AcuCort Seeks Ethical Review for Allergy Treatment Questionnaire Study

AcuCort AB (post) (Stock market: ACUC) announces today that the company has submitted an application for ethics review to the Swedish Ethics Review Authority concerning a questionnaire study. The aim of the study is to document how allergic patients enjoy their treatment. The questionnaire study is an important part of the future pricing and reimbursement application at the Swedish Dental and Pharmaceutical Benefits AgencyTLV.

ISICORT® is a thin, small, fast-dissolving oral film that is placed on the tongue where the active anti-inflammatory substance, dexamethasone, dissolves quickly and provides effective relief. ISICORT® is approved in Sweden for the treatment of acute and severe allergic reactions, croup in children, chemotherapy-induced nausea and vomiting (CINV) as well as COVID-19 patients who require supplemental oxygen therapy. Intensive work is underway with registration applications for other priority markets.

The planned questionnaire study is an important element in AcuCort’s underwriting and reimbursement application with the Swedish underwriting and reimbursement agency, TLV. The study includes around 100 patients who will answer questions about their allergies and the value they place on other available treatment options.

“A subsidized price of ISICORT® is important for the patient as well as for AcuCorte before the next market introduction in Sweden. A positive result of the application for the Swedish Dental and Pharmaceutical Benefits AgencyTLV is also a strength in our exchanges with potential licensees and distributors, both in Sweden and in other priority markets. We hope for a positive decision from the Swedish Ethics Review Authorityand we look forward to having our application ready for submission to TLV in the second half of 2022,” says Jonas Jönmark, CEO of AcuCorte.

The information has been submitted for publication, through the contact person below, the April 26, 2022.

For more information please contact:
Jonas Jonmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
Email: [email protected]

On AcuCort AB (publication)
AcuCorte has developed and markets ISICORT®, a new, fast-dissolving oral film to be applied to the tongue, based on a well-known cortisone-based substance – dexamethasone. ISICORT® is a smart product in a new, innovative, patented and user-friendly dosage form, primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy-induced nausea and vomiting (CINV). A national request has been approved by the Swedish Medical Products Agency (MPA) in October 2020. In February 2021, ISICORT® has been granted an additional indication – the treatment of COVID-19 patients who require supplemental oxygen therapy. Overall, this reinforces the Company’s assessment that ISICORT®’s time to market could be relatively short. AcuCorte (ticker: ACUC) is listed on the Stock market in Sweden. Please visit www.acucort.com.

https://news.cision.com/acucort-ab/r/acucort-applies-for-ethical-review-for-a-questionnaire-study-on-allergy-treatment,c3552767

https://mb.cision.com/Main/15601/3552767/1568724.pdf

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