Migraine is a chronic condition with recurrent episodic attacks. It is rather unpredictable illness with its characteristics varying among patients. This unpredictability and variability is also observed within migraine attacks observed in a single patient. Among the most distinguishing features of a migraine is a potential disability caused by the accompanying headache and nausea with or without vomiting as well as extreme sensitivity to sound and light (Headache, 39: 720-727 (1999)). Because of the variability and complexity of the condition, effective management of patients suffering from migraines is challenging.
Migraine headaches which are considered “primary headaches” are about three times more common in women than in men. Geographically, the occurrence of migraine headaches varies significantly and ranges from 1.5% in Southeast Asia to 14% in Western countries (GRIM, Cephalalgia, 12:229 (1992); JAMA, 267:64-69 (1992) and Pharmacoeconomics, 11: 1-10 (Suppl.1)(1997)).
Systemic administration of anti-migraine and anti-nausea drugs orally to patients has not been very successful, in part because migraine is often accompanied by nausea and the orally administered drugs are vomited before they can take effect. The only viable route of administration for treatment of nausea and/or migraine is the intravenous or another injectable administration. These typically require a visit at the doctor's office or hospital. The failure to successfully treat migraine or nausea is thus based on a delivery method rather than on the drug effectiveness.
The vaginal delivery route of drugs through the vaginal mucosa to the uterus and/or to the general circulation has been discovered by inventors and is disclosed, for example, in the U.S. Pat. Nos. 6,086,909, 6,197,327 and 6,572,874 and in a co-pending application Ser. No. 10/600,849 and 10/349,029, all hereby incorporated by reference.
As well as the vaginal delivery route described in the above cited patents and application works, there is still some need for improvement, particularly as it concerns an efficacious quantitative drug delivery.
The current invention thus concerns an improved transmucosal delivery of anti-migraine and anti-nausea drugs through vaginal mucosa directly to uterus or to the general circulation which is more efficacious due to a more quantifiable sequestration of the drug within the impermeable layer or layers covering a proximal portion of the vaginal device.
It is therefore a primary objective of this invention to provide a vaginal device, such as a tampon, tampon-like foam or another vaginal device which is coated, or of which a proximal portion is coated, with a fluid impermeable layer(s) of film, foil, foam or xerogel forming a strip or an attached or removable cap or cup wherein said impermeable layer further comprises a mucoadhesive composition comprising an anti-migraine or anti-nausea drug, or a combination of both, said composition being released and delivered from said layer(s) substantially quantitatively through the vaginal mucosa into the uterus and/or to the general circulation.