Pharmanest, a Stockholm-based pharmaceutical company, has dosed its first patient has in an open label pharmacokinetic phase I study with its drug candidate SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion.
Pharmanest’s phase I trial’s objective is to establish the pharmacokinetic properties of SHACT when applied in the cervix and uterus of women receiving an IUD. Secondary objectives are to evaluate the safety and tolerability. The trial is expected to enroll 15 patients and the study will be conducted at the Karolinska University Hospital in Solna, Sweden.
"Every year, millions of women have IUDs inserted. Many women experience pain in connection with the insertion, and there are only few local pain relief products on the market with documented efficacy. Therefore, in most countries, patients have no choice other than oral painkillers or no pain relief at all,” said Gunilla Lundmark, CEO of Pharmanest. “We see a great need for local pain relief products in connection with IUD insertions and also in other gynecological procedures.”
SHACT is applied topically in the cervix and uterus using applicator developed by Pharmanest. The aim is to achieve immediate pain relief without the use of advanced equipment.
A randomized, double blind phase II study with about 200 patients is planned to start later this year.