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Vivus have outlined the progress of their impotence drug avanafil in a new financial report.
Clinical trials showed the drug to be effective, and it’s now being examined by experts from the Food and Drug Administration (FDA) in America, who may decide to grant approval.
In the report, it’s revealed that: “In the avanafil investigational drug development program, we completed the two remaining phase 3 studies: in diabetics with erectile dysfunction and the long-term open label safety study. Both studies met all primary efficacy endpoints. The NDA filing for avanafil is scheduled for Q2 2011.”
The NDA is an independent organisation, which assists drug companies with the often-lengthy process of getting drugs onto the market.
Leland Wilson, the Chief Executive Officer of Vivus, said: “Our goals for 2011 include the continued advancement towards approval of QNEXA in the US and the EU and filing the NDA for avanafil.”
Avanafil works in a similar fashion to existing impotence treatments, such as Viagra, Cialis or Levitra. However, avanafil may have an advantage over those medications in one respect; it seems to take less time to take effect. Trials suggest that avanafil may get to work in just 15 minutes, which is significantly faster than Cialis and Viagra (both of which take around one hour to work). Levitra can work in as little as 25 minutes.
In related news, a new treatment from Bayer, the manufacturers of Levitra, called Levitra Orodispersible, was approved by drug regulation authorities last year but is not yet available in the UK.