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DRUG
& REFERENCE INFORMATION

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Cluster Headache

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Pediatric Headache

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Tension Headache

WASHINGTON, DC — A minimally
invasive, implantable investigational device that facilitates on-demand patient
treatment may help ease the crippling pain and significant psychosocial burden
of so-called suicide headaches.

A study
examining the long-term safety and efficacy of sphenopalatine ganglion (SPG)
stimulation in relieving acute cluster headache pain showed that two thirds of
more than 5000 cluster headache (CH) attacks evaluated during long-term
follow-up were effectively treated.

The
study was presented here at the American Academy of Neurology (AAN) 67th Annual
Meeting by lead investigator Jose Miguel Láinez, MD, PhD, Catholic University
of Valencia in Spain.

Severe
Pain

A
highly disabling chronic condition, CH is characterized by intense stabbing
pain in the area of one eye and is often accompanied by swelling, tears, and
nasal congestion. Attacks occur multiple times per day and last between 15 and
180 minutes.

Often
called “suicide headache,” CH pain is recognized as among the most
severe known to humans, said Dr. Láinez, noting that 15% to 22% of patients
have suicidal ideation.

Prevalence
estimates of CH are similar to those of Parkinson’s disease and multiple
sclerosis and affect approximately 375,000 individuals in the United States.

Part of
the autonomic nervous system, the SPG is a nerve bundle located behind the nose
and is directly involved in the generation of cluster headache pain.

While
it has been a treatment target for CH for more than a century, Dr Láinez noted
that the benefits of prior SPG interventions are often transient and sometimes
destructive and that long-term relief requires repeat procedures. This
highlights the need for new treatment options.

The ATI
Neurostimulation System used by the researchers in the study is a minimally
invasive technique. The device, which is smaller than an almond, is inserted
through a small incision in the upper gum and positioned at the SPG nerve
bundle on the same side as the patient’s headache pain. It leaves no visible
scars and can be reversed and adjusted to control CH pain.

After
implantation, patients can treat their pain on-demand by placing a handheld
remote control on the cheek over top of the ATI Neurostimulator.

Approved
for use in Europe, the device has been shown to be safe and effective.

In
early 2013 the investigators published results of the randomized,
controlled, blinded prospective multicenter study in Cephalalgia. Known as the
Pathway CH-1 study, it showed that SPG stimulation using the ATI
Neurostimulation System was effective in patients with chronic CH, relieving
acute pain and preventing CH attacks.

In the
current analysis, investigators examined acute response to SPG stimulation
therapy during long-term follow-up, which began 12 to 15 months after insertion
of the device.

The
interim population analysis evaluated the acute response to SPG in 33 patients
with CH enrolled in the long-term follow-up trial and included data on 5132 attacks.

Each
attack treated with SPG stimulation therapy was evaluated for effective
therapy, which was defined as relief or freedom from moderate, severe, or very
severe pain or freedom from mild pain.

The
average age of study patients was 41 years; 85% of patients were male. The mean
disease duration was 10.5 years, and the mean CH attack frequency at baseline
was 17 attacks per week (range, 5 to 70 attacks per week). The average duration
of SPG stimulation was 14 minutes (range, 3 to 39 minutes).

The researchers
found that SPG stimulation was an effective therapy for 65% (3354) of treated
attacks and ineffective therapy in 35%.

Of the
treated attacks, 22% were mild, 47% moderate, 22% severe, and 9% very severe.
SPG stimulation was effective in 59% of mild attacks, 78% of moderate attacks,
62% of severe attacks, and 21% of very severe attacks.

In
addition, he noted, 77% of treated attacks did not require the use of
additional acute medication.

The
results from this interim analysis, concluded Dr. Láinez, “continue to
support the use of on-demand SPG stimulation as a highly effective abortive
therapy.”

New
Treatments Welcome

Commenting
on the findings for Medscape
Medical News, Mia Minen, MD, director of headache services and
assistant professor, New York University Langone Medical Center, New York, said
SPG stimulation may offer a novel treatment option for patients with CH.

Dr
Minen noted that CHs are notoriously difficult to treat, particularly in
patients in whom standard treatments have little or no effect.

“A
lot of providers would love to have additional treatment options, and I think
headaches specialists are quite excited by the idea of SPG stimulation. When
you look at the study results, few patients required abortive medications for
their attacks and so to me this shows that SPG stimulation may offer an
effective option for these difficult-to-treat headaches,” said Dr Minen.

The
study was supported by Autonomic Technologies Inc. Dr Láinez and Dr Minen have
disclosed no relevant financial relationships.

American
Academy of Neurology (AAN) 67th Annual Meeting. Abstract S23.005. Presented
April 22, 2015.