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news.The US Food & Drug Administration (FDA) has issued complete response letter (CRL) to NuPathe related to the new drug application (NDA) of (NP101 or Zelrix).
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NP101 is an active, single-use, transdermal sumatriptan patch being developed for the acute treatment of migraine.
The CRL includes chemistry, manufacturing and safety questions, which the company believes it has, or shortly will have, sufficient data to address.
Following the receiving of the CRL, NuPathe expects to request an End-of-Review meeting with the FDA to discuss the CRL and the company’s approach to resolving the outstanding issues.
NuPathe CEO Jane Hollingsworth said they are looking forward to work with the FDA to bring this important product to market.