Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2000-01-27
2001-11-20
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S451000, C424S464000, C424S466000, C424S474000, C424S490000, C514S225200, C514S568000, C514S557000
Reexamination Certificate
active
06319514
ABSTRACT:
BACKGROUND TO THE ART
The current means of combating migraine attacks include simple analgesics such as aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDS) and paracetamol, taken at the earliest signs of an attack [1,2,3]. Aspirin, paracetamol and phenacetin have long been among the most commonly used members of the NSAIDS class. Amongst the newer NSAIDS are ibuprofen, ketoprofen, mefenamic acid, diflunisal, naproxen and piroxicam. The most widely used NSAIDS available over the counter that have fewer gastro intestinal side effects than aspirin are paracetamol and ibuprofen.
Combined preparations of paracetamol or aspirin with an anti-emetic agent such as buclizine or metoclopramide, have been used to alleviate the nausea symptoms that often accompanied a migraine attack. Commercially, they are available as Migraleve Duo®, Paramax®, Migravess®. Narcotic analgesics such as codeine have also been employed together with NSAIDS to obtain synergistic analgesia, for example Migraleve Yellow®, co-codamol.
Gastric stasis, commonly present in migraine[4], causes the poor absorption of the analgesics. Dispersible and effervescent formulations have been used in an attempt to overcome this [4]. Metoclopramide, an anti-emetic, also relieves gastric stasis which has been found useful counteracting the reduced analgesic effects of paracetamol in migraine attacks [1,4,5].
Attacks who do not respond to analgesics may be treated with ergot preparations such as ergotamine tartrate. Newer alternatives to ergot compounds for acute migraine are the selective serotonin 5HT1 agonist, for example Sumatriptan® [6,7]. Recent trials reported that oral 100 mg sumatriptan to be as effective as aspirin 900 mg plus 10 mg metoclopramide for initial attacks and more effective in subsequent attacks [8].
The use of metoclopramide combined with either paracetamol, or aspirin has already been disclosed. Domperidone is a dopamine antagonist but is less likely than metoclopramide to produce extra pyramidal side effects since it does not cross the blood brain barrier. It stimulates gastro-intestinal mobility and is used in the management of nausea and vomiting. The activity of domperidone on the gastro intestinal mobility could enhance the rate of absorption of the analgesics. In Cephalagia 13 (2), 124-7 (1993), the safety and efficacy of separately administered domperidone in combination with paracetamol in the treatment of acute attack of migraine was demonstrated. The method of making a film coated tablet containing paracetamol and domperidone is disclosed in WO95/22974.
As far as the inventor knows, the art has never suggested that domperidone either be added to selected NSAIDS, which differ substantially in chemical structure from paracetamol; or be added to selected NSAIDS together with selected narcotic analgesic drugs. Also, the prior art does not suggest the use of any two-component composition of a selected NSAID and domperidone; and three-component of a selected NSAID, a selected narcotic analgesic and domperidone to hasten the analgesic response and to manage nausea symptoms in migraine attacks.
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Arent Fox Kintner & Plotkin & Kahn, PLLC
Berman Alysia
Dudash Diana
The Boots Company PLC
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