The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Budesonide / Formoterol (Symbicort® SMART) has been accepted for use as the regular treatment of asthma where use of a combination (inhaled corticosteroid and a long-acting β2 adrenoceptor agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and "as needed" short-acting β2 adrenoceptor agonists, or patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. This advice relates to the extension of the license for Symbicort maintenance and reliever therapy (SMART®) to adolescents aged 12 to < 18 years.
Buprenorphine oral lyophilisate (Espranor®) has been accepted for restricted as a substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. This advice is contingent upon the continuing availability of Patient Access Schemes (PAS). The license would also usually limit prescribing to specialist clinics.
Obeticholic acid (Ocaliva®) has been accepted for use in the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid. This advice is contingent upon the continuing availability of Patient Access Schemes (PAS).
Safinamide (Xadago®) has been rejected for the treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of Levodopa alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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