Qnexa, an once-daily formulation to aid weight loss, is under regulatory review in US, Vivus, Inc annonced in a press release.
Vivus has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking approval of Qnexa.
Qnexa is an investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type-2 diabetes, dyslipidemia or central adiposity.
Once-a-day, proprietary, oral, controlled-release Qnexa is a formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety – the two main mechanisms that impact eating behavior – in one capsule.
Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors in phase 2 and 3 clinical studies.
The phase-3 programme for Qnexa included two pivotal, year-long phase-3 studies, Equip and Conquer.
In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current US FDA Guidance for Developing Products for Weight Management.
Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors.
“The weight loss seen in all of the phase-3 trials supports our belief that, if approved, Qnexa could be an effective treatment for patients who are obese or overweight with co-morbidities,” stated Leland F. Wilson, chief executive officer for Vivus.
The weight loss of up to 14.7 per cent (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries, he added.
The EQUIP and CONQUER studies were 56-week, randomized, double-blind, placebo-controlled, 3-arm, prospective trials with patients randomized to receive once-a-day treatment with low-, mid-, or full-dose Qnexa, or placebo.
In EQUIP, the average baseline BMI of the study population was 42.1 kg/m(2) with an average baseline weight of 256 pounds; in CONQUER, the average baseline BMI of the study population was 36.6 kg/m(2) with an average baseline weight of 227 pounds. All patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program.
Vivus is a biopharmaceutical company developing innovative, next-generation therapies to obesity, diabetes and sexual health.
In the area of sexual health, Vivus is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist for the treatment of hypoactive sexual desire disorder (HSDD) in women. Muse (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS.