Weight loss pill Qnexa wins panel vote and awaits approval

We know that, The combination of the drugs phentermine (see structure-1) and topiramate (structure -2) (trade name Qnexa) is an investigational medication for the treatment ofobesity and related conditions such as type 2 diabetes and has been found to lower blood pressure and cholesterol.  Qnexa is being developed by Vivus, a California pharmaceutical company.  Phentermine is an appetite suppressant and stimulant of the amphetamine andphenethylamine class. Topiramate is an anticonvulsant that has weight loss side effects.

Structure 1

Structure-2

       

Weight loss pill Qnexa wins panel vote and awaits approval: The drug was rejected in a 10-6 vote the first time it came before a Food and Drug Administration (FDA) advisory panel, in 2010, due to safety concerns. However when the medication returned for another review in February, the advisory committee gave it near-unanimous approval (20-2). Because the FDA often follows the advisory panel's advice, Qnexa is likely to get FDA approval, probably by mid-April.

                                                                                                                       

FDA panel votes in favor of earlier rejected anti-obesity drug Qnexa

In continuation of my up date on Qnexa

FDA panel votes in favor of earlier rejected anti-obesity drug Qnexa: Qnexa took a step closer to approval on Wednesday, when outside advisers to the U.S. Food and Drug Administration voted 20-to-2 in favor of approval. The panel also recommended the company conduct a study to scrutinize even more closely any risk of heart problems. That study may be required after the drug is approved. Should the FDA ask for further data on heart risks before any approval, it would delay Qnexa's launch further.

Phentermine & Topiramate combination (Qnexa®) for obstructive sleep apnea (OSA)....

In continuation of my update on Qnexa® (combination of Phentermine & Topiramate), a drug by VIVUS, Inc., I found this info really interesting  to share with.

VIVUS, Inc on 7. January 201, announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication. The OSA- study announced  demonstrated statistically significant improvement in the apnea/hypopnea index ("AHI" - a measure of the severity of sleep apnea) in patients with OSA treated with Qnexa for 28 weeks.

OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Currently, there are no approved pharmacologic treatments for OSA and current treatment approaches are limited to devices or surgery, so if approved by the FDA, Qnexa®  not only reduce the weight  but also significantly improve sleep apnea.

Ref : http://ir.vivus.com/releasedetail.cfm?ReleaseID=434708

Combination of Phentermine & Topiramate for obesity treatment......

We know that Phentermine (see structure) is  an appetite suppressant of the  amphetamine and phenethylamine class. It is approved as an appetite suppressant to help reduce weight in obese patients. Its  usually used for short-term and in combination with exercise, diet and behavioral modification. Is typically prescribed for individuals, who are at increased medical risk because of their weight and works by helping to release certain chemicals in the brain that control appetite.  

Mode of action : Phentermine, in doses clinically used, works on the hypothalamus portion of the brain to release norepinephrine, a neurotransmitter or chemical messenger that signals a fight-or-flight response, reducing hunger. Phentermine works outside the brain as well to release epinephrine or adrenaline causing fat cells to break down stored fat, but the principal basis of efficacy is hunger-reduction. At high doses, phentermine releases serotonin and dopamine as well, but such doses are never used in clinical medicine.  

Topiramate (structure below), is a known anticonvulsant agent and  also  reported  for  the  treatment   of

SSRI-  induced weight gain in anxiety disorders. However a combination   of these two drugs (Phentermine & Topiramate) has been  tried by VIVUS, Inc. and has submitted New Drug Application (NDA)   to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa (Phentermine & Topiramate combination) - its 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.

The NDA submission follows the successful completion of the phase 3 program for Qnexa, including the recently announced results from the 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 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. Hope people with obesity, will breathe a sigh of relief in the near future....

Ref : http://ir.vivus.com/releasedetail.cfm?ReleaseID=433172