California based pharmaceutical development company, Vivus, will have a busy month this January as they hope make progress with the FDA on their two leading drug candidates. Avanafil, a PDE5 inhibitor used in men suffering erectile dysfunction wows with 80% of men taking it achieving erections and two thirds able to have intercourse. In addition, it only takes 15 minutes for the drug to take effect unlike the other PDE5 inhibitors which can take up to an hour.
The approval of their promising weight loss drug, Qnexa, will also be discussed with US regulators this month. Recent trials have proved successful despite the FDA requiring more information. Vivus has submitted more detail on the associations between Qnexa and side effects such as birth defects and cardiovascular risk. Vivus is not a done deal yet but the company appears confident that they will get the green light in August without a pre-authorization cardiovascular risk study.
Long term trials for Avanafil have revealed great potential for the medication. The results released last week reveal that the treatment will work on a majority of its users and due to the speed with which it is metabolized it can be used twice a day without risk.