Pharmanest meets all efficacy and safety end points in Phase II study of SHACT

barbara.lempert

STOCKHOLM – August 1, 2013. AB announced today positive results from a II- investigating the and tolerability of . The data show that is effective in reducing pain in connection with intrauterine device insertion. Karolinska Development owns 63% of Pharmanest*.
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 available to these women. 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:
”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.”
The Phase II-study with SHACT was a randomized, double-blind trial involving 218 women between 18 and 45 years of age. Data from the study shows that women that received 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. This effect was statistically significant (p < 0.0001). Patients who received SHACT also experienced less discomfort (p < 0.05) than women who received placebo. 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.
Torbjörn Bjerke, CEO of Karolinska Development :
“Pharmanest has made an extraordinary…Read more

Pharmalive – The Pulse of the Pharmaceutical Industry

Share This Post

Related Articles

Leave a Reply

© 2019 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS