Vivus, the biopharmaceutical company behind investigational drugs Qnexa and Avanafil, has just reported its financial results for the first nine months of 2010. Within those results there is a clear indication that the company has not in any way been floored by the recent decision by the FDA not to approve Qnexa, its investigational weight loss drug that contains low dose phentermine and topiramate, both of which are licensed separately in the US. Vivus says that it will answer the FDA’s questions within 6 weeks. It has already released the extended clinical data requested by the FDA that demonstrates the safety and efficacy of Qnexa over 108 weeks, with patients achieving and maintaining a weight loss of at least 10% of body weight over the period – far in excess of the 2.5% achieved by trial subjects on the placebo.
The FDA’s concerns relating to Qnexa surround the increased heart rate identified in some cases during the trial period. The main concern that needs to be addressed is that the increase in heart rate does not affect overall cardiovascular risk. The FDA is also concerned about potential birth defects caused by the Topiramate element, which has an established risk in this area, albeit at a much higher dose than in Qnexa. 13 women gave birth during the Qnexa clinical trials and none of the babies suffered birth defects. We would expect pregnancy to be included as a contraindication with this drug, just to be on the safe side. There is a possibility that Qnexa will be approved as a controlled drug and will therefore not be available online through legitimate channels.
Vivus has now indicated that it will be applying for a license for Qnexa in the EU before the end of 2010 – this is real news for most of our readers as it is the first time that it has been mentioned explicitly by the company.
Vivus has also stated that it is pushing to complete phase III trials of Avanafil, its investigational medication for the treatment of erectile dysfunction. Avanfil is very similar to established drugs in this area such as Viagra and Cialis but it has a much faster onset time. Patients taking Avanafil were able to achieve erections sufficient for penetration within 15 minutes of oral administration. Given that the medication is very similar to other licensed medications and no major new side effects have been reported, we would expect Avanafil to get a license.