following a resubmission:
mannitol (Bronchitol®) is accepted for restricted use within NHS Scotland.
Indication under review: Treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
SMC restriction: As an add-on to best standard of care in adult patients with CF who are not currently using dornase alfa due to lack of response, intolerance or ineligibility and have rapidly declining lung function and in whom other osmotic agents are considered unsuitable.
In two phase III clinical studies in patients with CF, inhaled mannitol was superior to a control treatment (a sub-therapeutic dose of inhaled mannitol) measured by absolute change in forced expiratory volume in one second (FEV1) over 26 weeks.
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Medicine details
- Medicine name:
- mannitol (Bronchitol)
- SMC ID:
- 837/13
- Indication:
- Treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
- Pharmaceutical company
- Pharmaxis Pharmaceuticals Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Resubmission
- Status
- Restricted
- Date advice published
- 09 December 2013