FDA approves Avigen's planned phase 1 study of AV650 in neuromuscular spasticity, spasm

By Lisa Kerner

Charlotte, N.C., June 22 - The Food and Drug Administration approved Avigen, Inc.'s plans for a clinical trial of the New Chemical Entity, AV650.

Avigen said a phase 1 study will assess the safety and pharmacokinetic profile of AV650 in the treatment of disabling neuromuscular spasticity and spasm, often a complication of neurological disorders such as Lou Gehrig's disease and multiple sclerosis.

The orally administered centrally acting small molecule is already marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia.

"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 United States," president and chief executive officer Ken Chahine said in a company news release.

"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."

Located in Alameda, Calif., Avigen specializes in small molecule therapeutics and biologics to treat neurological disorders.

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