Today, Pharmanest AB announced that the first patient has been dosed in
a randomized Phase II study of SHACT, a product developed for pain
relief associated with intrauterine device (IUD) insertion. Karolinska
Development AB (STO:KDEV) owns 58.9 percent of Pharmanest.
All patients in the initial Phase I study with SHACT are included and
the first patient has now received a dose in a double-blind, randomized,
placebo-controlled Phase II study. The goal of the Phase II study is to
evaluate the effect of SHACT in connection with IUD insertion in women.
Secondary objectives include evaluating safety and tolerability.
Gunilla Lundmark, CEO of Pharmanest:
"The results from this study will be an important step closer to a
possible new local anesthetic product. Many women experience pain
associated with IUD insertion and there are few local anesthetic
products on the market with proven efficacy in this indication. We see a
great need for SHACT associated with IUD insertion as well as for other
gynecological procedures."
SHACT is applied topically in the cervix and uterus with devices
developed by Pharmanest. The goal is to achieve immediate pain relief
without the need for advanced equipment. The Phase II study is expected
to enroll approximately 200 patients and will be conducted at the
Karolinska University Hospital. Principal Investigator is Dr. Sara
Törnblom Paulander, a specialist in obstetrics and gynecology.
Torbjörn Bjerke, CEO of Karolinska Development and board member of
Pharmanest:
"We are very pleased that Pharmanest takes the next important step in
the development of SHACT. This is a product that addresses a clear
medical need among the millions of women worldwide inserting IUD each
year. "