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AcuCort’s first Phase IV study is now published

Results from AcuCort’s clinical Phase IV study with Zeqmelit® has been published in the scientific journal Journal of Market Access & Health Policy following peer review. The study reports positive results for Zeqmelit® oral film and provides valuable insight into how patients prescribed glucocorticoids for moderate to severe acute allergic reactions perceive their treatment, particularly in terms of accessibility, confidence and treatment effectiveness.

The published study, ZEQ001, included 50 patients, of whom 44 completed the study, and was conducted as an open-label, low-intervention Phase IV study in a real-world clinical setting. Over a six-month period, patients’ experiences with Zeqmelit® oral film were evaluated and compared with betamethasone tablets they had previously been prescribed for their allergic reactions. The study shows that patients not only value the oral film formulation but that it may also help ensure that treatment is more often available when it is actually needed.

“The study results are positive, and the publication of the findings in an international scientific journal is an important validation of their scientific relevance. The publication comes at a particularly timely point for AcuCort, as we are now entering a phase of international expansion,” says Jonas Jönmark, CEO of AcuCort.

 

The aim of AcuCort’s Phase IV study ZEQ001 was to collect scientific data from patients who had previously used tablets but were given the opportunity to use Zeqmelit® as part of the study. The study focused on patients’ experiences of the medicine’s effectiveness, their confidence in the treatment, and how convenient they found it to carry and use in everyday life.

 

Some of the results from the study shows that:

 

  • 98 per cent of patients reported being satisfied or very satisfied with the availability of Zeqmelit® oral film, compared with 58 per cent for tablets.
  • 77 per cent reported carrying Zeqmelit® with them more often than their corticosteroid tablets.
  • 78 per cent reported feeling more secure when having access to  Zeqmelit®.
  • In reported acute allergic reactions, Zeqmelit® was chosen in 16 out of 18 cases, and in 94 per cent of these cases, its effectiveness was rated as good or very good.
  • At the end of the study, a clear majority of patients preferred Zeqmelit® to tablets for future treatment.
  • 24 per cent of patients reported feeling more secure and being less likely to avoid specific situations when they had Zeqmelit® available.

 

The scientific article is entitled A Real-World Clinical Trial Evaluating Satisfaction and Experiences with a Dexamethasone Mouth Film Compared to Corticosteroid Tablets as Rescue Medication for Moderate to Severe Acute Allergic Reactions and has been published in Journal of Market Access & Health Policy.
 

The article is available via this link:
https://www.mdpi.com/2001-6689/14/3/43

 

For further information:
Jonas Jönmark, CEO, AcuCort AB
Phone: 070 365 5400
E-mail: jonas.jonmark@acucort.se

 

About AcuCort AB (publ)

AcuCort has developed and is commercializing Zeqmelit®, a new rapidly dissolving oral film placed on the tongue, based on the well-known cortisone substance dexamethasone. The drug is a smart product in a new, innovative, patented, and user-friendly administration form primarily for the treatment of severe and acute allergic reactions, croup in children, nausea and vomiting during chemotherapy, and for the treatment of patients with COVID-19 requiring supplemental oxygen therapy. Zeqmelit® is approved in Sweden, Denmark, Norway, and Finland, where the product is also marketed. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market. Visit www.acucort.se for more information.