How has it been studied?
Cubicin infusions have been studied in two large studies involving 1,118 adults with complicated skin and soft tissue infections (mainly wound infections and major abscesses) and in one study involving 246 adults with bacteraemia caused by S. aureus, including 35 who also had right-sided infective endocarditis. In all three studies, Cubicin was compared with standard treatments for these infections (other antibiotics such as vancomycin or one of the penicillins, including oxacillin, cloxacillin, flucloxacillin and nafcillin). The studies looked at whether the infections had been cured or had improved.

Two further studies were carried out in a total of 40 healthy volunteers to show that Cubicin injections are as safe as the infusions, and that they produce similar levels of daptomycin in the blood.

What benefits has it shown during the studies?
Cubicin was as effective as the standard treatments.

In the studies of skin and soft tissue infections, the success rates at seven to 12 days after the last injection of Cubicin were 67% in one study and 85% in the other. The difference in response rates between the two studies was due to differences in the types of patients and infections being treated.

For the treatment of bacteraemia in patients with right-sided infective endocarditis, 42% of the patients receiving Cubicin (8 out of 19) and 44% of the patients receiving standard treatment (7 out of 16) were treated successfully. However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft-tissue infections.

What is the risk associated?
The most common side effects with Cubicin (seen in between 1 and 10 patients in 100) are infections caused by fungi (moulds and yeasts), urinary tract infections (infection of the structures that carry urine), Candida infection (a fungal infection), anaemia (low red blood cell counts), anxiety, insomnia

(difficulty sleeping), dizziness, headache, hypertension (high blood pressure), hypotension (low blood pressure), gastrointestinal and abdominal pain (stomach ache), nausea (feeling sick), vomiting, constipation, diarrhoea, flatulence (gas), bloating and distension (feeling as if the tummy is full), rash, pruritus (itching), pain in the limbs (arms or legs), infusion site reactions, pyrexia (fever), asthenia (weakness), abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage). For the full list of all side effects reported with Cubicin, see the package leaflet.

Cubicin should not be used in people who may be hypersensitive (allergic) to daptomycin or the other ingredient (sodium hydroxide). Caution is needed when it is given to patients with kidney problems and the medicine may need to be given less often. All patients must have their CPK levels measured at the beginning of their treatment and at regular intervals, particularly if they have any known risk factors for muscle damage. For the full list of precautions, see the package leaflet.

Why has it been approved?
The CHMP decided that Cubicin’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?
The company that makes Cubicin will carry out further stud