Thursday, September 10, 2009

Obesity Combo-Drug Qnexa Reports Remarkable Phase III Results

VIVUS Inc., a California-based biopharmaceutical company, yesterday announced remarkably positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM) in more than 3,750 patients across 93 sites.

As I have blogged before, Qnexa is a propriety investigational drug combination of two older compounds, phentermine and topiramate that was investigated in three strengths: 15/92 (full dose), 7.5/46 (mid dose) and 3.75/23 (low dose).

The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.

The highlights of the studies, taken from the Vivus press release are as follows:

– Average weight loss of 14.7% (37 lbs) was achieved by patients treated with Qnexa for 56 weeks in the EQUIP study;

– Significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;

– Completion rates up to 69% were significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability;

No unexpected adverse effects were reported – the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia.

Depression scores, quality of life including self esteem and general health significantly improved for patients on Qnexa.

Several points regarding these studies are notable:

1) The almost 15% weight loss is the highest seen in pharmacological obesity trials thus far and falls only a few %points short of the long-term outcome of bariatric surgery (usually in the 16-20% range).

2) The fact that more patients on drug completed the study than on placebo suggests good tolerability or reflects the fact that participants were happy enough with their weight loss to tolerate the adverse effects for the duration of the study.

3) Given these results, it appears highly likely that Qnexa will meet the approval of regulatory agencies (currently Qnexa is not available to patients outside of clinical trials).

Not surprisingly, following the announcement, Vivus stock jumped 65% at the NASDAQ.

For a full copy of the Vivus press release click here

As I have blogged before – given our current limitations in the non-pharmacological management of obesity, any effective and safe addition to our pharmacological tool-kit is welcome.

AMS
Edmonton, Alberta

Disclaimer: I have no relationship to Vivus and (unfortunately?) own no shares of this company.

VN:F [1.9.22_1171]
Rating: 0.0/10 (0 votes cast)
VN:F [1.9.22_1171]
Rating: 0 (from 0 votes)

One Response to “Obesity Combo-Drug Qnexa Reports Remarkable Phase III Results”

  1. Nana Gletsu Miller says:

    Thanks for the information and for your summary. It is good to know that some good pharma prospects are on the horizon.

    nana

Leave a Comment

In The News

Diabetics in most need of bariatric surgery, university study finds

Oct. 18, 2013 – Ottawa Citizen: "Encouraging more men to consider bariatric surgery is also important, since it's the best treatment and can stop diabetic patients from needing insulin, said Dr. Arya Sharma, chair in obesity research and management at the University of Alberta." Read article

» More news articles...

Publications

  • Subscribe via Email

    Enter your email address:

    Delivered by FeedBurner




  • Arya Mitra Sharma
  • Disclaimer

    Postings on this blog represent the personal views of Dr. Arya M. Sharma. They are not representative of or endorsed by Alberta Health Services or the Weight Wise Program.
  • Archives

     

  • RSS Weighty Matters

  • Click for related posts

  • Disclaimer

    Medical information and privacy
    Any medical discussion on this page is intended to be of a general nature only. This page is not designed to give specific medical advice. If you have a medical problem you should consult your own physician for advice specific to your own situation.


  • Meta

  • Obesity Links

  • If you have benefitted from the information on this site, please take a minute to donate to its maintenance.

  • Home | News | KOL | Media | Publications | Trainees | About
    Copyright 2008–2014 Dr. Arya Sharma, All rights reserved.
    Blog Widget by LinkWithin