NuPathe said that the Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) to the company regarding the New Drug Application (NDA) for its migraine patch (NP101 or Zelrix). When the FDA’s Center for Drug Evaluation and Research completes the review of an NDA, a CRL is issued to address those queries that prevent the timely FDA approval of the NDA.
The FDA acknowledged in the CRL that NuPathe established the efficacy of the migraine patch in the overall migraine population. The company is said to have adequate data to address chief questions in the CRL related to the chemistry, development, and safety of the patch, while it may conduct additional Phase I and/or non-clinical studies to tackle further queries. In an End-of-Review meeting with the Agency, NuPathe will thrash out the CRL and clarify any outstanding issues. Due to the release of this CRL, the company will not be permitted to launch the migraine patch in the first half of 2012, as declared earlier.
CEO of NuPathe Jane Hollingsworth said, “This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner. We continue to believe that our patch will address the symptoms of millions of patients who suffer from debilitating migraine headache pain and migraine-related nausea. We look forward to working with the FDA to bring this important product to market.”