8 juni, 2022
AcuCort AB (publ) (Spotlight Stock Market: ACUC) announces today that the Swedish Ethical Review Authority has approved the company’s application for an ethical review regarding a questionnaire study on allergy treatment. 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.
In the development of AcuCort’s first market-approved drug SICORT®, a fast-soluble oral film containing the glucocorticoid dexamethasone, the company has managed to combine the benefits of the well-proven substance and the user-friendly mouth film for quick availability and relief in emergency situations.
The now approved questionnaire study is an important component in AcuCort’s pricing and reimbursement application to the Swedish pricing and reimbursement agency, TLV. The planned study includes about one hundred patients who will answer questions about their allergies and how they value the available treatment options. The other two components are partly a literature study and partly a panel of leading experts.
”It is gratifying that the Ethical Review Authority has approved our questionnaire study on allergy treatment, and we look forward to taking part in the results of the study. A subsidized price of ISICORT® is important for the patient, as the drug offers a completely new and unique form of administration; however, it is also important 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 an additional strength in our ongoing discussions with potential licensees and distributors. The goal is to submit our application to TLV during the second half of 2022,” says Jonas Jönmark, CEO of AcuCort.
ISICORT® is approved by the Swedish Medical Products Agency. Intensive work is underway with registration applications for other priority markets.
The information was submitted for publication, through the agency of the contact person below, on June 8, 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.