Methods for treatment of headaches by administration of oxytocin

Abstract

The present invention relates to methods for the treatment of headache and headache disorders. The methods comprise administration of an oxytocin peptide for the treatment of primary and secondary headaches or trigeminal neuralgia.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The application is related to and claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 711,950, filed Aug. 26, 2005 and U.S. Provisional Patent Application Ser. No. 60 / 794,004, filed Apr. 21, 2006, the entire contents of which are hereby incorporated by reference herein in their entirety.TECHNICAL FIELD [0002] The present invention relates generally to methods and compositions for the treatment of headache and headache or head pain disorders. More specifically, the present invention relates to methods for the treatment or prevention of primary or secondary headaches by administration of oxytocin. In particular, the present invention relates to methods for the treatment or prevention of migraine, cluster, tension headaches or trigeminal neuralgia by administration of oxytocin or pharmaceutical compositions comprising oxytocin to individuals in need of treatment. BACKGROUND OF THE INVENTION [0003] Although the epidemiolog...

AI Technical Summary

Benefits of technology

[0024] Provided herein are methods for treatment and / or prevention of headache pain or trigeminal neuralgia in an individual comprising administering to the individual i) an effective amount of a pharmaceutical composition comprising an oxytocin peptide and ii) a vasoconstrictor. Generally, administration of the vasoconstrictor reduces systemic distribution of the oxytocin peptide. In some examples the vasoconstrictor is selected from the group comprising phenylephrine hydrochloride, tetrahydrozoline hydrochloride, naphazoline nitrate, oxymetazoline hydrochloride, tramazoline hydrochloride, ergotamine, dihydroergotamine, endothelin-1, endothelin-2, epinephrine, norepinephrine and angiotensin. In some examples the vasoconstrictor is administered prior to the administration of the pharmaceutical composition. In other examples the vasoconstrictor is co-administered with the pharmaceutical composition. In some examples administration of the vasoconstrictor results in a decreased effective dosage requirement of the oxytocin peptide. In other examples the pharmaceutical composition further comprises at least one additional analgesic agent.

Problems solved by technology

Not only are headaches painful, but headache disorders can be disabling to afflicted individuals.

Headache disorders may impose substantial hardships and burdens on the afflicted individuals including personal suffering, impaired quality of life and high financial cost.

Repeated headache attacks, and often the constant fear of the next one, can damage an individual's family life, social life and their productivity at their place of employment.

Finally, the long-term effort of coping with a chronic headache disorder may also predispose an individual to other illnesses.

Physical exertion often makes a migraine headache worse and women are more likely than men to have migraine headaches.

Although the syndrome is well defined from a clinical point of view, the causes are not well understood.

Pain is generally extremely intense and severe and often described as a burning, boring, stabbing or piercing sensation.

In contrast to migraine headaches, cluster headaches occur more in men than women and individuals suffering from these attacks may be very restless.

For example, tension headache may be caused by the tightening of facial and neck muscles, clenching or grinding of teeth and / or poor posture.

Trigeminal neuralgia, also called “tic duloreaux” is a condition that affects the trigeminal nerves and results in severe facial and head pain.

However, to date, there is no single treatment strategy (including prevention or prophylaxis) that successfully alleviates migraine in a majority of patients.

Additionally, treatment that has proven effective in one particular migraine sufferer may only be partially or intermittently effective.

Despite being effective, serotonin receptor agonists often only partially attenuate migraine headache.

Furthermore, side effects may arise including dizziness, heaviness or pressure on the chest and arms, shortness of breath, and sometimes chest pain which limit their clinical utility.

Ergotamines, although commonly prescribed, are less effective than triptans and NSAIDS.

Opioids such as codeine and butorphanol are not a first choice for the treatment of migraine because of their limited effectiveness, associated side effects including sedation and respiratory depression and the potential for dependence and abuse.

Preventive treatment strategies are considered whenever migraine attacks have occurred several times in a month or are very severe and do not respond well to abortive medication.

In a significant number of patients abortive and preventive treatments for migraine headache are often either ineffective, only partially effective or associated with significant side effects including hypotension, tiredness, increased weight, breathlessness, dizziness, heaviness or pressure on the chest and arms, shortness of breath, chest pain, nausea, muscle cramps, or peripheral vasoconstriction.

However, all these treatment strategies require a visit to a doctor's office or to an emergency room.

Unlike drugs that ablate cluster headache (abortive drugs), most of the drugs used to prevent cluster headache have been developed for other clinical conditions and unfortunately, their effectiveness in prevention is limited.

However these drugs have significant side effects including sedation, weight gain, dry mouth and constipation.

However, a significant portion of patients (>50%) eventually becomes refractory to drug treatment and adding of a third agent or an analgesic drug (opioid or a non-steroidal anti-inflammatory agent) does not improve therapeutic success.

Therapy with antiepileptic agents is also associated with side effects, most prominently dizziness, drowsiness, and ataxia.

Many antiepileptic agents have the potential to cause rare but serious reactions.

Specific side effects of these surgical interventions are sensory loss (numbness) and / or dysesthesia (e.g. analgesia dolorosa) in the distribution of the trigeminal nerve.

Micro-vascular decompression in particular can be complicated by the occurrence of meningitis, cerebrospinal fluid leaks, or cranial nerve deficits.

It is clear that migraine, cluster and tension headaches as well as trigeminal neuralgia can be debilitating to individuals and significantly impair their quality of life.

To date, there does not appear to be a class of drugs or a treatment regimen that is effective for a majority of patients suffering from primary or secondary headaches or suffering from trigeminal neuralgia.

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