FDA accepts for filing MAP's LEVADEX NDA.
M2 PHARMA-August 3, 2011-FDA accepts for filing MAP's LEVADEX NDA(C)2011 M2 COMMUNICATIONS
3 August 2011 - US MAP Pharmaceuticals Inc (NASDAQ: MAPP) said on Tuesday that its New Drug Application (NDA) for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the US Food and Drug Administration (FDA).
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 26 March 2012.
In accordance with the firm's collaboration deal with Allergan Inc (NYSE: AGN), the FDA's acceptance for filing of the NDA triggers a milestone payment to MAP of USD20m (EUR14.1m).
The firm's 505(b)(2) NDA submission for LEVADEX includes efficacy and safety data from the pivotal Phase III FREEDOM-301 clinical study and the open-label, safety extension which was designed to evaluate overall safety of LEVADEX over six and 12 months of exposure.
In total, more than 475 patients completed six months of treatment and more than 250 patients completed 12 months of treatment. In total, nearly 10,000 migraines were treated.
The NDA is also backed by data from a pharmacokinetics (PK) study evaluating the PK and safety of LEVADEX in smokers and non-smokers, a pharmacodynamics (PD) trial evaluating the acute effects of LEVADEX on pulmonary artery pressure, a QT trial comparing the acute effects of a supra-therapeutic dose of LEVADEX on the cardiac QT interval as measured by electrocardiogram, a safety trial in adult asthmatics and a drug interaction study assessing the impact of CYP3A4 inhibition on LEVADEX pharmacokinetics.
There were no drug related serious adverse events reported in any LEVADEX study, MAP added.
(USD1 = EUR0.705)
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|Date:||Aug 3, 2011|
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