2 Apr, 12 | by BMJ Group
Selected items from the News and Latest Additions sections of www.palliativedrugs.com [link], the world’s leading palliative care website.
Crush resistant formulation of oxymorphone approved in US
The US Food and Drug Administration (FDA) have approved a crush resistant formulation of oxymorphone aimed at reducing abuse potential. The company (Endo Pharmaceuticals, Chadds Ford, Pennsylvannia, USA) plans to retain the name Opana® ER and replace the 7 dosage strengths of the current formulation of Opana® ER with the new crush resistant product during 2012.
FDA approve generic morphine sulphate m/r capsules
The US Food and Drug Administration (FDA) have approved a generic morphine sulphate m/r capsule (equivalent to Kadian®). Morphine sulfate ER (Watson Laboratories,Corona,California) is available as 20mg, 30mg, 50mg, 60mg, 80mg and 100mg extended release capsules.
Discontinuation of granisetron (Kytril®) infusion 1mg/mL
Roche has discontinued granisetron (Kytril®) infusion 1mg/mL (1mL and 3mL ampoules), with immediate effect in theUK due to low demand. A generic granisetron 1mg/mL solution for infusion or injection (1mL and 3mL ampoules) remains available from Hameln Pharmaceuticals.
Clonazepam oral solution – new licensed product
Rosemont Pharmaceuticals (0800 919312) has launched Clonazepam 0.5mg/5mL and 2mg/5mL oral solutions in theUK. They are licensed for all clinical forms of epileptic disease and seizures in adults. The formulations are not indicated for paediatric use due to the presence of ethanol and should not be mixed with water. The NHS cost of 150mL bottle of 0.5mg/5mL and 2mg/5mL is £40 and £48 respectively.
SMC accepts midazolam 5mg/mL oromucosal solution
The Scottish Medicines Consortium (SMC) has accepted midazolam 5mg/mL oromucosal solution (Buccolam®, Viropharma) for use within NHS Scotland for the treatment of prolonged, acute, convulsive seizures in children (3months to <18years). For more information click here.
FDA approve a fentanyl sublingual spray
The US Food and Drug Administration (FDA) have approved a novel fentanyl single-dose sublingual spray (Subsys®, Insys therapeutics, Phoenix, Arizona), indicated for treatment of breakthrough cancer pain in adult patients who are already receiving opioids for persistent cancer pain. The product is due to be launched shortly and will be available in individual, disposable spray units of 100microgram, 200microgram, 400microgram, 600microgram, and 800microgram strengths. This product will use the newly approved shared Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate Release Fentanyl (TIRF) products (see our news item 20-02-12). For more information click here.
Opioid-induced constipation in patients with advanced illness – What laxative do you use?
Prepared by Sarah Charlesworth and Andrew Wilcock