Karolinska Development AB (STO:KDEV):
Pharmanest AB today announced that the first patient has been dosed in
an open label pharmacokinetic study with its drug candidate SHACT, a
product developed for pain relief in connection with intrauterine device
(IUD) insertion. Karolinska Development AB owns 55% of Pharmanest.
Pharmanest's Phase I-study is an open study with the objective of
establishing 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. A randomized, double blind Phase
II study with about 200 patients is planned to start later this year.
"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. We see a great need for local pain relief
products in connection with IUD insertions and also in other
gynecological procedures", says Gunilla Lundmark, CEO of Pharmanest.
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.
The trial is expected to enroll 15 patients and the study will be
conducted at the Karolinska University Hospital, Solna, Sweden.
Principal investigator is Dr. Sara Törnblom Paulander, specialist in
obstetrics and gynecology.
"As the majority owner of Pharmanest, we are very pleased about the
initiation of this trial which marks an important step from preclinical
to clinical stage. I am excited about SHACT because it is a product that
addresses a clear medical need among millions of women around the
world", says Torbjörn Bjerke, CEO of Karolinska Development AB.
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