Add to balance / Manage account | User: | Log out |
Prospect News home > News index > List of issuers A > Headlines for Avigen, Inc. > News item |
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.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.