Orexigen^® Therapeutics, Inc. OREX, a biopharmaceutical company focused on the treatment of obesity, today
announced progress with the United States Food and Drug Administration (FDA)
on a faster path to resubmission of the Contrave^® (naltrexone SR / bupropion
SR) New Drug Application (NDA).
Consistent with the spirit of the formal dispute resolution request (FDRR)
response letter issued to the Company in October by the FDA's Center for Drug
Evaluation and Research, the Division of Metabolism and Endocrinology Products
(DMEP) has proposed a resubmission procedure that allows the independent Data
Monitoring Committee's summary report of the Light Study interim analysis to
form the basis of the resubmission of the Contrave NDA. The complete clinical
study report (CSR) for the interim analysis, which would ordinarily form the
basis for the NDA resubmission filing, would be supplied to the FDA during the
review within 60 days of the NDA resubmission.
The Data Monitoring Committee will conduct the interim analysis after at least
87 major adverse cardiovascular events (MACE) are adjudicated in the Light
Study. The timing of the interim analysis is dependent upon the rate of MACE
in the Light Study. Although the annual MACE rate is still too early to
predict, if it is close to the target of 1.5%, Orexigen anticipates conducting
the interim analysis and resubmitting the Contrave NDA in the second half of
2013 with potential approval in early 2014.
Orexigen also announced continued preparation for commercialization of
Contrave, if approved, with plans to initiate the Ignite Study, a randomized
open-label clinical trial designed to provide additional information regarding
the real world weight loss potential of Contrave therapy with a commercially
available comprehensive lifestyle intervention program versus usual care.
Orexigen plans to initiate randomization of approximately 200 patients into
the Ignite Study later this quarter.
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