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NICE supports use of delafloxacin for hospitalised patients with severe skin infections

Hospital admissions for severe acute skin infections require prompt and effective treatment and NICE has endorsed the use of delafloxacin for treating such patients.

In an evidence review from NICE, it was concluded that the fluoroquinolone antibiotic, delafloxacin may be considered for the hospital treatment of adults with severe acute bacterial skin structure infections (ASSSI) including cellulitis or erysipelas, abscesses and wound infections. Such infections result in a significant number of hospital admissions each year. In fact, between 2017 to 2018 there were 80,000 emergency hospital admissions for cellulitis with more than 36,000 cases of skin abscesses, boils and carbuncles, leading to over 430,000 and 85,000 bed days respectively. Delafloxacin has the potential to treat infections caused by both gram-positive e.g., methicillin-resistant Staphylococcus aureus (MRSA) and gram-negative organisms without the need for combination treatment. Despite this potential advantage, a 2019, MHRA drug safety update suggested restrictions and precautions for fluoroquinolone drugs due to reports (albeit rate) of long-lasting or irreversible adverse effects on either the musculoskeletal or nervous system. However, in a European Public Assessment report for delafloxacin, some data indicated a possible safety benefit for the drug compared to other fluoroquinolones.

In the evidence summary, NICE drew upon data from two Phase III trials comparing delafloxacin mono-therapy against a combination of vancomycin and aztreonam, despite this latter combination not being a standard treatment option in the UK. The results showed that delafloxacin was non-inferior to the dual therapy at reducing lesion size by at least 20% after 48 to 72 hours in adults with cellulitis or erysipelas, wound infection, major cutaneous abscess or burn infection. In addition, in terms of investigator-assessed clinical cure after 14 days, both delafloxacin and vancomycin and aztreonam had similar outcomes. In both studies the most common pathogen was Staphylococcus aureus, including MRSA and by day 14, either documented or presumed eradication was similar for both delafloxacin mono-therapy and vancomycin plus aztreonam with similar treatment-related adverse effects.

Delafloxacin is available as a 300mg powder with a recommended dosage of 300mg every 12 hours, administered over 1 hour. An oral tablet containing 450mg (which is bio-equivalent to the 300mg IV) is licensed to be used every 12 hours for up to 14 days. While the evidence of non-inferiority for delafloxacin was promising, a limitation of the data was that studies only included patients of White ethnicity and those who were mostly under 65 years of age and therefore not reflective of the patients likely to have severe skin infections, e.g., patients with diabetes. Despite this, NICE still endorsed the use of delafloxacin.

The full NICE evidence review can be found here.