GSK’s Imigran Recovery Is First Triptan Approved For Nonprescription UK Sale
This article was originally published in The Tan Sheet
Executive Summary
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
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Triptans and ischemia
Triptan overuse does not increase the risk for ischemic attacks, but overuse of ergotamine may increase this risk, particularly in patients taking cardiovascular drugs simultaneously, according to the results of a retrospective case-controlled study published in the Oct. 10 issue of Neurology. E. Wammes-van der Heijden, et al., Utrecht University, The Netherlands, identified 188 cases of hospitalization related to ischemia and 689 controls were assigned the same index date as the cases. Researchers defined overuse of migraine medications triptans or ergotamine as 90 or more defined daily doses during a year. Triptan overuse was not associated with increased risk for ischemic complication (odds ratio of 0.96), but ergotamine overuse was related to higher risk of ischemia (odds ratio of 2.55). GlaxoSmithKline received nonprescription approval for Imigran Recovery (sumatriptan 50 mg) from the UK's Medicines & Healthcare products Regulatory Agency in May, which may open the possibility for a future U.S. triptan switch (1"The Tan Sheet" May 22, 2006, p. 3). Additionally, a generic Imitrex is slated for launch in 2008 (2"The Tan Sheet" Oct. 16, 2006, In Brief)...
Generic Imitrex
Dr. Reddy's will launch an "authorized" generic version of GlaxoSmithKline's migraine treatment Imitrex (sumatriptan) in the fourth quarter of 2008, according to a patent-infringement settlement agreement announced by the companies Oct. 10. Settlement of the patent litigation allows for earlier entry of a generic version of Imitrex; the suit related to GSK's patent no. 5,037,845, which has pediatric exclusivity extending through February 2009. The agreement also allows India-based Dr. Reddy's to exclusively distribute generic Imitrex in the 25, 50 and 100 mg strengths. GSK filed the patent infringement suit against Dr. Reddy's in December 2003 after the company submitted an ANDA seeking approval of sumatriptan. A 50-mg dose of sumatriptan (marketed by GSK as Imigran Recovery) was approved for nonprescription "Pharmacy" sale by the UK's Medicines & Healthcare products Regulatory Agency in May (1"The Tan Sheet" May 22, 2006, p. 3). GSK is also working with its partner Pozen toward a mid-2007 launch of a next-generation Rx migraine medicine Trexima, combining sumatriptan with naproxen...