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Each year, an estimated 300,000 adults in the United States die of causes related to obesity [2] According to the guidelines of the National Institute of Health (NIH) regarding the treatment of obesity, weight loss drugs approved by the FDA [US Food and Drug Administration] may only be used as part of a comprehensive weight loss program, including dietary therapy and physical activity, for patients with a BMI [body mass index] of 30 with no concomitant obesity-related risk factors or diseases, and for patients with a BMI of 27 with concomitant obesity-related risk factors or diseases[3].The risk factors and diseases considered important enough to warrant pharmacotherapy at a BMI of 27--29.9 are hypertension, dyslipidemia, coronary heart disease (CHD), type 2 diabetes, and sleep apnea [3]

In its Complete Response Letter (CRL), the FDA cited undisclosed product quality and master filing issues for the infusion device, which is proprietary to the device manufacturer, according to Supernus announcement

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Substrate specificity of nicotinamide methyltransferase isolated from porcine liver (in Eng)