"At that time, FDA said the data looked good," she said in an interview. "We just needed more time to work out the postmarketing requirements."
Those will include:
• A cardiovascular outcomes trial to assess the cardiovascular risk associated with Contrave use.
• Two efficacy, safety, and clinical pharmacology studies in pediatric patients (one in patients 12-17 years old, and one in patients 7-11 years old).
• A juvenile animal toxicity study with a particular focus on growth and development as well as behavior, learning, and memory.
• A cardiac conduction study.
• Clinical trials to evaluate dosing in patients with hepatic or renal impairment.
• A clinical trial to evaluate the potential for interactions between the medication and other drugs.
Contrave contains an extended-release formulation of 8 mg naltrexone and 90 mg bupropion. It is to be administered in an in a 4-week upward titration schedule, with a single morning tablet during week 1; a single tablet at morning and evening during week 2; two tablets in the morning and one in the evening during week 3; and two tablets both morning and evening from week 4 and onward.
Dr. Garvey is a consultant for Daiichi Sankyo, LipoScience, Takeda, Vivus, Boehringer Ingelheim, Janssen, Eisai, and Novo Nordisk. He has received research funding from Merck, AstraZeneca, Weight Watchers, Eisai, and Sanofi.
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