Cardiome Pharma’s Xydalba treatment for ABSSSI available in UK
Canadian pharmaceutical company Cardiome Pharma’s new intravenous (IV) antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, known as Xydalba (dalbavancin hydrochloride), has been made available in the UK.
Xydalba is an IV antibiotic approved by the European Medicines Agency (EMA) and is currently the first and only option for ABSSSI.
ABSSSI are bacterial infections of skin and associated tissues mainly caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes, and can be potentially life-threatening.
The treatment offers a complete course of IV therapy delivered to the patient as a single 30-minute infusion.
It is reported to have successfully treated a majority of ABSSSI patients as outpatients, unlike the other IV antibiotics that might need to be administered for up to 14 days and can require hospitalisation.
The clinical development programme of Xydalba has shown that the therapy is as effective and well tolerated as other intravenous antibiotics, in addition to being effective against MSSA and MRSA bacteria.
IV antibiotic treatment for ABSSSI can be currently administered in the hospital through outpatient departments or outpatient parenteral antimicrobial therapy (OPAT) centres.
The treatment can be administered in one or two doses and allows the patients to be treated and discharged.
Cardiome medical affairs head Kiran Bhirangi said: “Xydalba represents a significant breakthrough in how ABSSSI are treated. It enables the patient to receive a course of effective treatment and go home.
“If the patient remains in the hospital for daily infusions, this not only uses the scarce resources of the National Health Service (NHS), but increases the risk of patients contracting further infections.
Classified as a ‘narrow spectrum’ antibiotic, Xydalba, as per government guidelines, is currently recommended to help prevent antibiotic resistance where appropriate.
The Xydalba ABSSSI DISCOVER studies involved two multicentre, randomised, double-blind, double-dummy, non-inferiority trials of similar design with an active comparator (vancomycin / linezolid).
During the trials, a total of 1,312 adult patients were involved in the studies and more than 25% were treated as outpatients.
Another randomised, double-blind phase III trial was conducted to assess the efficacy and safety of one-dose Xydalba versus the two-dose Xydalba regimen.
The study involved a total of 698 participants and 54% of them were treated as outpatients.