Avigen Begins European AV650 Trial

Avigen announced its Phase II trial for AV650 in the treatment of spasticity associated with multiple sclerosis (MS).

According to Avigen, the Phase II spasticity trial will evaluate the safety, tolerability and efficacy of AV650 (tolperisone HCl) in MS patients at doses up to 900 mg for one month followed by an open-label safety extension.

The double-blind, randomized clinical trial will be conducted at 25 MS centers in Europe. It will evaluate safety, tolerability, pharmacokinetics and efficacy in up to 150 MS patients suffering from spasticity.

Following a four-week double blind assessment, patients will be offered the opportunity to continue in a six-month, open-label safety assessment, the company said.

The company said it is developing AV650 for commercialization in the North American market under a license and supply agreement with Sanochemia Pharmazeutika. AV650 is considered a new chemical entity in the U.S.