New data propel headache neuromodulation devices toward approval

The pivotal Pathway CH-1study that led to European Union approval was small – just 43 patients – but found that half the cluster attacks could be terminated within 15 minutes of onset. About half of the patients, who had a decades-long history of cluster headaches, experienced close to a 90% reduction in attack frequency.

The latest Pulsante data were also presented in June at the AHS meeting. Two papers – one with 24-month data from the pivotal trial, and one with 12-month data from an ongoing registry study – were overwhelmingly positive, Dr. Tepper said.

The 24-month follow-up data to the pivotal study found that 61% of patients experienced a therapeutic response to SPG stimulation. Most attacks (79%) responded to stimulation alone without the need for abortive therapy. Most patients (64%) also experienced clinical improvements in preventive medication use. Twenty-one were able to reduce or even eliminate the use of preventive medications.

The registry study provided data on 85 patients. Of these, 68% experienced at least a 50% reduction in attack frequency; some reported close to a 90% reduction. A third of patients actually experienced some period of remission, and some patients who were not initially responders became responders after a year of treatment. Acute medication use declined by 52% overall and by 82% in those considered therapeutic responders.

“These data are extremely encouraging,” Dr. Tepper said.

Adverse events are minimal and most are related to implantation. A safety study of 99 patients found that adverse events included sensory disbranch, pain, and swelling, which resolved in 90 days.

The U.S. Pathway CH-2 Cluster Headache Study is now underway and aims to enroll 120 patients. “If the data are positive on this, the company will go ahead and pursue U.S. approval,” Dr. Tepper said.

Dr. Tepper has received personal remuneration and research funding from a number of pharmaceutical companies. He holds stock in Autonomic Technologies.

msullivan@frontlinemedcom.com

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