GlaxoSmithKline expects to make nonprescription Imigran Recovery (sumatriptan 50 mg) available in the UK in mid-June following approval for pharmacy sale by the Medicines & Healthcare products Regulatory Agency.

Sumatriptan, which is marketed Rx as Imitrex in the U.S., currently is sold by prescription in the UK as Imigran in 50 mg and 100 mg doses. Reclassification of the drug from Prescription Only Medicine (POM) to Pharmacy (P) was approved by MHRA May 19.

The product specifically was approved "to treat migraine attacks in patients with a stable and well-established pattern of symptoms."

Imigran Recovery will be sold to adults 18 and older through pharmacists in a two-count package designed to treat two migraine attacks, GlaxoSmithKline UK said.

"This move represents the first 'triptan' that can be given without a prescription in the UK and highlights the government's commitment to expand the range of medicines available for self-medication," MHRA stated in a release.

"Being able to purchase this medicine in a pharmacy will enable patients to take control of their own healthcare by accessing treatment straight away without having to spend time visiting their doctor."

A print advertising campaign will accompany the launch of the drug, GSK said. The ads will promote the message that Imigran Recovery can take migraine sufferers "out of the darkness and into the light," in reference to the tradition of migraine sufferers sitting in a darkened room to relieve symptoms.

With pharmacy sales of Imigran Recovery scheduled to take place under "carefully controlled conditions," pharmacists will be required to follow a "pharmacy protocol" designed to help them identify which patients are suitable for triptan treatment.

As a result, GSK intends to support the drug's launch with an educational program designed specifically for pharmacists, the spokesperson added.

Training methods and a patient questionnaire will be employed to help pharmacists provide the drug, MHRA noted. The methods "mimic what a general practitioner would go through with an Imigran patient," according to GSK.

In addition, "pharmacists will have clear guidelines to follow when supplying a triptan," according to the agency.

For example, they will be instructed not to supply sumatriptan to individuals who suffer from certain conditions such as high blood pressure, epilepsy, coronary heart disease, liver or kidney disease, or an allergy to sulphonamides.

Imigran will continue to be sold by prescription in 50 mg and 100 mg doses, MHRA added.

MHRA announced its interest in making sumatriptan available through pharmacists during a public consultation in August 2005. The consultation document also sought feedback from stakeholders on the possible reclassification of zolmitriptan 2.5 mg disintegrating tablet (AstraZeneca's Zomig ) (¹ Also see "UK Triptan Switch Considered As MHRA Seeks Comment On Imitrex, Zomig" - Pink Sheet, 15 August, 2005., p. 10).

The reclassification marks the first switch of a triptan in the UK, and the second switch worldwide of a triptan for GSK.

Germany's Ministry of Health approved the firm's Amerge (naratriptan) for nonprescription sale in late 2005 following the recommendation of an expert committee (² Also see "European Switches: Germany Looks To Triptans, McNeil Follows Zocor" - Pink Sheet, 4 July, 2005., p. 11). Amerge also is being marketed in two-count packages.

Triptans have been viewed by some in the U.S. as potential Rx-to-OTC switch candidates. The drug category also has created competition for OTC analgesics, particularly because headache is one of the leading ailments for which consumers seek relief from a nonprescription drug.

In 2004, a study by Pfizer compared the efficacy of its prescription Relpax (eletriptan) with Bristol-Myers Squibb's Excedrin Migraine .The study found that 65% of participants preferred the Rx treatment, citing "greater efficacy" and a "similar adverse event profile" (³ Also see "Pfizer Touts Relpax Efficacy Versus Excedrin Migraine In Study" - Pink Sheet, 22 March, 2004., p. 11).

- Melina Vissat

GSK’s Imigran Recovery Is First Triptan Approved For Nonprescription UK Sale

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