New obesity pill effective; safety issues under review

Article

The first potential new prescription weight-loss pill to reach the US market in more than a decade is effective and well tolerated, according to a manufacturer's new drug application, but potential safety issues have stalled its approval by the FDA.

The first potential new prescription weight-loss pill to reach the US market in more than a decade is effective and well tolerated, according to the manufacturer's new drug application (NDA), but potential safety issues have stalled its approval by FDA.

The investigational drug Qnexa (tesofensine) is a controlled-release, once-daily pill that combines low-dose, immediate-release phentermine with a controlled-release formulation of the antiseizure drug topiramate.

If it is approved, the drug would be recommended for obese patients (body mass index [BMI] ≥30kg/m2) or overweight patients (BMI ≥27 kg/m2) with weight-related comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). It is intended to be used as a component of a diet and exercise program for weight loss and maintenance.

Additional reported risks include kidney stones, hyperammonemia (with or without encephalopathy, oligohydrosis, and hyperthermia), and visual disturbances.

Vivus, the drug's manufacturer, has announced plans to work with the FDA's Endocrinologic and Metabolic Drug Advisory Committee to resolve safety and labeling concerns in anticipation of the agency's scheduled October 28 decision on whether to approve the product.

Vivus Inc. VI-0521 (Qnexa) Advisory Committee Briefing Document. NDA 022580. Endocrinologic and Metabolic Drugs Advisory Committee Meeting. July 15, 2010. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/UCM218821.pdf. Accessed August 19, 2010.

Recent Videos
Eran Bornstein, MD, highlights early signs of preeclampsia clinicians need to know | Image Credit: northwell.edu.
Eran Bornstein, MD explains the need for first trimester preeclampsia screening | Image Credit: northwell.edu.
Veerle Bergink, MD, PhD, highlights familial links of postpartum psychosis | Image Credit: profiles.mountsinai.org.
Ivie Odiase, MD
Susan Khalil, MD
Sharon Erdrich, PhD, discusses why oral health should be routine in health care | Image Credit: linkedIn.com.
Sharon Erdrich, PhD, highlights oral health's impact on chronic pain | Image Credit: linkedIn.com.
Fiona Gilbert, MA, MB, discusses breast cancer screening for dense breasts | Image Credit: newn.cam.ac.uk
Related Content
© 2025 MJH Life Sciences

All rights reserved.