MAP Pharma's New Drug Application for Levadex Accepted for Review
The Food & Drug Administration (FDA) has accepted MAP Pharmaceuticals' new drug application (NDA) petition for Levadex for review. Levadex is an inhaler-based delivery mechanism for an existing migraine treatment medication called DHE.
DHE, which stands for dihydroergotamine, is a member of the ergot family of drugs. It is an older migraine treatment medication (introduced in 1945) than the more recently introduced triptan family of medications (Imitrex, Relpax, etc.). It is currently available to patients in nasal spray form (brand name Migranal) and on a more limited basis by intramuscular injection. Doctors can also give it by IV in the clinic or hospital setting. Levadex would offer a new delivery method for patients to be able to use DHE for treatment of acute migraine attacks at home. MAP Pharmaceuticals says patients using their inhaler experience fewer side effects than patients using other available forms of DHE, especially nausea and bad aftertaste, and get quick relief.
For a drug to become available to patients, the Food and Drug Administration (FDA), which is an agency of the federal government, must approve it and issue its manufacturer a license for a particular use. After completing the first three phases of the clinical trial process, the pharmaceutical company files a new drug application (NDA) to start the approval process.
The purpose of the NDA is to provide the FDA with sufficient information to determine if the drug is safe and effective, the adequacy of the package insert and whether the manufacturing standards will ensure safety and consistency. The information in the NDA tells the FDA what happened during the first three phases of clinical trials on animals and humans, how the drug affects the patient's body, what side effects were found and what the medication contains. Within 60 days the FDA must decide whether to accept the petition for review or reject it for being incomplete.
Once the petition is accepted for review, the FDA's team of physicians and scientists will review the data submitted by the MAP Pharmaceuticals in its NDA for Levadex. The FDA team will look for weaknesses in the manufacturer’s data and decide whether the conclusions the company made in its application are correct. Although this is understandably a labor and time intensive process, the FDA says its goal is to review and act on at least 90% of new drug application petitions within 10 months of the filing date.
If the FDA team decides the drug’s benefits outweigh its risks, they will approve it for use by patients for a particular purpose. If the FDA teams finds itself unable to make a decision on the available data, sometimes the FDA team will ask for additional information to help make the decision. A drug may end up going through a number of review cycles in order to address all of the concerns raised by the FDA team. If the company is ultimately unable to correct the problems that have kept the drug from being approved, the FDA will deny the NDA petition. If the pharmaceutical company later wants to have the drug approved for an additional purpose they will need to go through the approval process again for that use.
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