Global Insight Perspective | |
Significance | Imigran Recovery has become the first triptan available over the counter (OTC) - without a prescription - in the U.K., as a result of the MHRA’s action, in which patient safety was regarded as paramount. |
Implications | The move underscores a growing tendency towards self-medication, encouraged by the U.K. as a way of widening patient choice. For GSK, the switch crucially allows an extension of revenue generated by Imigran, which has just lost patent protection in the country. |
Outlook | However, the action, which follows the approval of the world’s first OTC statin , most importantly helps to slash the country’s growing healthcare bill. GSK hopes the OTC version will help to offset prescription-Imigran patent-protection loss in other European countries. |
First OTC Migraine Pill
The U.K. regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), revealed last Friday (19May) that patients will be able to obtain Imigran Recovery (sumatriptan) for the acute relief of migraine attacks in pharmacies, over the counter (OTC) without prescription.
Imigran Recovery, which is manufactured by U.K.’s GlaxoSmithKline (GSK) and contains 50 mg of the active ingredient sumatriptan, is to be sold from mid-June at the cost of £7.99 (US$15) for a pack of two tablets.
The availability of Imigran Recovery ‘under carefully controlled conditions’ will allow migraine sufferers to take control of their own health by obtaining ‘treatment straight away’, according to Kent Woods, Chief Executive of the MHRA.
GSK’s drug will be particularly valuable to patients who have ‘infrequent attacks’ and those who do not ‘always have prescription medicines to hand’ because triptans, the class of drugs to which Imigran belongs, should be taken at the earliest opportunity during a migraine attack, Woods added.
Nonetheless, pharmacists will have to adhere to strict protocol when selling the OTC drug, in order to ensure it is effective and safe for a particular patient. In fact, patient safety is paramount when considering any switch from a prescription drug to OTC use, according to Gordon Duff, chairman of the Commission on Human Medicines (CHM). He added that the safety profile of prescription Imigran, which has been marketed in the country during the last 15 years, is well established.
Outlook and Implications
The U.K. watchdog’s move follows a public consultation exercise, which commenced in August 2005, and comes as relief to the approximate 15% of the population reportedly suffering from migraine attacks. Imigran recovery will become the first marketed OTC drug whose mechanism of action targets the specific cause of a migraine attack, rather than just easing the symptoms. Currently, some 60% of migraine sufferers in the U.K. reportedly rely on OTC medication to ease their symptoms.
The green-light also underscores the U.K. Department of Health’s pledge to expand the repertoire of non-prescription drugs available, while further boosting the country’s position as the leader in switching prescription drugs to OTC. In fact, the U.K. recently became the first country in the world to approve the sale of an OTC cholesterol-lowering drug, a low-dose version of U.S. pharmaceutical giant Merck’s Zocor (simvastin).
For GSK, this switch extends the revenue generated by the Imigran franchise in the country, where it has just lost patent protection. The drug is also shortly due to become exposed to generic competition in many other European countries. However, the drug’s intellectual property (IP) protection still remains intact in the United States. Imigran generated global sales of £697 million last year, with the U.S. accounting for about 72%.
In general, consolidation appears to dominate the OTC drugs sector, whose future growth is expected to be largely driven by the growing tendency towards self-medication. In fact, GSK and U.K. firm Reckitt Beckinser are among the European firms thought be interested in bidding for U.S. Big-Pharma player Pfizer’s US$ 13-14 billion OTC drugs unit, sources familiar to the deal told Reuters. Earlier this year, Reckitt successfully secured BHI, health and beauty retailer Boots' (U.K.) OTC unit.