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