Efficacy demonstrated in clinical studies

Clinical studies show that SHACT can significantly prevent pain and discomfort in women undergoing gynecological interventions without causing any serious side effects. As far as the company is aware, there are currently no similar products with documented efficacy on the market.

In a 218-patient Phase II trial, women treated with SHACT experienced significantly less pain during IUD placment compared to those treated with placebo (p<0.0001). SHACT has completed a pivotal study in the EU and a Phase III study is planned in the US, with regulatory filings anticipated in 2017 and 2018 in the EU and US, respectively.

SHACT is patent protected until at least 2031

Pharmanest´s development product– SHACT – is patent protected at least until 2031. Several patents have been granted in the US, both for the planned commercial formulation as well as for several medical conditions. A patent has also been granted in China. In Europe a notice of allowance has been issued wheras the application in Japan is pending. Pharmanest has also been granted design protection for its unique applicator in the US, EU, Brazil and China.

Next steps toward the market

Pharmanest is currently  preparing for commercial production and completion of  the CMC work in order to 2017 submit an application for regulatory approval in the European Union. A US Phase III clinical trial (IUD placements) is being planned to further extend the product label for SHACT. This work is being conducted in collaboration with Advisory Board members in US, and with the FDA.
The company is considering out-licensing or selling the commercial  rights to SHACT to one or more major pharmaceutical companies prior to the market launch.