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Leading U.S. gynecologists see significant medical need for Pharmanest’s drug candidate SHACT

March 18, 2016
In December 2015, Pharmanest gathered leading U.S. gynecologists in Dallas, Texas, to discuss how its drug candidate SHACT should be used to best meet women's needs for pain relief during gynecological procedures. The meeting emphasized that the need for pain relief is enormous - patients' first question to the treating physician is usually: "Will it hurt?". After a careful review of the available documentation, the experts concluded that SHACT has good prospects to easily and safely reduce patients' pain perception.

“More and more U.S. women are selecting intrauterine devices as their method of birth control because of their high level of efficacy and convenience. IUDs are usually placed during a short procedure in a doctor’s office, but women may worry about any pain and discomfort they might feel during the procedure. The delegates at the expert meeting are all excited that a product like SHACT could help women more comfortably get these effective contraceptives. SHACT also has a potential to reduce pain within a wide range of gynecologic procedures”, says Anita L. Nelson, M.D., Professor of Obstetrics and Gynecology, Los Angeles, one of the specialist physicians attending the meeting.

The positive assessment of the expert group is based on extensive preclinical and clinical documentation, including a controlled clinical trial showing that SHACT provides fast pain relief during intrauterine device placements.
Gunvor Ekman-Ordeberg, Professor of Obstetrics and Gynecology at the Karolinska Institute and Board Director of Pharmanest summarizes the meeting: "A clinical study of 200 patients shows that SHACT in a significant way reduces pain and discomfort associated with IUD placement. These positive results have attracted great interest from leading gynecologists around the world, most recently at the meeting with the U.S. expert group in Dallas."

Preparation of the commercialization of SHACT in Europe is already in a final stage, while decisions and planning of a Phase III trial for registration in the U.S. will take place in the near future. SHACT is patent protected until at least 2031 in most parts of the world. To the company's kn owledge, there are currently no similar commercially available products for topical pain relief with documented efficacy.
"Women’s need of pain relief was distinctly confirmed by this group of leading U.S. gynecologists. Pharmanest will now do its utmost to make SHACT available for all those women who are exposed to pain during gynecological procedures. The support of our distinguished advisory board will be of great importance in this important task", says Gunilla Lundmark, CEO, Pharmanest.

Gunilla Lundmark, CEO, Pharmanest AB Phone: +46 709-74 90 57
Pharmanest AB is Swedish a privately-held company focused on new products for pain relief in the gynecology and obstetrics field. Pharmanest is specialized in the development of new topical analgesic formulations to be used on the mucosa. Pharmanest’s lead product, SHACT, is a unique proprietary short-acting formulation of lidocaine for pain relief with the lead indication treatment of pain during intrauterine device (“IUD”) placement. The clinical data generated so far clearly demonstrates that SHACT may play an important role in pain management within the gynecological procedure segment.

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