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Beskrivning
| Land | Sverige |
|---|---|
| Lista | Spotlight |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
This is an English version of the press release published in Swedish on October 15, at 15:59 (SE time). AcuCort AB (Spotlight Stock Market: ACUC) reports that the results from the last of the two planned bioequivalence studies for registration of the company's drug candidate ISICORT® in the US did not meet the requirements for bioequivalence with the reference product. In the current study ISICORT® met the criteria for bioequivalence concerning two of the three criteria. AcuCort has previously reported positive results from the first of the two studies for registration in the US, and from the bioequivalence study on which the company's submitted application for market approval in Sweden is based.
The current study is performed on non-fasting participants, comparing ISICORT® 6 mg fast-dissolving oral film with an already approved reference product, West-Ward Pharmaceuticals' Dexamethasone 6mg tablets USP. The criteria for bioequivalence mean that the tested product should be within a certain range of the reference product's value for three criteria.
"We will now analyze the results in order to identify the measures needed to meet the US criteria for bioequivalence in the case of non-fasting participants. We continue working towards the unchanged goal to register and commercialize ISICORT®," says Mats Lindfors, CEO of AcuCort.
Mats Lindfors, CEO, AcuCort AB
Phone: +46 70 790 58 15
E-mail: