Conrad is a non-profit scientific organisation, based in Arlington, Virginia, that focused on reproductive health. It recently announced that the US Food and Drug Administration (FDA) grated ‘fast track’ approval to its tenofovir-based HIV microbicide. This clearance will put a rush on the development and review of the vaginal gel, which has shown positive results in preventing HIV transmission.
Researchers reported that a vaginal gel with 1% tenofovir—a drug that is already approved as oral medication to treat HIV-positive patients—was able to reduce male-to-female HIV transmission by 39%, and herpes by 51%. The results have created a great deal of hope for the potentials of the gel, and have given new vigour to a field that has recently suffered several successive failures.
Researchers emphasise the need for further trials in order to confirm the gel’s efficiency. However, the question on everyone’s mind is how fast the gel could become available. In order to somewhat assuage the anxious excitement, Conrad has met with FDA officials and other stakeholders to map out the course for the ultimate approval of the gel.
The FDA announced during the meeting that the ongoing trial would be sufficient for the non-profit to file a new application for FDA approval. It also stated that the company could speed up its data submission process as long as additional studies were conducted to chart efficiency and safety in adolescent and post-menopausal users.
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