A Novel Mucosal Pain Relief Drug Candidate -SHACT – gives highly significant analgesia at Insertion of Intra Uterine Device (IUD)
ESC Congress Library. Ekman-Ordeberg G. May 28, 2014; 50555; A-140
Gunvor Ekman-Ordeberg
Gunvor Ekman-Ordeberg
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Abstract
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Objective: To evaluate the analgesic effect of a new formulation for topical application during insertion of Intra Uterine Device (IUD).



Methods: SHACT is a proprietary 4 % Lidocaine formulation developed by Pharmanest AB. It is applied topically at the portio, in the cervical canal and into the uterus with a proprietary device developed by Pharmanest AB. SHACT is thermogelling and becomes a gel at body temperature, which minimizes the leakage after application. In a first study in women (Phase I) the pharmacokinetic properties of SHACT were investigated. The study showed that the majority of women had measurable levels of Lidocaine after 5 minutes supporting a rapid onset of action. No toxicity concerns were observed during the study. A confirmatory efficacy and safety study with SHACT was a randomized, controlled, double-blind trial involving 218 nulliparous women between 18 and 45 years of age. All were planned for insertion of an IUD.




Results:


Data from the study shows that women receiving SHACT during IUD insertion experienced an analgesic effect with less pain, measured on a visual analogue scale (VAS), compared to patients who received placebo. This effect was statistically significant (p < 0.0001). Overall this study clearly demonstrates significant reduction in pain during insertion of an IUD. The effect size is of clinical importance since on average 3 out of 4 patients will experience an advantage of SHACT compared to placebo.



Conclusion:


SHACT has proven to be an effective analgesia, easy to apply and with fast onset of action at IUD insertion. Pharmanest AB can also see significant potential for other clinical use and plans to further explore other indications in clinical trials.

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