Ah, the world of small pharmaceutical stocks. Such a crapshoot it is. Somedays you win when you get great trial results. Other days the FDA is slapping a big warning label on your drug, and you’re getting sued to smithereens.
Today’s winner: Vivus Inc., which is up 75%, on a new fat pill.
If their claims are true, and there are really few side affects, and the FDA approves the drug, this sounds pretty good.
VIVUS, Inc. (VVUS) today announced 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), an investigational drug, in more than 3,750 patients across 93 sites. 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.
Highlights from the EQUIP and CONQUER studies include:
- 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;
- FDA efficacy benchmarks for weight loss agents exceeded at all three doses of Qnexa tested in the clinical program;
- Completion rates up to 69% were significantly higher than placebo at all three doses of Qnexa, indicating favourable tolerability; and
- favourable benefit/risk safety profile for Qnexa.
“The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA,” stated Leland Wilson, president and chief executive officer of VIVUS. “The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company’s plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand.”