The Stockholm-based pharmaceutical company Pharmanest AB, a portfolio company of Karolinska Development, has announced positive results from a Phase II-study investigating the efficacy and tolerability of the pain-reducing product SHACT. Results show that the pharmaceutical developed by Pharmanest is effective in reducing pain in connection with intrauterine device insertion.
Pharmanest is yet another successful example of a research-based spin-off company from the Karolinska University Hospital and the innovation-driven environment of Karolinska Institutet. Since inception 2009, Pharmanest are successfully developing a set of new products for use during gynecological procedures based on well-known substances. The aim is to reduce pain experienced by women during gynecological procedures and child birth.
Solving an old problem Every year, millions of women around the world experience pain and discomfort during IUD insertion (intrauterine contraception). There are few treatment options with proven efficacy and safety available to these women. Therefore, Pharmanest has accepted the challenge in developing something entirely new to solve the problem and treat these women, something revolutionary but still based on previously known, tried and tested substances. SHACT is a product based on an innovative formulation of lidocaine, a well-known anesthetic, and a proprietary application device developed to simplify topical application in the cervix and uterus. Gunilla Lundmark, CEO of Pharmanest, underlines that so far, the 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”, she says.
A most successful study The Phase II-study using SHACT was a randomised, double-blind trial involving 218 women between 18 and 45 years of age. Data from the study shows that women who received SHACT during IUD insertion experienced a significant reduction in pain, measured on a visual analogue scale (VAS), compared to patients who received placebo. Patients who received SHACT also experienced less discomfort. Women who received SHACT reported similar adverse events, in terms of type and frequency, as women who received placebo treatment. The most common adverse event was nausea in both treatment groups. No serious adverse events were reported. “We have gone from first human dose to clinical proof of concept in just fifteen months. With these positive data it is most possible that SHACT will become the first safe and effective pain relief product for millions of women who use IUD”, Gunilla Lundmark continues.
Taking the next step The study, conducted in Sweden at the Karolinska University Hospital in Solna and two other sites, met all primary and secondary objectives and provides a clinical foundation for the regulatory submission of SHACT in the European Union (EU) as well as other countries around the world. “The study was a first proof of concept study and we now plan to evaluate other indications where we can see a growing potential. Interested companies have already been in touch and we will initiate a dialogue with these potential partners this fall”, Gunilla Lundmark reveals.