UPDATE 1-FDA rejects NuPathe's migraine patch
Tue Aug 30, 2011 7:02am EDT
* Co says may need to do additional trials
* FDA raises issues related to manufacturing, safety
Aug 30 (Reuters) - NuPathe Inc said the U.S. health regulator rejected its experimental migraine patch and the company may need to conduct additional trials to address the issues raised by regulators.
In a complete response letter to the company, the U.S. Food and Drug Administration raised questions related to the chemistry, manufacturing and safety of the treatment, known as Zelrix, the company said in a statement.
NuPathe believes it has, or shortly will have, sufficient data to address the issues and may conduct additional early-stage and/or non-clinical studies to address other questions.
The company will also request a meeting with the FDA to discuss the letter and its approach to resolve the issues.
Migraine is a neurological disorder that affects about 30 million adults in the United States, NuPathe said.
Shares of the company closed at $4.05 on Monday on Nasdaq. (Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)