26 april, 2022
AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces today that the company has submitted an ethical review application to the Swedish Ethical Review Authority regarding a questionnaire study. The purpose of the study is to document how allergy patients value their treatment. The questionnaire study is an important part of the future pricing and reimbursement application to the Swedish Dental and Pharmaceutical Benefits Agency, TLV.
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 need supplemental oxygen treatment. An intensive work is underway with registration applications for other priority markets.
The planned questionnaire study is an important component in AcuCort’s pricing and reimbursement application to the Swedish pricing and reimbursement agency, TLV. The study includes about one hundred patients who will answer questions about their allergies and how they value other available treatment options.
”A subsidized price of ISICORT® is important for the patient as well as for AcuCort before the upcoming market introduction in Sweden. A positive outcome of the application to the Swedish Dental and Pharmaceutical Benefits Agency, TLV, is also a strength in our discussions with potential licensees and distributors both in Sweden and in other priority markets. We hope for a positive decision by the Swedish Ethical Review Authority, and we look forward to having our application ready for submission to TLV during the second half of 2022,” says Jonas Jönmark, CEO of AcuCort.
The information was submitted for publication, through the agency of the contact person below, on April 26, 2022.
For more information, please contact:
Jonas Jönmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
About AcuCort AB (publ)
AcuCort has developed and commercializes ISICORT®, a new fast-dissolving oral film to put on the tongue, based on a well-known cortisone 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 application was approved by the Swedish Medical Products Agency (MPA) in October 2020. In February 2021, ISICORT® was granted an additional indication – the treatment of COVID-19 patients who need supplemental oxygen treatment. Altogether, this strengthens the company’s assessment that the time to commercialization of ISICORT® may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.com.