The first refractory epilepsy patients have been implanted with Prometra II programmable infusion pumps for a clinical trial of the dose-delivery devices, according to the product’s developers, Flowonix Medical and Cerebral Therapeutics.
Dan Abrams, Cerebral Therapeutics’ CEO, said the multi-center ADDRESS trial is the first study of programmable, implantable pumps delivering medication directly to the brain — what is called intracerebroventricular delivery.
ADDRESS, which stands for Australian Direct Drug Administration for Refractory Epilepsy, will deliver valproate (valproate sodium) to patients with focal seizures who have temporal lobe onset, with or without secondary generalization.
The dose-ranging trial of the Prometra II Programmable Pump, at St. Vincent’s Hospital in Melbourne, is expected to enroll nine patients.
Doctors involved in the study are encouraged by preliminary indications that the device reduces seizures.
The Prometra II controls drug delivery to a region of the brain associated with medically refractory epilepsy. This is an uncontrolled, intractable, or drug-resistant epilepsy that occurs when medications fail to bring seizures under control.
“We are really excited to be able to study this new treatment option for patients in the ADDRESS trial – it may offer new hope to those with uncontrolled epilepsy,” Mark Cook, chair of medicine and director of Neurosciences at St. Vincent’s Hospital, said in a press release.
“The ability to target-deliver anti-epilepsy medication through an established infusion pump delivery could be a treatment with profoundly positive ramifications,” Ashwini Sharan, neurosurgical and neurological professor at Jefferson University, and president of the North American Neuromodulation Society, said. “This is the first time in the world this approach is being taken.”
“Neurological disorders can be devastating to patients and their families, who are often left with few options,” said Larry Heaton, chief executive officer of Flowonix Medical. “Flowonix is emerging as a world leader in implantable drug infusion systems used to treat pain, and we have particular expertise in the accurate and reliable delivery of microdoses of medication.
“As the first trial of its kind, the ADDRESS study is a significant milestone for Flowonix Medical, Inc., Cerebral Therapeutics, the healthcare community, and patients worldwide,” he added. “If the clinical study results in demonstrated positive outcomes, it would benefit patients who have refractory epilepsy and establish targeted drug delivery directly to the brain. It is gratifying when technological advancements offer such exciting possibilities for a new group of patients in need.”