FDA letter cites chemistry, manufacturing, and safety questions; company acknowledges more studies may be needed.
NuPathe saw its share price drop by more than half in before-hours trading on the NASDAQ stock market this morning after disclosing that it will have to delay the market launch of its migraine patch (NP101 or Zelrix) planned for the first half of next year, since the FDA failed to approve its NDA for the product.
The FDA issued to NuPathe a Complete Response Letter (CRL) that according to the company primarily cited chemistry, manufacturing, and safety questions, “which the company believes it has, or shortly will have, sufficient data to address.” NuPathe said it may conduct additional Phase I and/or nonclinical studies to address unspecified “other questions” raised by the agency.
The price of NuPathe shares plummeted from Monday’s closing price of $4.05 per share to as low as $1.80 before the start of trading, before rallying back somewhat, to $2.18 a share as of 9:38 a.m. ET.
NuPathe said it will request an end-of-review meeting with the FDA to discuss the CRL and how the company can resolve its outstanding issues with the agency.
“This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner,” NuPathe CEO Jane Hollingsworth said in a statement. “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.”