NuPathe, Inc. (PATH) stock is dropping hard in pre market this morning after the FDA rejected their Migraine Patch. Shares of NuPathe, Inc. (PATH) are down 53% to $1.96 in early trading today.
FDA Requests Additional Information Regarding NuPathe's Migraine Patch in Complete Response Letter
August 30, 2011 -- NuPathe Inc. (NASDAQ: PATH) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for its migraine patch (NP101 or Zelrix). A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of an NDA is completed and questions remain that preclude the FDA from approving the NDA at the time.
In the CRL, the Agency acknowledged that NuPathe established the efficacy of the migraine patch in the overall migraine population. The CRL primarily contained chemistry, manufacturing and safety questions, which the Company believes it has, or shortly will have, sufficient data to address. The Company may conduct additional Phase I and/or non-clinical studies to address other questions. NuPathe will request an End-of-Review meeting with the Agency to discuss the CRL and the Company's approach to resolving the outstanding issues. The issuance of this CRL means that the Company will not launch its migraine patch in the first half of 2012, as previously announced.
"This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner," said Jane Hollingsworth, CEO of NuPathe. "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."
About Migraine and Migraine-Related Nausea
Migraine is a neurological disorder that affects approximately 30 million adults in the U.S. In addition to a debilitating headache, most migraine patients suffer from one or more significant gastrointestinal (GI) problems, including nausea, vomiting, and a compromised ability to digest, known as decreased gastric motility. A recent survey by the National Headache Foundation shows that 90% of migraine sufferers reported having experienced migraine-related nausea. The nausea and fear of vomiting associated with a migraine make it difficult for many patients to take oral medications, while reduced gastric motility may affect the efficacy of oral medications.
http://ir.nupathe.com/easyir/customrel.do?easyirid=93835B7BA787C7DA&version=live&prid=793077&releasejsp=custom_163
August 30, 2011 -- NuPathe Inc. (NASDAQ: PATH) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for its migraine patch (NP101 or Zelrix). A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of an NDA is completed and questions remain that preclude the FDA from approving the NDA at the time.
In the CRL, the Agency acknowledged that NuPathe established the efficacy of the migraine patch in the overall migraine population. The CRL primarily contained chemistry, manufacturing and safety questions, which the Company believes it has, or shortly will have, sufficient data to address. The Company may conduct additional Phase I and/or non-clinical studies to address other questions. NuPathe will request an End-of-Review meeting with the Agency to discuss the CRL and the Company's approach to resolving the outstanding issues. The issuance of this CRL means that the Company will not launch its migraine patch in the first half of 2012, as previously announced.
"This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner," said Jane Hollingsworth, CEO of NuPathe. "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."
About Migraine and Migraine-Related Nausea
Migraine is a neurological disorder that affects approximately 30 million adults in the U.S. In addition to a debilitating headache, most migraine patients suffer from one or more significant gastrointestinal (GI) problems, including nausea, vomiting, and a compromised ability to digest, known as decreased gastric motility. A recent survey by the National Headache Foundation shows that 90% of migraine sufferers reported having experienced migraine-related nausea. The nausea and fear of vomiting associated with a migraine make it difficult for many patients to take oral medications, while reduced gastric motility may affect the efficacy of oral medications.
http://ir.nupathe.com/easyir/customrel.do?easyirid=93835B7BA787C7DA&version=live&prid=793077&releasejsp=custom_163
