the exclusive distributor of Neurodex in Israel for the treatment of emotional lability. Avanir will receive royalties on product sales if the drug is approved for marketing in that country. Financial terms of the agreement were not disclosed.
"Medison Pharma is an experienced contract research organization that has established relationships with the major MS clinics in Israel, but equally as important, Medison is well positioned to market Neurodex to the country's neurologist community," said Avanir President and Chief Executive Officer Gerald J. Yakatan. "We look forward to working with Medison and feel they will be very effective in both endeavors."
The clinical trial to be conducted by Medison is expected to run concurrently with a Phase III trial of Neurodex in MS patients with emotional lability in the U.S. These studies follow a successful Phase II/III clinical trial investigating the safety and effectiveness of Neurodex in treating emotional lability in patients with amyotrophic lateral sclerosis (ALS).
Neurodex is a patented, orally administered combination of dextromethorphan (DM) and an enzyme inhibitor and is the first drug product in clinical development specifically intended to treat emotional lability. Emotional lability, also known as pseudobulbar affect, is a symptom complex experienced by patients with neurodegenerative diseases and is characterized by uncontrollable episodes of laughter and/or crying which may be out of context to the social setting. These episodes may or may not be provoked and are not necessarily associated with the patient's underlying emotion.