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news.Avigen has received approval from the FDA to commence its initial clinical trial of AV650, an investigational drug being developed for the treatment of disabling neuromuscular spasticity and spasm.
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Avigen is developing AV650 in the North American market under a license and supply agreement with Sanochemia Pharmazeutika AG. The compound is already marketed in Europe and Asia and Avigen’s US development program will build on safety and efficacy data gathered in these markets.
The initial clinical trial will be a phase I study to assess the safety and pharmacokinetic profile of AV650 whilst also demonstrating the lack of sedation caused by the drug in normal volunteers. Avigen plans to initiate clinical development in the second half of 2006.
“The European experience with tolperisone indicates it has the promise to provide better tolerability than current agents, and we are eager to see this demonstrated in its development in the US,” said Avigen’s president and CEO Ken Chahine. “In particular, AV650 has the potential of being non-sedative, an attribute that would clearly differentiate it from current treatments, and which we also plan to assess in this initial safety trial.”