As we wrote about back in March the Food & Drug Administration (FDA) did not approve the inhaled migraine treatment Levadex on the FDA “action date” for the drug’s application. Rather, at that time the FDA issued a “Complete Response Letter”, or CRL, to MAP Pharmaceuticals, the makers of Levadex.
In the CRL, the FDA asked MAP to address some issues with manufacturing processes and the FDA stated that they had not had sufficient time to complete their review of usability of the Levadex inhaler device. Levadex is an inhaled form of DHE (dihydroergotamine) being developed to treat migraine.
In a press release from MAP, the company stated that they have met with officials from the FDA, and they feel that they have clarity on what is needed to address the issues in the Complete Response letter. The company further states that it plans to resubmit Levadex to the FDA in the late third quarter/early fourth quarter 2012 timeframe.
Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals, said in a statement “We believe LEVADEX has the potential to be an important new therapy for people who experience migraine and look forward to being able to provide it to patients whose needs are not being met by currently available treatments.”
It is worth noting that the company says that it does not think that further clinical trials are necessary, suggesting that the FDA has sufficient information on the effectiveness and safety of Levadex. Only time will tell.
What does this mean? After the upcoming submission, the FDA will let MAP know whether it will require two months or six months to respond, at that time the Levadex application will be given a new “action date”. MAP will let the public know the new action date, and we in turn will let you know. So in a shortest-case scenario, Levadex could be approved later this year or early next. Of course, a resubmission is no guarantee of final approval from the FDA, but the signs from MAP seem to be encouraging.
Of course, we will continue to keep you updated on any further developments.