Second Time Lucky? Sumatriptan One Of Three Switches On The Cards In Germany
Executive Summary
A second attempt at switching sumatriptan for migraines, as well as switch applications for non-steroidal anti-inflammatories ketoprofen and liquid ibuprofen, are all on the agenda at Germany's next Expert Committee for Prescription meeting in June.
Germany’s Expert Committee for Prescription will consider three prescription-to-OTC switch applications at its next meeting on 27 June, including a second attempt at sumatriptan for migraines, as well as non-steroidal anti-inflammatories ketoprofen and liquid ibuprofen.
The first prescription-to-OTC switch on the table at the next committee meeting is migraine and cluster headache medicine sumatriptan (50mg for oral use).
This is not the first time this drug has been considered for switching by the committee. In 2012, the committee unanimously decided to recommend sumatriptan’s release from prescription status for migraines with and without aura in adults aged 18-65, after the initial diagnosis of migraine by a physician, as a 20mg nasal spray.
But the German Federal Council – which must approve the amendment to the country’s Drug Prescription Ordinance (AMVV), drafted by the Federal Ministry of Health (BMG) based on the committee’s recommendation – rejected the switch a year later for “formal reasons,” according to the German self-care industry association, the BAH.
New Zealand was the first country to switch sumatriptan in February 2006, beating the UK by just three months. Finland and Sweden then followed in 2008. All switches were for 50mg in up to two tablets per pack.
Ireland was the last country to switch sumatriptan (50mg), with Rowex Ltd taking up the challenge laid down by the country’s medicines agency, the HPRA, which had identified the drug as one of 12 ingredients it considered safe to be made available for self-selection in pharmacy. (Also see "Switchers, apply here, says HPRA" - HBW Insight, 23 Nov, 2018.)
Launched at the end of last year as Sumatran Relief, the OTC availability of the medicine – indicated for the acute treatment of migraine attacks with or without aura – was welcomed by the Irish Pharmacy Union. (Also see "Rowex launches OTC sumatriptan in Ireland" - HBW Insight, 23 Nov, 2018.)
June's Expert Committee for Prescription meeting will also consider the prescription-to-OTC re-classification of ketoprofen lysine salt for oral use. The US was the first country to switch the drug in 1995, with Bayer AG launching an OTC ketoprofen product under the Actron brand the same year. (Also see "Bayer's Actron OTC ketoprofen set to launch "within weeks"." - HBW Insight, 16 Oct, 1995.)
The Netherlands followed in 1996 (25mg tablets in packs of up to 16 units through drugstores and pharmacies and packs containing more than 16 units only through pharmacies), France in 1997 (25mg in packs of up to 500mg) and Australia in 2000 (25mg in packs of up to 30 dosage units).
Columbia, Estonia, Finland, Italy, Poland and South Korea all also offer OTC ketoprofen products.
The final prescription-to-OTC re-classification to be considered at the upcoming meeting will be ibuprofen for oral use in liquid preparations for adults and children over three months.
The timing of these applications is somewhat unfortunate, with France advising both adults and children to severely limit their use of ibuprofen and ketoprofen, particularly when suffering from a cough, cold, otitis, chickenpox, skin lesions or pulmonary infections, and to treat pain and/or fever with paracetamol.
ANSM’s advice is based on a review of adverse events related to ibuprofen and ketoprofen use by patients suffering from a range of mild infections which developed into more serious infections. (Also see "France Warns Of Serious Complications Related To OTC Ibuprofen Use" - HBW Insight, 25 Apr, 2019.)
Meanwhile, the committee will also consider reverse-switching first-generation antihistamines with sedative effect for patients over the age of 65.