Karolinska Development has reported that the Pharmanest Phase II study of SHACT, a proprietary four percent lidocaine formulation, met all efficacy and safety end points.
Developed by Pharmanest, SHACT is based on a formulation of anaesthetic lidocaine and a proprietary application device developed for simplification of topical application in the cervix and uterus.
According to the data, SHACT, which is thermogelling and becomes a gel at body temperature, demonstrated efficacy in reducing pain in connection with intrauterine device (IUD) insertion.
Pharmanest CEO Gunilla Lundmark said clinical evidence suggests that SHACT represents a major breakthrough for women that experience pain and discomfort during IUD insertion.
"Pain management in connection with IUD insertion represents a significant commercial opportunity alone, but as SHACT is specifically designed for topical administration we also see significant potential for other clinical uses," Lundmark added.
A total of 218 women between 18 and 45 years of age participated in the randomised, double-blind trial.
As per the study data, women receiving SHACT during IUD insertion experienced a more than 30% reduction in pain, measured on a visual analogue scale (VAS), compared to patients who received placebo, which was statistically significant.
SHACT-patient group experienced less discomfort (p < 0.05) than women who received placebo and reported similar adverse events, in terms of type and frequency, compared to placebo treatment.
Karolinska Development CEO and owner of 63% of Pharmanest Torbjörn Bjerke said: "With these positive data it is clear that SHACT has the potential to become the first safe and effective pain relief product for millions of women who use IUD."
Conducted in Sweden at the Karolinska University Hospital in Solna and two other sites, the study noted most common adverse events such as nausea in both treatment groups, while no serious adverse events were reported.